Dr. Agravat Dental Clinic Implant Wellness Center Integrates 10-Minute Blinkit Delivery 2026-10-25 · freePRnow · Healthcare, Retail, Medical devices http://www.freePRnow.com/pr/dr-agravat-dental-clinic-implant-wellness-center-integrates-10-minute-blinkit-delivery This clinical-to-quick-commerce bridge eliminates traditional 3- to 7-day e-commerce shipping delays, allowing patient ———————————————————————————————————————————————————————————— THE RAIMONDO LAW FIRM SECURES $325,000 MEDIATION SETTLEMENT FOR HARDWARE STORE CUSTOMER INJURED BY FALLING TOOLBOXES 2026-10-24 · EIN Presswire · Healthcare, Legal, Medical devices https://www.einpresswire.com/article/951843365/the-raimondo-law-firm-secures-325-000-mediation-settlement-for-hardware-store-customer-injured-by-falling-toolboxes Attorney MICHAEL RAIMONDO Attorney DAVID J. RAIMONDO Attorney JON L. RAIMONDO THE CUSTOMER’S NECK INJURIES REQUIRED SURGERY AND PERMANENT MEDICAL IMPLANTS AFTER RETAILER FAILED TO KEEP OVERHEAD MERCHANDISE SECURE When choices and negligence result in a severe injury, surgery, and permanent hardware, we fight for the compensation that the victim is owed.” — Michael A. Raimondo, Esq. LAKE GROVE, NY, UNITED STATES, Octo ———————————————————————————————————————————————————————————— The Healthcare Technology Report Announces The Top MedTech Companies of 2026 2026-10-24 · PRWeb · Medical devices https://www.prweb.com/releases/the-healthcare-technology-report-announces-the-top-medtech-companies-of-2026-302917765.html The Healthcare Technology Report is pleased to announce The Top MedTech Companies of 2026. NEW YORK, Oct. 24, 2026 -- The Healthcare Technology Report is pleased to announce The Top MedTech Companies of 2026. Some of the most consequential advances in medicine come from... ———————————————————————————————————————————————————————————— Certus Hearing Launches Certus Max, a Bluetooth Hearing Aid With a Touchscreen Case 2026-10-24 · ACCESS Newswire · Entertainment, Medical devices https://finance.yahoo.com/healthcare/articles/certus-hearing-launches-certus-max-112000461.html Receiver-in-canal design streams phone calls and music to both ears, fits smaller ear canals and includes a 90-day home trial MIAMI, FL / October 24, 2026 / Certus Hearing today announced the launch of Certus Max, a certified rechargeable receiver-in-canal hearing aid for adults with perceived mild to mo ———————————————————————————————————————————————————————————— Robotic Dental Implant Surgery Comes to Wallingford 2026-10-23 · EIN Presswire · Healthcare, Travel, Medical devices https://www.einpresswire.com/article/951884873/robotic-dental-implant-surgery-comes-to-wallingford Wolfy Dental Group is the first Wallingford dental practice to offer robot-guided implant placement with the FDA-cleared Yomi system. WALLINGFORD, CT, UNITED STATES, October 23, 2026 / EINPresswire.com / -- Patients in Wallingford and the greater New Haven area no longer need to travel to a hospital or a specialty surgical center for robot-assisted dental implants. Wolfy Dental Group, led by Dr. Sandra Vukovic, DDS, ———————————————————————————————————————————————————————————— Quest Diagnostics Data Breach Investigation: Edelson Lechtzin LLP Probes Class Action Claims After Unauthorized Access to Patient Records 2026-10-23 · PR Newswire · Healthcare, Cybersecurity, Legal, Medical devices https://www.prnewswire.com/news-releases/quest-diagnostics-data-breach-investigation-edelson-lechtzin-llp-probes-class-action-claims-after-unauthorized-access-to-patient-records-302918491.html National class action law firm offers free, confidential case evaluations to Quest Diagnostics patients and others whose information may have been exposed. SECAUCUS, N.J., Oct. 23, 2026 -- Edelson Lechtzin LLP, a national class action law firm, is investigating data privacy... ———————————————————————————————————————————————————————————— Orthofix to Report Third Quarter 2026 Financial Results 2026-10-23 · Business Wire · Finance, Healthcare, Medical devices https://finance.yahoo.com/healthcare/articles/orthofix-report-third-quarter-2026-200000888.html Company to Host Conference Call on Monday, November 9, 2026, at 8:30 am Eastern Time LEWISVILLE, Texas, October 23, 2026--Orthofix Medical Inc . (NASDAQ:OFIX), a leading global medical technology company, today announced that it will release its third quarter 2026 financial results on Monday, November ———————————————————————————————————————————————————————————— Technical SEO Montgomery, AL: Why Diagnostics Matter for Local Businesses 2026-10-23 · MarketersMEDIA · Marketing & advertising, Medical devices https://news.marketersmedia.com/technical-seo-montgomery-al-why-diagnostics-matter-for-local-businesses/89207207 Four Star Digital Highlights Importance of Technical SEO Diagnostics for Alabama local Businesses, local business contractors, SEO agencies, and marketing freelancers. -- MONTGOMERY, AL — Four Star Digital - Technical SEO is drawing attention to the technical website conditions that can interfere with how local businesses appear in organic search results. For service companies, website performance involves more than ———————————————————————————————————————————————————————————— Roche presents interim phase III data showing sefaxersen significantly reduced proteinuria in people with IgA nephropathy (IgAN) 2026-10-23 · Roche · Healthcare, Biotech & pharma, Nonprofits, Internet & apps, Medical devices https://www.roche.com/media/releases/med-cor-2026-10-23 Sefaxersen achieved a statistically significant 43.1% reduction in proteinuria, a key indicator of kidney damage, relative to placebo at 37 weeks with consistent treatment effects across all prespecified patient subgroups1 As the first antisense oligonucleotide (ASO) evaluated in IgAN, sefaxersen inhibits complement factor B production and has the potential to slow IgAN disease progression by reducing kidney inflammation2 Investigational sefaxersen is intended to be a once-monthly subcutaneous injection and designed to enable convenient self-administration at home3 Despite recent advances, many people with IgAN remain at risk of disease progression and kidney failure, highlighting the need for additional targeted treatment options for those who do not respond to initial therapy4,5 Basel, 23 October 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today late-breaking oral presentation data from the ongoing phase III IMAgINATION study in adults with primary IgA nephropathy (IgAN) receiving optimised standard of care, demonstrating that investigational sefaxersen achieved a statistically significant and clinically meaningful 43.1% reduction in proteinuria (95% confidence interval [CI]: 32.5 - 52.0, P<0.0001), relative to placebo at 37 weeks, as measured by 24-hour urine protein-to-creatinine ratio (UPCR).1 Proteinuria is a key indicator of kidney damage and a reduction in UPCR is strongly associated with the preservation of long-term kidney function.6,7 Results presented at the American Society of Nephrology (ASN) Kidney Week 2026 also showed that, among patients with baseline haematuria (blood in urine), a greater proportion of patients achieved haematuria resolution at Week 37 with sefaxersen versus placebo.1 “These phase III results demonstrate the potential for sefaxersen to meaningfully reduce protein in the urine, a key indicator of kidney damage, in people with IgA nephropathy,” said Levi Garraway, MD, PhD, Roche's Chief Medical Officer and Head of Global Product Development. “By inhibiting complement factor B in the liver, sefaxersen may offer a novel approach to slow disease progression in IgAN, potentially helping patients delay or avoid long-term dialysis or kidney transplantation.” The treatment effect in all prespecified subgroups was consistent with the clinically meaningful reductions in proteinuria shown in the primary endpoint results.1 Sefaxersen was well tolerated with a safety profile consistent with the previously reported phase II study, exhibiting no new safety signals.1,2 Sefaxersen is an investigational once-monthly subcutaneous injection designed to enable convenient self-administration for people with IgAN.3 The IMAgINATION study will continue as a blinded study to evaluate the change in kidney function over two years, as measured by estimated glomerular filtration rate (eGFR) at week 105. Data will be shared with health authorities, with the goal of bringing this treatment to patients as soon as possible. Typically diagnosed before the age of 40, IgAN affects at least 25 adults per million worldwide each year.8,9 IgAN, also known as Berger’s disease, is a chronic and progressive autoimmune disease that leads to end-stage kidney disease in up to 50% of patients within 20 years of diagnosis.5,10 It is the most common form of primary glomerulonephritis (inflammation of the tiny filters, glomeruli, in the kidneys) and is a major cause of chronic kidney disease as well as kidney failure.8 About sefaxersen Investigational sefaxersen is the first highly specific liver-directed antisense oligonucleotide (ASO) inhibitor of factor B production being evaluated in IgA nephropathy (IgAN).2 Serum complement factor B levels are elevated in people with IgAN. When we reduce these levels, it in turn reduces the level of protein in urine, which is a key indicator of improved kidney function.11,12 Sefaxersen is designed to provide sustained control of the alternative complement pathway, an important pathway in IgAN, enabling once-monthly subcutaneous dosing and is intended for self-administration in people with IgAN.3 In phase I and II trials, sefaxersen was shown to be generally well tolerated in healthy volunteers and people with IgAN who were at high risk of progression, and reduced proteinuria and plasma complement factor B.2,13 Roche licensed sefaxersen from Ionis Pharmaceuticals for the treatment of complement mediated diseases. About the IMAgINATION study IMAgINATION [NCT05797610] is a phase III, multicentre, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of subcutaneous sefaxersen, an investigational antisense inhibitor of complement factor B, in patients with primary IgA nephropathy at high risk of progression.1,14 The study enrolled 459 people, who are randomised 1:1 to receive sefaxersen or placebo for 105 weeks.1,14 Participants may switch to open-label treatment after week 105 at the investigator's discretion or after the common-close timepoint, whichever occurs first.1,14 The primary endpoint of the study is the change from baseline in the urine protein-to-creatinine ratio at 37 weeks.1,14 About primary immunoglobulin A nephropathy (IgAN) IgAN, also known as Berger’s disease, is a serious, chronic and progressive autoimmune kidney disease affecting at least 25 adults per million worldwide each year and is typically diagnosed before the age of 40 years.8-10 In IgAN, immune complexes deposit in the kidneys, which activates the complement system’s alternative pathway, leading to inflammation and subsequent kidney damage.15 It is the most common form of primary glomerulonephritis (inflammation of kidney glomeruli) and remains a leading cause of kidney failure, with up to 50% of patients experiencing end-stage kidney disease within 20 years of diagnosis.5,8 Many current therapies aim to reduce protein levels in the urine and control blood pressure to slow progression of the disease.16 Updated KDIGO 2025 guidelines* highlight the need to address both the underlying immune-mediated causes of IgAN and the downstream consequences of kidney damage.4 While new therapies have expanded treatment options, important unmet needs remain, including improved long-term preservation of kidney function and more targeted approaches that address key drivers of disease progression.4,16 About Roche in Immunology For over two decades, Roche has advanced immune system research, creating groundbreaking targeted treatments that have transformed care for people with blood disorders, neurological conditions and autoimmune diseases. With a development pipeline exploring more than 20 medical approaches, we are targeting widespread, complex conditions like chronic lung disease (COPD) and inflammatory bowel disease (IBD), alongside lupus and autoimmune kidney diseases. Our ultimate goal is to lessen the burden of chronic immune disorders on patients, healthcare systems, and society. About Roche Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions. Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them. Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law. *KDIGO guidelines serve as the foundational framework for healthcare organisations, policymakers, and clinicians worldwide to standardise kidney disease diagnosis, staging, and treatment. References [1] Barratt J., et al. Sefaxersen, a Novel mRNA-Targeted Therapy for IgA Nephropathy: Interim Analysis of the Phase 3 IMAgINATION Trial. Presented at: ASN Kidney Week; 2026 Oct 20-26; Denver, CO, USA. Abstract #FR-OR104. [2] Barbour SJ, et al. A single-arm phase 2 trial of an investigational RNA therapeutic to complement factor B sefaxersen for treatment of IgA nephropathy. Kidney Int. 2026;109:592-601. [3] Barratt J, et al. IMAGINATION: a global phase 3 trial of RO7434656, an antisense oligonucleotide inhibitor of complement factor B, in IgA nephropathy. Kidney Int Rep. 2024;9 Suppl. WCN24-912. [4] Kidney Disease: Improving Global Outcomes (KDIGO) IgAN and IgAV Work Group. KDIGO 2025 Clinical Practice Guideline for the Management of Immunoglobulin A Nephropathy (IgAN) and Immunoglobulin A Vasculitis (IgAV). Kidney Int. 2025;108(4S):S1–S71. [5] Caster DJ, et al. Clinicopathological characteristics of adult IgA nephropathy in the United States. Kidney Int Rep. 2023;8:1792-1800. [6] Longhitano E, et al. Proteinuria and Progression of Renal Damage: The Main Pathogenetic Mechanisms and Pharmacological Approach. Medicina (Kaunas). 2024 Nov 6;60(11):1821. [7] Qin X, et al. Association Between Urinary Protein-to-Creatinine Ratio and Chronic Kidney Disease Progression: A Secondary Analysis of a Prospective Cohort Study. Front. Med. 2022; 9:854300. [8] Pitcher D, et al. Long-term outcomes in IgA nephropathy. Clin J Am Soc Nephrol. 2023;18:727-738. [9] McGrogan A, Franssen CF and de Vries CS. The incidence of primary glomerulonephritis worldwide: a systematic review of the literature. Nephrol Dial Transplant 2011; 26: 414-430. [10] Cleveland Clinic. IgA Nephropathy [Internet; cited 2026 October 15]. Available from: https://my.clevelandclinic.org/health/diseases/5990-iga-nephropathy. [11] Chiu YL, et al. Alternative complement pathway is activated and associated with galactose-deficient IgA. Front Immunol 2021; 12: 638309. [12] Marques F, et al. Impact of early proteinuria reduction in glomerular disease and decline of kidney function: a retrospective cohort. J Clin Med. 2022;11(19):5968. [13] McCaleb ML, et al. Inhibiting the alternative pathway of complement by reducing systemic complement factor B: Randomized, double-blind, placebo-controlled phase 1 studies with Sefaxersen. Immunobiology. 2025 Mar;230(2):152876. [14] ClinicalTrials.gov. A Study to Evaluate RO7434656 in Participants With Immunoglobulin A Nephropathy (IgAN) (IMAGINATION) (NCT05797610) [Internet; cited 2026 Oct 15]. Available from: https://clinicaltrials.gov/study/NCT05797610. [15] Wu MY, et al. The emerging role of pathogenesis of IgA nephropathy. J Clin Med. 2018;7:225. [16] Floege J, et al. Current treatment of IgA nephropathy. Semin Immunopathol. 2021;43:717-728. Roche Global Media Relations Phone: +41 61 688 88 88 / e-mail: media.relations@roche.com Tristan Schmitz Phone: +41 79 529 70 35Lorena Corfas Phone: +41 79 568 24 95 Simon Goldsborough Phone: +44 797 32 72 915Karsten Kleine Phone: +41 79 461 86 83 Kirti Pandey Phone: +41 79 398 38 53Yvette Petillon Phone: +41 79 961 92 50 Irène Stephan Phone: +41 79 377 83 75Albert Thottiyil Phone: +41 79 775 66 12 Roche Investor Relations Dr Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.comDr Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com Dr Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com  Investor Relations North America Loren Kalm Phone: +1 650 225 3217 e-mail: kalm.loren@gene.com  Attachment Media Investor Release Sefaxersen IMAgINATION ASN ———————————————————————————————————————————————————————————— Latent TB Diagnostics Market Report Now Available — Reveals Why Rising Prevalence and Rapid, Multiplex Testing Are Expanding Options Even as Cost Pressure Squeezes the Market 2026-10-23 · GlobeNewswire · Medical devices https://www.globenewswire.com/news-release/2026/10/23/3387402/28124/en/latent-tb-diagnostics-market-report-now-available-reveals-why-rising-prevalence-and-rapid-multiplex-testing-are-expanding-options-even-as-cost-pressure-squeezes-the-market.html 322-Page Report Profiles 18 Companies and Forecasts Five-Year Market Size by Assay, Risk Factor and Lab/Place, Examining How Aging Populations and Testing Outside the Lab Reshape Demand 322-Page Report Profiles 18 Companies and Forecasts Five-Year Market Size by Assay, Risk Factor and Lab/Place, Examining How Aging Populations and Testing Outside the Lab Reshape Demand ———————————————————————————————————————————————————————————— Global Aneurysm Clip Market Size, Share, Trends, and Forecast 2026-2032 | Endovascular Adoption Drives a -0.7% CAGR, While Specialized Surgical Demand Supports Durable Revenue 2026-10-23 · GlobeNewswire · Finance, Medical devices https://www.globenewswire.com/news-release/2026/10/23/3387400/28124/en/global-aneurysm-clip-market-size-share-trends-and-forecast-2026-2032-endovascular-adoption-drives-a-0-7-cagr-while-specialized-surgical-demand-supports-durable-revenue.html Target morphology-driven niches, younger patients prioritizing durable repair, and MRI-compatible, ultra-slim or PEEK clips as endovascular alternatives gain share. Target morphology-driven niches, younger patients prioritizing durable repair, and MRI-compatible, ultra-slim or PEEK clips as endovascular alternatives gain share. ———————————————————————————————————————————————————————————— Clinical Laboratory Molecular Diagnostics for Infectious Diseases Market, 2025-2029: Forecast by Application, Place, and Country | Multiplex and Rapid Testing Unlock Growth 2026-10-23 · GlobeNewswire · Healthcare, Medical devices https://www.globenewswire.com/news-release/2026/10/23/3387386/28124/en/clinical-laboratory-molecular-diagnostics-for-infectious-diseases-market-2025-2029-forecast-by-application-place-and-country-multiplex-and-rapid-testing-unlock-growth.html A 354-page report profiles 36 companies, including Abbott, bioMérieux, Roche and Thermo Fisher, across respiratory, gastrointestinal and meningitis testing in 15 countries — though costs and shifting disease prevalence complicate the outlook A 354-page report profiles 36 companies, including Abbott, bioMérieux, Roche and Thermo Fisher, across respiratory, gastrointestinal and meningitis testing in 15 countries — though costs and shifting disease prevalence complicate the outlook ———————————————————————————————————————————————————————————— Iron Mountain Orthopaedic Institute Formalizes Standardized PRP Protocol for Non-Surgical Joint and Tendon Care 2026-10-23 · PR Now · Medical devices https://pressreleasenews.org/pressroom/iron-mountain-orthopaedic-institute-formalizes-standardized-prp-protocol-for-non-surgical-joint-and-tendon-care Every injection is ultrasound-guided. Platelet concentration is verified before treatment. And if PRP isn't the right answer, the practice will say so. Huntingdon Valley, PA, September 7, 2026 - Iron Mountain Orthopaedic Institute, the Huntingdon Valley orthopaedic practice found… ———————————————————————————————————————————————————————————— Portable Ultrasound Market Expansion Supported by Healthcare Innovation at 12.55% CAGR 2026-10-23 · PR News Releaser · Medical devices https://www.prnewsreleaser.com/news/478050 The Portable Ultrasound Market size was valued at US$ 3.55 Billion in 2025 and is projected to reach US$ 9.14 Billion by 2033, growing at a CAGR of 12.55% during 2026–2033. The retrieved public source material for this batch did ... Read more ———————————————————————————————————————————————————————————— Clockworks Analytics Reveals Sprocket AI Chat: Ask Your Buildings Anything 2026-10-23 · PRWeb · AI, SaaS, Medical devices https://www.prweb.com/releases/clockworks-analytics-reveals-sprocket-ai-chat-ask-your-buildings-anything-302917748.html New AI assistant gives facilities teams answers backed by their own building data, with links straight to the diagnostics, tasks, and insights behind every figure BOSTON, Oct. 23, 2026 -- Clockworks Analytics, a smart building intelligence platform for facility and... ———————————————————————————————————————————————————————————— Avanos CHRO Camille Chang Gilmore Receives Inaugural Seramount Ted Childs Award 2026-10-23 · PR Newswire · Healthcare, Jobs & workplace, Medical devices https://www.prnewswire.com/news-releases/avanos-chro-camille-chang-gilmore-receives-inaugural-seramount-ted-childs-award-302917541.html Recognition honors courageous leadership and workforce strategies that advance opportunity and performance ALPHARETTA, Ga., Oct. 23, 2026 -- Avanos Medical, Inc., a leading medical technology company, today announced that Camille Chang Gilmore, senior vice president and chief... ———————————————————————————————————————————————————————————— Coreline Soft Receives U.S. FDA 510(k) Clearance for AVIEW Aorta Metrics, Expanding Its Chest CT AI Portfolio in the U.S. 2026-10-23 · PR Newswire · AI, Healthcare, Medical devices https://www.prnewswire.com/news-releases/coreline-soft-receives-us-fda-510k-clearance-for-aview-aorta-metrics-expanding-its-chest-ct-ai-portfolio-in-the-us-302916220.html Secures its 13th FDA 510(k) clearance, expanding its U.S. portfolio from lung nodule detection and coronary artery calcium (CAC) analysis to quantitative aortic assessment Enables automated aortic segmentation and diameter measurements across anatomical regions, broadening the... ———————————————————————————————————————————————————————————— Humacyte at ASN Kidney Week: Phase 3 Trial Built for Women Shows ATEV Advantage Over Fistula, Getting Patients Off Catheters Months Sooner 2026-10-23 · GlobeNewswire · Healthcare, Biotech & pharma, Medical devices https://www.globenewswire.com/news-release/2026/10/23/3387207/0/en/humacyte-at-asn-kidney-week-phase-3-trial-built-for-women-shows-atev-advantage-over-fistula-getting-patients-off-catheters-months-sooner.html - The presenter, Dr. Roy-Chaudhury said, “These results give the nephrology community a strong reason to rethink our approach to access decisions for women and, once approved by the FDA, to consider the ATEV as a meaningful new option.” ———————————————————————————————————————————————————————————— Creative Diagnostics Highlights Chagas Disease Model to Support Antiviral and Antiparasitic Drug Discovery 2026-10-23 · MarketersMEDIA · SaaS, Biotech & pharma, Medical devices https://news.marketersmedia.com/creative-diagnostics-highlights-chagas-disease-model-to-support-antiviral-and-antiparasitic-drug-discovery/89207089 Creative Diagnostics announces the expansion of its preclinical evaluation platform with comprehensive Chagas Disease Model development services. -- As an expert in providing solutions to assist virology and microbiology research, Creative Diagnostics has announced the expansion of its preclinical evaluation platform with comprehensive Chagas Disease Model development services. These new in vivo solutions can support ———————————————————————————————————————————————————————————— Super Vision Technology: World’s first i-NYS implant for congenital nystagmus in a Chinese boy 2026-10-23 · GlobeNewswire · Healthcare, Education, Medical devices https://www.globenewswire.com/news-release/2026/10/23/3387168/0/en/super-vision-technology-world-s-first-i-nys-implant-for-congenital-nystagmus-in-a-chinese-boy.html BEIJING, Oct. 23, 2026 -- A 9-year-old boy has become the world's first patient to receive a newly approved implant to treat congenital nystagmus, in a procedure performed at Peking University People's Hospital. This marks that the technology has moved from regulatory clearance to clinical practice. ———————————————————————————————————————————————————————————— Treace to Report Third Quarter 2026 Financial Results on November 6, 2026 2026-10-23 · GlobeNewswire · Healthcare, Medical devices https://www.globenewswire.com/news-release/2026/10/23/3387164/0/en/treace-to-report-third-quarter-2026-financial-results-on-november-6-2026.html PONTE VEDRA, Fla., Oct. 23, 2026 -- Treace Medical Concepts, Inc. (“Treace” or the “Company”) (NasdaqGS: TMCI), a medical technology company driving a fundamental shift in the surgical treatment of bunions and related midfoot deformities, today announced that it will release financial results for the third quarter 2026 before the start of trading on Friday, November 6, 2026. Company management will host a conference call to discuss financial results beginning at 8:00 am ET. ———————————————————————————————————————————————————————————— Foundation Medicine’s FoundationOne®MRD Named a 2026 Top Innovation Winner by The Scientist 2026-10-23 · Business Wire · Healthcare, Medical devices https://finance.yahoo.com/healthcare/articles/foundation-medicine-foundationone-mrd-named-110000378.html First-of-its-kind molecular residual disease test combining structural variants and digital PCR recognized for enabling ultra-sensitive molecular disease detection, with high specificity, in the Healthcare and Diagnostics category BOSTON, October 23, 2026--Foundation Medicine, Inc ., a global, patient ———————————————————————————————————————————————————————————— Nanotechnology In Medical Devices Market: 6.17% CAGR Signals Steady Growth Through 2033 2026-10-23 · PR News Releaser · Healthcare, Medical devices https://www.prnewsreleaser.com/news/477703 The Nanotechnology In Medical Devices Market size is expected to reach US$ 6.57 Billion by 2033 from US$ 4.07 Billion in 2025. The market is estimated to record a CAGR of 6.17% from 2026 to 2033. Market growth is best ... Read more ———————————————————————————————————————————————————————————— Influenza Diagnostics Market Trends Shaping Respiratory Testing in 2026 2026-10-23 · Express Press Release · Medical devices https://express-press-release.net/news/2026/10/23/1778208 The global influenza diagnostics market was valued at USD 1.6 billion in 2023 and is projected to reach USD 2.4 billion by 2030, expanding at [read full press release...] ———————————————————————————————————————————————————————————— Magnetic Particle Imaging Market to Reach US$ 612 Million by 2034, Growing at 20.11% CAGR 2026-10-23 · PR News Releaser · Healthcare, Medical devices https://www.prnewsreleaser.com/news/477280 The global Magnetic Particle Imaging market is expected to experience significant expansion through 2034, reflecting its growing potential in medical imaging, diagnostic research, and emerging healthcare technologies. The Magnetic Particle Imaging market size is projected to increase from US$ 117.60 ... Read more ———————————————————————————————————————————————————————————— How Uganda is bringing malaria care closer to every family 2026-10-23 · APO Group · Healthcare, Travel, Government & policy, Medical devices https://who-africa.africa-newsroom.com/press/how-uganda-is-bringing-malaria-care-closer-to-every-family?lang=en Whenever fever strikes nine-year-old Joshua Ekimwere in his rural Ogaramio village, getting help has not always been easy. For his grandmother, Akurut Dinah Loy, a suspected malaria infection often meant difficult choices. Either finding money for transport and medicine, missing a day's work, or waiting anxiously while his condition worsens. For years, this was the reality for many families in rural Uganda. Community-based malaria services helped protect children under five, but older children and adults often had to travel long distances to a health facility just to find out whether they had malaria and begin treatment. Today, that is changing. Through a Ministry of Health-led initiative, Village Health Teams (VHTs) and Community Health Extension Workers (CHEWs) are being trained and equipped to test people of all ages using rapid diagnostic tests and provide free lifesaving treatment within their communities. For Akurut Dinah Loy and her family, the difference has been significant. “It is frightening to watch a child become sick and not know how quickly you can get help. Having services nearby has changed a lot for our family,” she said. “Now, when Joshua gets sick, I no longer think first about the journey to the health facility. I think about getting him help quickly.” Improving access to timely care Uganda has made remarkable progress in the fight against malaria. Since 2000, malaria-related deaths have fallen by more than 50%, reflecting sustained investments in prevention, diagnosis and treatment. Yet malaria remains one of the country's most significant public health challenges. In 2025, an estimated 13.2 million malaria cases were reported, meaning roughly one in every 20 malaria cases worldwide occurred in Uganda. WHO estimates that between 16,000 and 20,000 people died from malaria during the same year. Many challenges affecting the fight against malaria include people reaching health services too late, waiting more than 24 hours after symptoms begin before seeking care and relying on poor-quality medicines or fail to complete treatment. These delays increase the risk of severe illness and place additional pressure on families and the health system. The expansion of community-based malaria services is helping address these challenges by making diagnosis and treatment available where people live, particularly in areas where access to health facilities remains difficult. For Dr Cathrine Maiteki Sebuguzi, Deputy Programme Manager at the National Malaria Elimination Department, timely access to care is critical to sustaining Uganda's progress. “Reaching communities where transmission occurs is the foundation of our efforts towards malaria elimination. Through this initiative, we are ensuring timely diagnosis, prompt treatment and protection of those most at risk,” said Dr Cathrine. Strengthening primary health care and advancing equity The initiative does more than improve access to malaria services. It strengthens primary health care by expanding the role of community health workers and ensuring that essential services reach people who might otherwise be left behind. Today, approximately 85,000 VHT members provide community-based health services across Uganda. Extending malaria diagnosis and treatment to all age groups helps address a larger reservoir of infection while improving equity in access to essential health services. The expansion of VHTs and CHEWs is part of Uganda's 24-2 Hours Initiative, which aims to ensure malaria diagnosis and treatment within 24 hours of symptom onset and lifesaving pre-referral treatment for severe malaria within two hours. By reaching rural, peri-urban and underserved communities, the initiative is helping accelerate progress towards Universal Health Coverage. “When health services are available closer to home, people can get help earlier. That is especially important for malaria, where timely diagnosis and treatment can save lives,” said Dr Christine Chiedza Musanhu, Team Lead for Disease Prevention and Control, WHO Uganda. “Community-based care also helps us reach people who might otherwise be left behind.” The programme is supported through a broad partnership involving the Global Fund, the United States Government and UNICEF. For Akurut Dinah Loy, the success of this initiative means knowing that when Joshua develops a fever, help is no longer a distant journey away. “As a grandmother, nothing is more important than seeing my grandchildren healthy. Knowing they can be tested and treated quickly gives our family comfort and hope,” added Loy. For families across Uganda, timely access to malaria services means fewer delays, less uncertainty and a better chance of receiving treatment when it matters most. And for Uganda, it is another step towards a future where no family's health is determined by how far they live from care. Distributed by APO Group on behalf of WHO Regional Office for Africa. ———————————————————————————————————————————————————————————— STEMart Introduces Gel Imaging System Solutions to Support Molecular Biology and Laboratory Research 2026-10-23 · EIN Presswire · Healthcare, Medical devices https://www.einpresswire.com/article/951699412/stemart-introduces-gel-imaging-system-solutions-to-support-molecular-biology-and-laboratory-research STEMart launches a range of Gel Imaging System solutions to support molecular biology research, electrophoresis analysis, and laboratory documentation. NEW YORK, NY, UNITED STATES, October 23, 2026 / EINPresswire.com / -- STEMart , a US-based provider of comprehensive services and technical solutions for all phases of medical device development, has launched a range of Gel Imaging System solutions to support molecula ———————————————————————————————————————————————————————————— Life Masters Introduces Cutting-Edge Leadership Alignment Program in SA 2026-10-23 · Newsworthy.ai · Finance, AI, SaaS, Jobs & workplace, Marketing & advertising, Medical devices https://newsworthy.ai/news/202610233088/life-masters-introduces-cutting-edge-leadership-alignment-program-in-sa JOHANNESBURG Friday Oct 23, 2026 @ 2:00 AM UTC — Life Masters, the Johannesburg-based high performance team development company led by founder Tony Dovale, has launched the Revolutionary Workplace® Leadership Alignment Accelerator, a programme and diagnostic process for repairing and aligning fractured executive, exco, management and board teams. Programmes are offered in Gauteng, South Africa, with bookings opening in January 2027. The launch addresses a common yet often unmeasured issue in South African organizations: misaligned leadership leading to strain throughout the company. Decision-making slows, strategies falter in execution, and board-level tension affects company culture and performance. "When an executive team is pulling in different directions, everything below it feels the strain, " said Tony Dovale, CEO, Life Masters.  "We built the Leadership Alignment Accelerator so management, executive and board teams can see clearly where they are out of step and work through it together. Starting with talks and board interview meetings lets us meet each team where it actually is." What the Accelerator is Life Masters' Accelerator integrates leadership team diagnostics with guided sessions. These diagnostics reveal fractures within the team and highlight misalignments among members concerning priorities, decision rights, trust, and communication. The facilitated sessions then work through those gaps with the whole team together, rather than with leaders one by one. The result is a shared, tested understanding of what the team is there to achieve and how it will make decisions, resolve conflict and hold each other to account. Who it is for The Accelerator is designed for management teams, executive teams and boards, particularly where: Decisions are slow or repeatedly reopened Strategy execution has stalled There is tension or distrust at board or exco level Leaders are pulling in different directions or working to competing priorities A new CEO, merger or restructure has left the leadership team unaligned How engagements work Each engagement is tailored to meet the specific outcomes desired by the client. Some run as a two-day leadership retreat. Others run as multi-month alignment and optimisation projects. The format depends on the organisation’s structure, locations, number of participants and the depth of process needed to resolve the fractureLeadership teams face mounting pressure to adapt swiftly amidst technological shifts, economic unpredictability, and evolving stakeholder demands. Without internal alignment, leading change becomes a formidable challenge. Life Masters' solutions are designed to address these challenges effectively.ns. A team that cannot align internally cannot lead changLeadership teams often fail not due to lack of talent but because they drift apart without measurement or resolution.rs. Where it fits The Accelerator is part of the Revolutionary Workplace® HPO Labs System and High Performance Teams experience. It extends Life Masters’ work on psychological safety, trust, collaboration and communication to the top of the organisation, where leadership teams are divided and need a structured way to work through the issues. Teams can move from the Accelerator into deeper work, including the High Performance Team Sprint, Execution Accelerator, Culture Reset or Executive Strategy Facilitation. Frequently asked questions What is leadership alignment? A leadership team is aligned when its members share priorities, decide and communicate consistently, and support decisions once made. How do you fix a divided executive team? By measuring where the team is out of step, then working through those gaps together in facilitated sessions, as the Accelerator does. How much does leadership alignment cost in South Africa? Entry-level interventions with Life Masters start from R35,000, with investment depending on the format, participants and depth of process. How long does an exco retreat take? Engagements range from a two-day retreat to multi-month projects. Start now Business Leadership Keynote talks and board or exco interview meetings are available immediately, ahead of programme bookings in January 2027. The interview meeting is the first step: a focused conversation to understand the team’s challenges and recommend the right format. Book a talk or interview meeting: revwork.lifemasters.co.za | Email Contact | +27 83 447 6300 Key facts Programme: Revolutionary Workplace Leadership Alignment Accelerator and diagnostics Entry level intervention investment starts from R35,000 Bookings begin January 2027, offered in Gauteng, South Africa For management, executive and board teams Founder: Tony Dovale. Website: lifemasters.co.za Questions about this announcement What is the Life Masters Leadership Alignment Accelerator? It is a new programme and diagnostic process from Life Masters for repairing and aligning fractured executive and business teams. It forms part of the Revolutionary Workplace HPO Labs System and High Performance Teams experience. How much does the Leadership Alignment Accelerator cost? Entry-level intervention investment starts from R35,000. The final scope depends on the client's structures, locations, participant numbers, and the depth of process facilitation required. When and where can teams book it? The launch begins now with talks and board or Exco interview meetings, with bookings starting in January 2027 in Gauteng, South Africa. ———————————————————————————————————————————————————————————— Important work from our team in Science Magazine today, showing how our diagnostic orchestrator can reason through complex medical cases, achieving greater diagnostic accuracy while reducing testing costs. 2026-10-23 · Microsoft · Healthcare, Medical devices https://www.linkedin.com/feed/update/urn:li:activity:7519138392542953472/ The post Important work from our team in Science Magazine today, showing how our diagnostic orchestrator can reason through complex medical cases, achieving greater diagnostic accuracy while reducing testing costs. appeared first on Source. ———————————————————————————————————————————————————————————— Neovii Advances FDA Fast Track-Designated ATLG Program in Type 1 Diabetes With Pivotal Phase 2 Study - Company Appoints Physician-scientist Salvatore Alesci as Chief Medical Officer 2026-10-22 · NewMediaWire · Healthcare, Food & drink, Industrial, Biotech & pharma, Medical devices https://www.newmediawire.com/news/neovii-advances-fda-fast-track-designated-atlg-program-in-type-1-diabetes-with-pivotal-phase-2-study-company-appoints-physician-scientist-salvatore-alesci-as-chief-medical-officer-7090826 BOSTON, MA and RAPPERSWIL-JONA, SWITZERLAND - October 22, 2026 - Neovii Pharmaceuticals AG, a Swiss-headquartered, commercial-stage biopharmaceutical company with more than four decades of experience in antibody-based immunotherapies, today announced that it is advancing its Type 1 Diabetes (T1D) clinical program through a company-sponsored pivotal Phase 2 study in the United States and European Union. The international expansion builds on the ongoing investigator-initiated European GIRO (Grafalon in early onset) T1D study and is supported by U.S. Food and Drug Administration (FDA) Fast Track designation for anti-T-lymphocyte globulin (ATLG) for the prevention of declining C-peptide production in patients with recent-onset T1D. Patients have already been treated in GIRO, and clinical data are being generated. The expected 12-month efficacy and safety interim analysis will provide an important near-term milestone and inform the pivotal study program. This next stage marks an important expansion beyond transplantation and reflects Neovii’s strategy to apply its expertise in immune modulation to autoimmune and immune-mediated diseases with strong biological rationale and significant unmet medical need. In connection with this expansion, Neovii has appointed Salvatore “Salvo” Alesci, M.D., Ph.D., as Chief Medical Officer, effective October 15, 2026. Dr. Alesci will lead the company’s medical and clinical development activities, including translational medicine and regulatory strategy. He will oversee the Type 1 Diabetes program and help shape the company’s broader clinical development strategy, including the evaluation of future development opportunities. Scientific Rationale for ATLG in Type 1 Diabetes Type 1 Diabetes is a chronic autoimmune disease characterized by T-cell-mediated destruction of insulin-producing pancreatic beta cells. Many patients retain residual beta-cell function following diagnosis, and preserving this endogenous function remains an important therapeutic objective. ATLG is a polyclonal anti-T-lymphocyte globulin with preferential activity against activated T cells and broader effects across T-cell populations and immune pathways involved in autoimmune responses. Published clinical proof of concept in recent-onset Type 1 Diabetes was reported by Saudek et al. in a placebo-controlled study of ATLG. Together with other clinical evidence that modulation of pathogenic T-cell responses can preserve residual beta-cell function, these findings provide a clinical and mechanistic rationale for evaluating ATLG in the ongoing GIRO T1D study and company-sponsored pivotal Phase 2 study. ATLG has been used in transplantation medicine for more than four decades. Building on this extensive manufacturing, preclinical, and clinical experience, Neovii is now evaluating its potential role in autoimmune disease. The investigator-initiated European GIRO T1D study and the company-sponsored pivotal Phase 2 study in the United States and the European Union are complementary components of the ATLG clinical development program. Neovii is using emerging efficacy and safety data from GIRO to inform the pivotal study and support ongoing discussions with the FDA, European regulatory authorities, and other health authorities on a potential registration pathway. Executive Commentary Frederic Prince, Ph.D., Chief Executive Officer of Neovii Pharmaceuticals AG, commented: “Despite major advances in glucose monitoring and insulin delivery, Type 1 Diabetes continues to impose a substantial burden on patients. ATLG’s well-characterized activity against activated T cells, clinical proof of concept in recent-onset disease, and extensive clinical experience provide a strong foundation for its further evaluation. Building on the investigator-initiated GIRO T1D study, we are advancing a company-sponsored pivotal Phase 2 study to assess whether ATLG can preserve endogenous beta-cell function and reduce treatment burden. "As we take this important step in expanding Neovii’s clinical development activities, I am also delighted to welcome Salvo to Neovii as our Chief Medical Officer. His expertise in endocrinology, translational medicine, and clinical development will be highly valuable as we advance our Type 1 Diabetes program and evaluate future opportunities in immune-mediated diseases.” Salvatore Alesci, M.D., Ph.D., Chief Medical Officer of Neovii Pharmaceuticals AG, said: “I am excited to join Neovii at this important stage in the company’s evolution and help drive its expansion into Type 1 Diabetes and other immune-mediated diseases. Despite significant advances in disease management, preservation of endogenous beta-cell function remains an important therapeutic objective in Type 1 Diabetes. ATLG provides an opportunity to rigorously evaluate a differentiated immunomodulatory approach in a randomized clinical setting. I look forward to working with the Neovii team, investigators, patients, advocacy groups, and regulatory authorities to execute a scientifically rigorous Type 1 Diabetes development program and shape the company’s broader clinical strategy in immune-mediated diseases.” About Salvatore Alesci, M.D., Ph.D. Dr. Alesci is a physician-scientist and biopharmaceutical executive with combined expertise in endocrinology and immunology and more than 25 years of experience spanning translational medicine, clinical development, regulatory strategy and scientific and patient affairs. Throughout his career, he has held senior leadership roles in biotechnology and pharmaceutical organizations, leading multidisciplinary global programs from early research through late-stage clinical development. About Neovii Pharmaceuticals AG Neovii Pharmaceuticals AG is a Swiss-headquartered, fully integrated biopharmaceutical company focused on developing, manufacturing, and commercializing antibody-based therapy for immune-mediated diseases. The company markets Grafalon® (ATLG, formerly named as ATG-F), an anti-human T-lymphocyte immunoglobulin approved in multiple countries for transplantation-related indications; approved uses vary by country. Grafalon is manufactured at Neovii’s dedicated biotechnology manufacturing facility in the Munich area and is commercialized in more than 50 countries. Building on decades of expertise in immune modulation, Neovii is expanding its research and development activities into selected autoimmune and immune-mediated diseases with significant unmet medical need. ATLG is investigational in Type 1 Diabetes and has not been approved for this use. Nothing in this release should be interpreted as promoting ATLG for an unapproved indication. Forward-Looking Statement This press release contains forward-looking statements regarding Neovii’s planned clinical development activities, regulatory interactions, clinical-study design and execution, business strategy, and potential future registration pathways. These statements are based on current beliefs, expectations, and assumptions and involve significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied. Clinical development outcomes, regulatory decisions, trial initiation and enrollment, safety and efficacy findings, development timelines, manufacturing readiness, and business objectives are subject to factors beyond Neovii’s control. Fast Track designation does not guarantee that ATLG will qualify for Accelerated Approval or Priority Review, that regulatory review will be completed within any particular timeframe, or that ATLG will receive marketing approval for Type 1 Diabetes. Neovii undertakes no obligation to update these forward-looking statements except as required by applicable law. Reference: Saudek, F., et al. The Review of Diabetic Studies, Vol. 1, No. 2, 2004. Media contact Neovii Pharmaceuticals AG, info@neovii.com, www.neovii.com ———————————————————————————————————————————————————————————— Catheter Precision Announces Publication of Comparative Study Showing LockeT Outperforms Abbott’s Perclose Internal Vascular Closure Device 2026-10-22 · GlobeNewswire · Finance, Aerospace & defense, Medical devices https://www.globenewswire.com/news-release/2026/10/22/3386951/0/en/catheter-precision-announces-publication-of-comparative-study-showing-locket-outperforms-abbott-s-perclose-internal-vascular-closure-device.html FORT MILL, S.C, Oct. 22, 2026 -- Catheter Precision, a wholly owned subsidiary of Flyte Aviation, Inc. (NYSE American: VJET), today announced the first published comparative study evaluating its LockeT suture retention device against a traditional internal vascular closure device (VCD) following large bore venous access. ———————————————————————————————————————————————————————————— CVRx to Report Third Quarter 2026 Financial and Operating Results and Host Conference Call on November 5, 2026 2026-10-22 · GlobeNewswire · Finance, Healthcare, Industrial, Medical devices https://www.globenewswire.com/news-release/2026/10/22/3386926/0/en/cvrx-to-report-third-quarter-2026-financial-and-operating-results-and-host-conference-call-on-november-5-2026.html MINNEAPOLIS, Oct. 22, 2026 -- CVRx, Inc. (NASDAQ: CVRX) ("CVRx"), a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases, today announced that it plans to release third quarter 2026 financial and operating results after market close on Thursday, Nov. 5, 2026. The Company will host a conference call to review its results at 4:30 p.m. Eastern Time the same day. ———————————————————————————————————————————————————————————— Nano-X Imaging (NNOX) Advances Its Mission to Expand Access to Medical Imaging 2026-10-22 · NewMediaWire · Finance, AI, SaaS, Healthcare, Media, Legal, Jobs & workplace, Medical devices https://www.newmediawire.com/news/nano-x-imaging-nnox-advances-its-mission-to-expand-access-to-medical-imaging-7090818 Nanox is working to make advanced medical imaging more accessible through digital 3D tomosynthesis technology designed to enhance visualization beyond conventional X-rays. Its Nanox.ARC platform combines imaging hardware with cloud-based infrastructure, while the company’s broader services support image interpretation and clinical workflows. By connecting image acquisition with remote radiology expertise and AI-powered analysis, Nanox aims to support healthcare providers’ imaging and interpretation workflows more efficiently. LOS ANGELES, CA - October 22, 2026 - Access to medical imaging remains an important consideration for healthcare systems, particularly in underserved regions where equipment, infrastructure and trained personnel may be limited. While conventional X-rays play an essential role in diagnostic care, their two-dimensional images can make certain anatomical details more difficult to distinguish when structures overlap. In some healthcare settings, rising imaging volumes and radiologist workforce constraints can also place pressure on diagnostic services. These challenges underscore the importance of developing imaging technologies that can complement existing diagnostic approaches while integrating into established clinical environments and workflows. Nano-X Imaging (NASDAQ: NNOX) is approaching that problem from a different direction. Nanox is assembling an integrated platform intended to extend medical imaging into outpatient facilities, clinics and other settings where conventional advanced… Read More Please see full terms of use and disclaimers on the InvestorBrandNetwork website applicable to all content provided by IBN, wherever published or re-published: https://IBN.ai/Disclaimer The latest news and updates relating to NNOX are available in the company’s newsroom at https://ibn.fm/NNOX Forward Looking Statements Certain statements in this article are forward-looking, as defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks, uncertainties, and other factors that may cause actual results to differ materially from the information expressed or implied by these forward-looking statements and may not be indicative of future results. These forward-looking statements are subject to a number of risks and uncertainties, including, among others, various factors beyond management's control, including the risks set forth under the heading "Risk Factors" discussed under the caption "Item 1A. Risk Factors" in Part I of the Company's most recent Annual Report on Form 10-K or any updates discussed under the caption "Item 1A. Risk Factors" in Part II of the Company's Quarterly Reports on Form 10-Q and in the Company's other filings with the SEC. Undue reliance should not be placed on the forward-looking statements in this article in making an investment decision, which are based on information available to us on the date hereof. All parties undertake no duty to update this information unless required by law. ———————————————————————————————————————————————————————————— FDA grants 510(k) clearance for BoneEnhance, the first machine learning layer on RIVANNA's Accuro XV platform 2026-10-22 · PR Newswire · AI, SaaS, Healthcare, Education, Biotech & pharma, Medical devices https://www.prnewswire.com/news-releases/fda-grants-510k-clearance-for-boneenhance-the-first-machine-learning-layer-on-rivannas-accuro-xv-platform-302917179.html Anatomy segmentation and three-dimensional skeletal visualization arrive with this clearance; an injury detection module for clinical decision support is in development on the platform roadmap CHARLOTTESVILLE, Va., Oct. 22, 2026 -- RIVANNA®, developer of AI-enabled clinical... ———————————————————————————————————————————————————————————— CCC Intelligent Solutions Adds Azimuth to Diagnostics Network 2026-10-22 · GlobeNewswire · SaaS, Medical devices https://www.globenewswire.com/news-release/2026/10/22/3386798/0/en/ccc-intelligent-solutions-adds-azimuth-to-diagnostics-network.html Integration brings Azimuth’s ADAS calibration identification and labor time capabilities into CCC ONE®, helping collision repairers streamline repair planning and estimating Integration brings Azimuth’s ADAS calibration identification and labor time capabilities into CCC ONE®, helping collision repairers streamline repair planning and estimating ———————————————————————————————————————————————————————————— CorWave Completes Enrollment in Feasibility Study and Presents First Clinical Data on Adaptive Support with its Wave Membrane LVAD 2026-10-22 · Business Wire · Healthcare, Biotech & pharma, Medical devices https://finance.yahoo.com/healthcare/articles/corwave-completes-enrollment-feasibility-study-171700231.html CLICHY, France, October 22, 2026--CorWave SA, a clinical-stage medical technology company pioneering innovative cardiac assist devices, announces the completion of enrollment in its feasibility study of the CorWave Left Ventricular Assist System (LVAS). The company also presented the first clinical da ———————————————————————————————————————————————————————————— New Guidelines Support Safety and Benefits of Ultrasound-Enhancing Agents in Cardiology 2026-10-22 · Business Wire · Medical devices https://finance.yahoo.com/healthcare/articles/guidelines-support-safety-benefits-ultrasound-155200608.html CHICAGO & SÃO PAULO, October 22, 2026--Contrast-enhanced ultrasound (CEUS) is "safe, cost-effective and widely-supported by scientific evidence," according to new evidence-based guidelines on the use of microbubble contrast agents in cardiovascular ultrasound published by the Brazilian Society of Cardi ———————————————————————————————————————————————————————————— Las Vegas Dentist on Psychological Impact of Tooth Loss 2026-10-22 · EIN Presswire · Healthcare, Medical devices https://www.einpresswire.com/article/951043039/las-vegas-dentist-on-psychological-impact-of-tooth-loss Dr. Jim Willardsen details how missing teeth can affect self-esteem, and what patients should know about dental implants and other treatment options. LAS VEGAS, NV, UNITED STATES, October 22, 2026 / EINPresswire.com / -- Tooth loss is often discussed in terms of chewing, speech, and bone health, but its emotional and psychological effects can be just as significant. At True Dentistry, Las Vegas implant dentist Jim Wi ———————————————————————————————————————————————————————————— MIMOSA Diagnostics Wins Ontario Centre of Innovation’s 2026 Mind2Market Award for MIMOSA Pro 2026-10-22 · EIN Presswire · Healthcare, Medical devices https://www.einpresswire.com/article/951340015/mimosa-diagnostics-wins-ontario-centre-of-innovation-s-2026-mind2market-award-for-mimosa-pro MIMOSA Diagnostics, maker of the MIMOSA Pro wound and tissue-health imaging device, receives the Ontario Centre of Innovation’s 2026 Mind2Market Award, sponsored by GeoMate. The MIMOSA Pro Device MIMOSA Pro helps clinicians identify early signs of pressure injuries and deep tissue injuries and manage chronic wounds from admission to discharge TORONTO, ON, CANADA, October 22, 2026 / EINPresswire.com / -- Key facts Who ———————————————————————————————————————————————————————————— Companion Diagnostics Market to Grow at 13.39% CAGR, Reaching US$ 30.61 Billion by 2033 2026-10-22 · PR News Releaser · Medical devices https://www.prnewsreleaser.com/news/476931 The Companion Diagnostics Market is covered by Business Market Insights with 2025 as the base year and 2026–2033 as the forecast period. The retrieved public source material for this batch did not expose all three headline values required for a ... Read more ———————————————————————————————————————————————————————————— Biograph Completes First U.S. Study with Caristo Diagnostics’ AI-Powered Coronary Inflammation Detection, Finding Risk in Over 42% of Asymptomatic Patients 2026-10-22 · Business Wire · AI, Healthcare, Medical devices https://finance.yahoo.com/healthcare/articles/biograph-completes-first-u-study-130000817.html The study evaluated whether AI analysis of coronary inflammation in cardiac CT scans can help identify early cardiovascular risk before symptoms or obstructive plaque appear SAN MATEO, Calif. & NEW YORK, October 22, 2026--Biograph , the world's most advanced preventive health and diagnostics clinic, t ———————————————————————————————————————————————————————————— Diabetes Foundation and ShopRite Pharmacy Work to Expand Access to Affordable Diabetes Monitoring Supplies Across New Jersey 2026-10-22 · PRWeb · Food & drink, Medical devices https://www.prweb.com/releases/diabetes-foundation-and-shoprite-pharmacy-work-to-expand-access-to-affordable-diabetes-monitoring-supplies-across-new-jersey-302916644.html Statewide initiative provides no-cost blood glucose monitoring supplies and connects participants with lower-cost replacement supplies at ShopRite pharmacies. MAHWAH, N.J., Oct. 22, 2026 -- The Diabetes Foundation and Wakefern Food Corp., the supermarket cooperative... ———————————————————————————————————————————————————————————— Reality TV Star Cortney Reardanz's Fiancé Gets a Brand-New Smile in 24 Hours at Nuvia Dental Implant Center 2026-10-22 · EIN Presswire · Medical devices https://www.einpresswire.com/article/951281346/reality-tv-star-cortney-reardanz-s-fianc-gets-a-brand-new-smile-in-24-hours-at-nuvia-dental-implant-center Reality Star Cortney Reardanz and Fiance Phil Nuvia's Permanent Zirconia Teeth Prosthetic That Attaches to Full Mouth Dental Implants Cortney Reardanz Fiance Phil Before and After Getting Full Mouth Dental Implants at Nuvia Facing a wedding and online critics, Phil skipped the year-long wait and got permanent zirconia teeth in 24 hours. It's worth the financial expense and a little bit of pain for a couple days to be ———————————————————————————————————————————————————————————— Perimeter Medical Imaging AI to Participate in the Planet MicroCap Showcase in Toronto 2026-10-22 · PR Newswire · AI, Healthcare, Medical devices https://www.prnewswire.com/news-releases/perimeter-medical-imaging-ai-to-participate-in-the-planet-microcap-showcase-in-toronto-302916356.html TORONTO and DALLAS, Oct. 22, 2026 -- Perimeter Medical Imaging AI, Inc. (TSX-V: PINK) (OTCQX: PYNKF) ("Perimeter" or the "Company"), a commercial-stage medical technology company, is pleased to announce that its CEO, Adrian Mendes, will present a Company update regarding... ———————————————————————————————————————————————————————————— USA Peptides: Kylo Peptides Partners With Freedom Diagnostics for Independent Verification of Research Peptides 2026-10-22 · GlobeNewswire · Media, Medical devices https://www.globenewswire.com/news-release/2026/10/22/3386317/0/en/usa-peptides-kylo-peptides-partners-with-freedom-diagnostics-for-independent-verification-of-research-peptides.html Kylo Peptides has engaged Freedom Diagnostics to independently test every lot for identity, purity, and net content. ———————————————————————————————————————————————————————————— Stereotaxis Announces First Robotic Magnetic Navigation System in Latvia 2026-10-22 · GlobeNewswire · Finance, Healthcare, Education, Medical devices https://www.globenewswire.com/news-release/2026/10/22/3386309/21634/en/stereotaxis-announces-first-robotic-magnetic-navigation-system-in-latvia.html ST. LOUIS, Oct. 22, 2026 -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that Pauls Stradiņš Clinical University Hospital in Riga, Latvia, has established the first robotic center for the treatment of cardiac arrhythmias in Latvia and has successfully treated initial patients with the Genesis Robotic Magnetic Navigation System. ———————————————————————————————————————————————————————————— Open MRI Systems Market to Reach US$ 2.6 Billion by 2031, Growing at CAGR of 6.7% from 2025 to 2031 2026-10-22 · PR News Releaser · Medical devices https://www.prnewsreleaser.com/news/476560 The global Open MRI Systems Market was valued at US$ 1.65 Billion in 2024 and is projected to reach US$ 2.6 Billion by 2031, registering a CAGR of 6.7% from 2025 to 2031. The Open MRI Systems Market report provides ... Read more ———————————————————————————————————————————————————————————— RMTG's ISSCA Division Returns to São Paulo for a Second Brazil Congress, November 20-21 2026-10-22 · ACCESS Newswire · Healthcare, Government & policy, Medical devices https://finance.yahoo.com/healthcare/articles/rmtgs-issca-division-returns-o-110100459.html A second Brazil event in a single year - a frequency ISSCA has not previously applied - underscores Brazil's priority alongside Cellgenic's permanent operations there. MIAMI, FL / October 22, 2026 / Regenerative Medical Technology Group, Inc. (the "Company" or "RMTG") (OTCID:RMTG), a Regenerative Medicine Company. operating through its wholly owned subsidiary Global Stem Cells Group, today announced ———————————————————————————————————————————————————————————— BlossomHill Therapeutics Announces Collaboration with Foundation Medicine to Develop First Companion Diagnostic for BH-30643 in EGFR C797S Mutated Non-Small Cell Lung Cancer 2026-10-22 · GlobeNewswire · Finance, Healthcare, Biotech & pharma, Medical devices https://www.globenewswire.com/news-release/2026/10/22/3386178/0/en/blossomhill-therapeutics-announces-collaboration-with-foundation-medicine-to-develop-first-companion-diagnostic-for-bh-30643-in-egfr-c797s-mutated-non-small-cell-lung-cancer.html SAN DIEGO, Oct. 22, 2026 -- BlossomHill Therapeutics, Inc. (Nasdaq: BLSM), a clinical-stage biopharmaceutical company applying an intentional, chemistry-based approach to design and develop innovative small molecule medicines for the treatment of cancer, today announced a collaboration with Foundation Medicine, Inc. to develop a companion diagnostic assay (CDx) for the EGFR C797S resistance mutation. The collaboration will leverage the ongoing Phase 1/2 SOLARA clinical trial evaluating BH-30643 in the targeted treatment of epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC) patients to validate the assay. ———————————————————————————————————————————————————————————— Antogen Opens Oklahoma City Laboratory, Expands Commercial Operations 2026-10-22 · Business Wire · Biotech & pharma, Medical devices https://finance.yahoo.com/healthcare/articles/antogen-opens-oklahoma-city-laboratory-110000708.html OKLAHOMA CITY, October 22, 2026--Antogen, Inc., a biotechnology company pioneering next-generation personalized diagnostics through immunopeptidomics, today announced that its new laboratory in Oklahoma City is fully operational and processing customer samples. This marks a significant milestone in Ant ———————————————————————————————————————————————————————————— Biodesix to Report Third Quarter 2026 Financial Results on November 5, 2026 2026-10-22 · PressReach · Finance, Medical devices https://pressreach.com/biodesix-to-report-third-quarter-2026-financial-results-on-november-5-2026 LOUISVILLE, Colo., Oct. 22, 2026 — Biodesix, Inc. (Nasdaq: BDSX), a leading diagnostic solutions company, today announced that it will release financial results for the third quarter ended September 30, 2026 after the close of trading on Thursday, November 5. Biodesix management will host a conference call and webcast to discuss its financial … Continue reading "Biodesix to Report Third Quarter 2026 Financial Results on November 5, 2026" ———————————————————————————————————————————————————————————— UAE fast-tracking advanced diagnostics as global market heads for US$152 billion 2026-10-22 · EIN Presswire · Healthcare, Medical devices https://www.einpresswire.com/article/951458175/uae-fast-tracking-advanced-diagnostics-as-global-market-heads-for-us-152-billion Mohini Mehta, Senior Consultant, Healthcare & Life Sciences, Frost & Sullivan Solenne Singer, Senior Vice President - Healthcare, inD WHX 2026 Labs Zone at WHX 2027 will connect global suppliers to the Middle East’s growing US$5.4 billion diagnostics market The next frontier in diagnostics will not be defined by who adopts the most advanced technology first, but by who can integrate it into clinical practice at scale ———————————————————————————————————————————————————————————— TA to Invest in MedEnvision in Partnership With Its Founders, Management and Smile Invest 2026-10-22 · Business Wire · Medical devices https://finance.yahoo.com/healthcare/articles/ta-invest-medenvision-partnership-founders-051600510.html LONDON, October 22, 2026--MedEnvision ( www.medenvision.com ), a Belgian medtech company that helps orthopaedic surgical teams work more efficiently in the operating theatre, announces, together with its founders, management and current financial partner Smile Invest, a new strategic partnership with T ———————————————————————————————————————————————————————————— [Ad hoc announcement pursuant to Art. 53 LR] Roche continues strong momentum in the third quarter with sales growth of +7% at constant exchange rates (CER) and +8% in CHF; Group sales increase +6% (CER), +1% in CHF, in the first nine months of 2026 2026-10-22 · Roche · Finance, AI, SaaS, Healthcare, Real estate, Automotive, Food & drink, Industrial, Biotech & pharma, Sustainability, Investing & markets, Legal, Government & policy, Jobs & workplace, Marketing & advertising, Software & IT, Medical devices https://www.roche.com/media/releases/med-cor-2026-10-22 Ad hoc announcement pursuant to Art. 53 LR Basel, 22 October 2026 Roche continues strong momentum in the third quarter with sales growth of +7% at constant exchange rates (CER) and +8% in CHF; Group sales increase +6% (CER), +1% in CHF, in the first nine months of 2026 Group sales were +6% at constant exchange rates (CER)1, +1% when reported in CHF and +7% in USD2, in the first nine months of 2026, driven by high demand for our innovative medicines and diagnostics. In the third quarter, sales grew +7% (CER) and +8% in CHF (+7% in USD), as exchange rates stabilised. Pharmaceuticals Division sales were +7% at CER, +2% when reported in CHF and +8% in USD, in the first nine months, due to continued high demand for medicines to treat severe diseases; Xolair (chronic hives, food allergies), Hemlibra (haemophilia A), Ocrevus (multiple sclerosis), Phesgo (breast cancer) and Vabysmo (severe eye diseases) were the top growth drivers. Diagnostics Division sales were +4% at CER, stable when reported in CHF and +6% in USD, in the first nine months, as demand for core lab and pathology solutions more than offset the impact of healthcare pricing reforms in China. Highlights: US approval for Tecentriq for the adjuvant treatment of stage-III DNA mismatch repair colon cancer, Gazyva/Gazyvaro for reducing the risk of relapse in patients 2 years of age and older with frequently relapsing or steroid-dependent childhood-onset idiopathic nephrotic syndrome and Enspryng in thyroid eye disease US Priority Reviews for fenebrutinib in both relapsing and primary progressive multiple sclerosis and Enspryng in MOGAD, an autoimmune disease; vamikibart filing acceptance in uveitic macular edema, a leading cause of vision loss EU approval for Susvimo in neovascular age-related macular degeneration (nAMD), a severe eye disease, and Ocrevus in paediatric relapsing multiple sclerosis; EMA validation of application for Enspryng in MOGAD in Europe Positive data for: sefaxersen in an autoimmune condition affecting kidney function (phase III), Lunsumio in blood cancer (phase III), Tam-Peli in relapsed small-cell lung cancer (phase III) as well as enicepatide and petrelintide in overweight or obesity and type 2 diabetes (both phase II) US clearance for Elecsys pTau217 test, providing clinicians across primary and specialty care with a single-biomarker blood test to aid in identifying amyloid pathology associated with Alzheimer’s disease Launch of two new, real-time PCR tests to support public health epidemic response to the US outbreak of the Cyclospora cayetanensis parasite Delivery of molecular tests to support the Democratic Republic of the Congo health ministry-led response to the Ebola outbreak Manufacturing and R&D capacity expansion: Hillsboro injectable medicines facility and Innovation Center Boston for cardiovascular, renal and metabolic diseases in the US and small molecules facility in Basel, Switzerland Outlook for 2026 confirmed Roche CEO Thomas Schinecker: “In the third quarter, we delivered strong sales growth of +7% at constant exchange rates and +8% in Swiss francs. Most importantly, we continued to make meaningful progress for patients. We advanced another five potential new medicines into the final stage of development this year and now aim to bring up to 20 new medicines to patients by 2030. The US FDA granted Priority Review for fenebrutinib in both relapsing and primary progressive multiple sclerosis, bringing us closer to delivering the first high-efficacy, brain-penetrant oral therapy to patients. Giredestrant is also under FDA Priority Review in both early-stage and advanced breast cancer, and we are fully prepared to launch later this year, pending approval. In Diagnostics, we received US FDA clearance for Elecsys pTau217, the first and only FDA-cleared single-biomarker blood test for Alzheimer’s disease that supports both rule-in and rule-out assessment of amyloid pathology across primary and specialty care settings.  We confirm our full-year outlook.” Outlook for 2026 Roche (SIX: RO, ROP; OTCQX: RHHBY) expects an increase in Group sales in the mid single digit range (CER) for 2026. Core earnings per share are targeted to develop in the high single digit range (CER). Roche expects to further increase its dividend in Swiss francs. SalesCHF millionsAs % of sales% change January–September 2026202520262025At CERIn CHFIn USD Group 46,49345,862100.0100.0+6+1+7          Pharmaceuticals Division36,21235,55577.977.5+7+2+8 United States18,71218,79840.241.0+50  Europe6,8196,81814.714.9+20  Japan2,3522,1395.14.7+25+10  International8,3297,80017.916.9+10+7           Diagnostics Division10,28110,30722.122.5+40+6 International: Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others Group sales In the first nine months of 2026, Roche sales were +6% at CER, +1% when reported in CHF, to CHF 46.5 billion due to strong demand for pharmaceutical products and diagnostic solutions. The appreciation of the Swiss franc against most currencies, notably the US dollar, had a significant impact on the results reported in Swiss francs compared to constant exchange rates. This currency impact reversed in the third quarter. Sales growth in the Pharmaceuticals Division was +7% at CER, +2% when reported in CHF, to CHF 36.2 billion, with medicines for severe diseases continuing their strong growth. The top five growth drivers – Xolair, Hemlibra, Ocrevus, Phesgo and Vabysmo – achieved total sales of CHF 16.8 billion, an increase of +12% at CER, or +6% in CHF, compared to the first nine months of 2025. Sales of products with expired patents (Avastin, Herceptin, MabThera/Rituxan, Lucentis and Actemra/RoActemra) decreased by a combined CHF 0.4 billion at CER, or CHF 0.6 billion in CHF. In the United States, sales were +5% at CER, stable when reported in CHF, due to continued growth of Xolair, Hemlibra, Ocrevus, Polivy (blood cancer) and Tecentriq (cancer immunotherapy). This growth more than compensated for the lower sales of Kadcyla (breast cancer) and Perjeta (breast cancer). Sales in Europe were +2% at CER, stable when reported in CHF, as the growing demand for Ocrevus, Phesgo and Evrysdi (spinal muscular atrophy) more than offset the impact of biosimilar competition on Actemra/RoActemra and the conversion to Phesgo on Perjeta. In Japan, sales were +25% at CER, +10% when reported in CHF, mainly due to product supply to third parties and continued growth of Lunsumio (blood cancer), Hemlibra, Polivy, Elevidys (Duchenne muscular dystrophy) and Vabysmo. There was also a positive impact of timing effects related to the implementation of a new enterprise resource planning (ERP) system. Sales in the International region were +10% at CER, +7% when reported in CHF, led by higher sales of Phesgo, Vabysmo, Hemlibra, Ocrevus and Evrysdi. In China, sales were stable at CER and when reported in CHF, driven by continued growth of Phesgo, Vabysmo, Alecensa and Polivy. The increase was partially offset by lower sales of Perjeta due to the conversion to Phesgo and Xofluza due to a milder flu season in 2025. The Diagnostics Division’s sales were +4% at CER, stable when reported in CHF, to CHF 10.3 billion as growth in demand for core lab and pathology solutions more than offset the impact of healthcare pricing reforms in China. Sales in the Europe, Middle East and Africa (EMEA) region were +3% at CER, unchanged when reported in CHF, driven by higher sales of clinical chemistry and immunodiagnostic products. In North America, sales were +9% at CER, +3% when reported in CHF, with growth across the Core Lab, Pathology Lab and Molecular Lab customer areas. Sales in Asia-Pacific were -4% at CER, or -8% when reported in CHF, due to the healthcare pricing reforms in China. In Latin America, sales growth was +12% at CER, or +11% when reported in CHF. Pharmaceuticals: key developments CompoundMilestone Regulatory Enspryng Thyroid eye diseaseFDA approves Enspryng, a first-in-class IL-6R inhibitor, as the first and only at-home subcutaneous treatment option for thyroid eye disease (TED) FDA approval based on phase III SatraGO-1 and -2 studies, with SatraGO-2 demonstrating a significant reduction in eye bulging (proptosis) and improvement in diplopia (double vision), with a favourable safety profile, regardless of TED activity or duration. Enspryng (satralizumab) represents an important advance for people with TED, offering the first at-home subcutaneous treatment option every four weeks during maintenance phase, allowing for greater flexibility in how treatment is administered. Enspryng is an anti-IL-6R monoclonal antibody using novel recycling antibody technology designed to inhibit IL-6 signalling upstream of autoantibody-driven pathology. TED is a rare autoimmune disease affecting approximately 155 out of every 100,000 people in the US that can lead to facial disfigurement and vision-threatening complications if left untreated. More information: Media Release, 16 October 2026 Tecentriq Different types of cancerFDA approves Tecentriq in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of a certain type of stage III colon cancer The approval is based on results from the landmark phase III ATOMIC study, published in The New England Journal of Medicine, which showed Tecentriq plus chemotherapy reduced the risk of disease recurrence or death by 50% compared to chemotherapy alone. It is the first approved adjuvant immunotherapy regimen for stage III dMMR colon cancer, positioning Tecentriq as a new post-surgery standard of care. Nearly 25% of all colon cancers are diagnosed at stage III, and almost one in three patients with stage III colon cancer experience a recurrence within five years. Approval marks the twelfth indication for Tecentriq in the US. More information: Media Release, 9 October 2026 Fenebrutinib Multiple sclerosisFenebrutinib is the first BTK inhibitor to receive US FDA filing acceptance in both relapsing and primary progressive multiple sclerosis Fenebrutinib cut relapses by 51% and 58% vs teriflunomide in phase III RMS trials (FENhance 1 and 2) while showing a consistent, positive trend in delaying disability. Fenebrutinib became the first investigational medicine in more than a decade to slow disability progression in a phase III PPMS trial (FENtrepid), with numerical benefit vs Ocrevus. Fenebrutinib is designed to address two drivers of MS – acute inflammation causing relapses and chronic brain inflammation driving disability progression. If approved, fenebrutinib would become the first BTK inhibitor and first high-efficacy oral treatment for both RMS and PPMS, offering a new option for the nearly 1 million people living with MS in the US. More information: Media Release, 30 September 2026 Susvimo Severe eye diseasesEuropean Commission approves Susvimo for the treatment of neovascular age-related macular degeneration   By continuously delivering medicine into the eye through the Contivue refillable implant, Susvimo is the first and only continuous delivery treatment that offers an alternative to standard-of-care eye injections for nAMD. Susvimo helps people with nAMD maintain their vision with as few as two treatments per year. Data from the phase III Archway study showed that Susvimo maintained vision equivalent to monthly intravitreal ranibizumab injections. nAMD is a leading cause of vision loss in adults over 60 and affects approximately 1.7 million people across the European Union. More information: Media Release, 21 September 2026 Enspryng MOGADFDA grants Priority Review for Enspryng for MOGAD, an autoimmune disease with no approved treatments If approved, Enspryng would be the first and only disease-modifying therapy for MOGAD (myelin oligodendrocyte glycoprotein antibody-associated disease). The filing acceptance is based on the phase III METEOROID study showing that Enspryng reduced the risk of relapses by 68%. The European Medicines Agency (EMA) has validated the application for Enspryng for MOGAD in Europe, with a decision expected in Q3 2027. More information: Media Release, 10 September 2026 Phase III, pivotal and other key read-outs Sefaxersen IgA nephropathyPositive interim data shows sefaxersen significantly reduces proteinuria in people with IgA nephropathy (IgAN) In the phase III IMAgINATION study, sefaxersen demonstrated statistically significant and clinically meaningful reductions in proteinuria versus placebo at 37 weeks, showing best-in-class potential. Sefaxersen inhibits complement factor B production at its primary source in the liver, thus blocking a key driver of IgAN-related kidney damage. Interim data will be presented at an upcoming medical meeting and shared with health authorities. More information: Media Release, 23 September 2026 Enicepatide ObesityRoche announces positive phase II results for dual GLP-1/GIP receptor agonist enicepatide in people living with type 2 diabetes and overweight or obesity At the highest dose (24 mg), enicepatide achieved a mean HbA1c reduction of 2.65% at 48 weeks, highlighting its potential for best-in-disease glycaemic control. By week 48, 90% of patients in the 24 mg enicepatide arm met the type-2-diabetes glycaemic target of ≤6.5% HbA1c, while 62% achieved normoglycaemia (HbA1c <5.7%). At the highest 24 mg dose, enicepatide achieved a mean weight loss of 15.5% at 48 weeks, without a weight loss plateau. More information: Media Release, 22 September 2026 Lunsumio Blood cancerRegimen based on Lunsumio significantly improves progression-free survival in follicular lymphoma in phase III CELESTIMO study Phase III CELESTIMO study met its primary endpoint at the interim analysis demonstrating a statistically significant and clinically meaningful reduction in the risk of disease progression in people with follicular lymphoma who have received at least one prior line of treatment. Data reinforce the potential of this regimen based on Lunsumio to improve clinical outcomes, while offering a tolerable safety profile, a simple dosing schedule and outpatient administration. CELESTIMO is the confirmatory study required to convert the accelerated approval / conditional marketing authorisation of Lunsumio monotherapy for third-line or later (3L+) follicular lymphoma to full approval, as well as to secure an indication in second-line or later (2L+) follicular lymphoma. Data will be submitted to health authorities and presented at an upcoming medical meeting. More information: Media Release, 17 September 2026 Tam-Peli Lung cancerRoche’s collaborator MediLink announces phase III data for Tam-Peli showing significantly improved overall survival in Chinese patient population with relapsed small-cell lung cancer Tambotatug pelitecan (Tam-Peli) demonstrated statistically significant efficacy over topotecan in a phase III study conducted in China, reducing the risk of death by 54% and disease progression by 71%, while achieving an objective response rate of 59.1% vs 9.7%. The novel B7-H3-targeted antibody-drug conjugate with a dual release mechanism of the payload is based on MediLink’s proprietary TMALIN platform, designed to maximise antitumour activity while minimising off-target toxicity. Roche is developing and commercialising Tam-Peli outside mainland China, Hong Kong and Macau across multiple tumour types, with plans to rapidly initiate global trials. Tam-Peli has received US FDA and China CDE Breakthrough Therapy Designations for relapsed small-cell lung cancer. More information: Media Release, 13 September 2026 Vabysmo Severe eye diseasesVabysmo demonstrates sustained two-year results in a difficult-to-treat form of nAMD The SALWEEN study showed significant improvements in vision and retinal health. More than 60% of Asian patients with polypoidal choroidal vasculopathy (PCV), an aggressive subtype of nAMD, treated with Vabysmo showed no signs of polypoidal lesions. By the end of year two, more than 60% of patients were on an extended 20-week treatment interval, reducing treatment burden. More information: Media Release, 28 August 2026 Other ESMO presentation Lung and breast cancer portfolio Roche to present pivotal data at ESMO 2026, showcasing advances across its lung and breast cancer late-stage portfolio Phase III Krascendo 1 results demonstrated divarasib’s superiority over current standard-of-care, first-generation KRAS G12C inhibitors in previously treated advanced G12C-mutated non-small cell lung cancer. Patient-reported outcomes from phase III lidERA study showed that improved efficacy of giredestrant over standard endocrine therapy is achieved without compromising tolerability and health-related quality of life in early-stage breast cancer. Phase III results in Chinese patients with metastatic nasopharyngeal carcinoma demonstrate the potential of Tam-Peli, a next-generation B7-H3-targeted ADC, to deliver robust efficacy with a favourable safety profile in high-unmet-need solid tumours.   More information: Media Release, 19 October 2026 Vamikibart Uveitic macular edemaRoche presents new phase III one-year data for vamikibart in uveitic macular edema (UME), a serious cause of vision loss In the MEERKAT and SANDCAT studies, vamikibart demonstrated sustained improvements in vision and reductions in macular thickness in patients with UME at 52 weeks. UME is the leading cause of moderate and severe vision loss in patients with uveitis, posing a significant risk of blindness if left untreated. The FDA has accepted Roche’s Biologics License Application (BLA), with an approval decision expected by July 2027. More information: Media Release, 10 October 2026 Vabysmo Severe eye diseasesRoche presents new data at EURETINA, highlighting the real-world effectiveness and safety of Vabysmo across major retinal conditions New real-world results for Vabysmo in nAMD, diabetic macular edema and retinal vein occlusion reinforce robust effectiveness and durability across previously untreated and treated eyes, with no new safety signals. Advanced AI-enabled analysis of imaging confirms rapid and meaningful anatomical drying supporting Vabysmo as a standard-of-care therapy in routine clinical care. With more than 5,000 patients enrolled, VOYAGER is the largest, prospective, non-interventional real-world dataset evaluating Vabysmo across diverse clinical practice settings worldwide.   More information: Media Release, 1 October 2026 Giredestrant Breast cancerGiredestrant combination significantly improved progression-free survival in ER-positive advanced breast cancer in phase III evERA data published in The New England Journal of Medicine Giredestrant plus everolimus reduced the risk of disease progression or death by 44% and 62% in ITT and ESR1-mutated populations, respectively, versus standard endocrine therapy plus everolimus. By targeting resistance to endocrine treatments, the giredestrant combination seeks to delay disease progression and improve overall patient outcomes. The FDA has set a PDUFA goal date for giredestrant in early-stage breast cancer of 30 November 2026 and in advanced disease of 18 December 2026. More information: Media Release, 1 October 2026 Board of Directors nominationRoche proposes Dr Christophe Weber, former CEO of Takeda Pharmaceuticals, for election to its Board of Directors at the 2027 Annual General Meeting Roche’s Board of Directors has approved to propose Dr Christophe Weber, former CEO of Takeda Pharmaceuticals, for election to the Board at the Annual General Meeting on 9 March 2027. Roche Chairman Severin Schwan highlighted Dr Weber’s extensive healthcare industry knowledge and leadership experience as valuable assets for the Board. Roche continues its commitment to transformative medicines and diagnostics, focusing on major disease areas and global healthcare challenges. More information: Media Release, 23 September 2026 Innovation Center BostonRoche announces grand opening of its Innovation Center Boston to drive advancements in cardiovascular, renal and metabolic diseases The centre will be a hub for Roche and Genentech, bringing together expertise in cardiovascular, renal and metabolic diseases, as well as for data science and AI specialists to drive innovation in drug discovery and development. It will expand Roche’s and Genentech’s presence in Boston, reflecting a long-term commitment to one of the world’s leading life sciences hubs. This is part of Roche and Genentech’s USD 50 billion investment in US manufacturing and R&D, building on recent investments and manufacturing milestones in Holly Springs, North Carolina, and Hillsboro, Oregon. More information: Media Release, 17 September 2026 Hillsboro facilityGenentech, Roche’s US subsidiary, announces a USD 750 million manufacturing expansion in Hillsboro, Oregon The new facility in Hillsboro, Oregon for the assembly of injectable medicines and delivery devices will further advance end-to-end US drug manufacturing capabilities. Approximately USD 750 million investment will double the size of the existing facility and is expected to create an additional 250 specialised manufacturing jobs. Flexible manufacturing capacity will support advanced drug delivery devices that can provide patients with more convenient ways to receive treatment. More information: Media Release, 20 August 2026 Pharmaceuticals sales SalesCHF millionsAs % of sales% change January–September2026202520262025At CERIn CHF Pharmaceuticals Division36,21235,555100.0100.0+7+2 United States18,71218,79851.752.9+50 Europe6,8196,81818.819.2+20 Japan2,3522,1396.56.0+25+10 International8,3297,80023.021.9+10+7 International: Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others Top 20 best-selling pharmaceuticals (% change at CER1)TotalUnited StatesEuropeJapanInternational CHF m%CHF m%CHF m%CHF m%CHF m% Ocrevus Multiple sclerosis5,317+73,581+51,136+9--600+21 Hemlibra Haemophilia A3,750+122,006+9769+5291+20684+23 Vabysmo Eye diseases (nAMD, DME, RVO)3,196+102,060+2585+7131+41420+65 Tecentriq Cancer immunotherapy2,615+51,243+8626-2245+6501+9 Xolair3 Chronic hives, food allergies2,521+202,521+20------ Phesgo Breast cancer2,064+18486-1657+11152+24769+43 Perjeta3 Breast cancer2,040-8824-10361-1338-20817-3 Actemra/RoActemra3 RA, COVID-191,621-10795-9328-26232+14266-4 Evrysdi Spinal muscular atrophy1,470+18497+12504+1465+7404+33 Kadcyla3 Breast cancer1,339-9442-19370-565+9462-2 Polivy Blood cancer1,302+24606+29204-9176+30316+44 Alecensa Lung cancer1,213+6391-1189-3154+15479+15 MabThera/Rituxan3 Blood cancer, RA919+3605+1294-88-16212-10 Activase/TNKase3 Cardiac diseases830+6792+5----38+12 Gazyva/Gazyvaro3 Blood cancer, lupus nephritis751+7369+4176-228+28178+25 Herceptin3 Breast and gastric cancer695-12140-15205-63-35347-13 Avastin3 Various cancer types639-12195-856+556-43332-9 Columvi Blood cancer327+67146+2492+113--89+167 Enspryng Acute inflammation of brain, spinal cord and optic nerves319+2879+1834+18138+3068+42 Pulmozyme3 Cystic fibrosis303-12214-1143-111+3845-18 DME: diabetic macular edema / nAMD: neovascular or ‘wet’ age-related macular degeneration / RVO: retinal vein occlusion / RA: rheumatoid arthritis Diagnostics key developments ProductMilestone Elecsys pTau217 Alzheimer’s diseaseRoche receives FDA clearance for Elecsys pTau217, advancing Alzheimer’s disease assessment across primary and specialty care It is the first and only FDA-cleared, single-biomarker blood test supporting both rule-in and rule-out assessment of amyloid pathology across primary and specialty care settings. The test delivers consistency across clinical settings by using the same validated cut-offs in primary and specialty care. It is designed for broad implementation across Roche’s installed base of more than 4,500 cobas laboratory instruments in the US supporting access through existing laboratory infrastructure.   More information: Investor Update, 24 August 2026 Diagnostics sales SalesCHF millionsAs % of sales% change January–September2026202520262025At CERIn CHF Diagnostics Division10,28110,307100.0100.0+40 Customer areas       Core Lab5,7555,68856.055.2+5+1 Molecular Lab1,8361,86117.918.1+3-1 Near Patient Care1,3481,47713.114.3-5-9 Pathology Lab1,3421,28113.012.4+10+5 Regions       Europe, Middle East, Africa3,6983,68636.035.8+30 North America3,3893,30532.932.1+9+3 Asia-Pacific2,3432,54722.824.7-4-8 Latin America8517698.37.4+12+11 More information on Roche’s performance in the first nine months of 2026: 9M 2026 presentation Appendix with tables  About Roche Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions. Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceuticals Divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them. Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law. References [1] CER (Constant Exchange Rates). The percentage changes at constant exchange rates are calculated using simulations by reconsolidating both the 2026 and 2025 results at constant exchange rates (the average rates for the year ended 31 December 2025). For the definition of CER, see page 178 of the Roche Finance Report 2025. [2] USD (US dollars). The percentage changes for selected sales figures at US dollars are calculated by translating both the 2026 and 2025 sales figures at the respective average US dollar exchange rate for the period in question. This supplementary information is provided to assist readers when assessing comparability with other companies. [3] Products launched before 2015. Cautionary statement regarding forward-looking statements This document contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this document, such as: (1) pricing and product initiatives of competitors; (2) legislative and regulatory developments and economic conditions; (3) delay or inability in obtaining regulatory approvals or bringing products to market; (4) fluctuations in currency exchange rates and general financial market conditions; (5) uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side effects of pipeline or marketed products; (6) increased government pricing pressures; (7) interruptions in production; (8) loss of or inability to obtain adequate protection for intellectual property rights; (9) litigation; (10) loss of key executives or other employees; and (11) adverse publicity and news coverage. The statement regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche’s earnings or earnings per share for this or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche. Roche Global Media Relations Phone: +41 61 688 88 88 / e-mail: media.relations@roche.com Tristan Schmitz Phone: +41 79 529 70 35Lorena Corfas Phone: +41 79 568 24 95 Simon Goldsborough Phone: +44 797 32 72 915Karsten Kleine Phone: +41 79 461 86 83 Kirti Pandey Phone: +41 79 398 38 53Yvette Petillon Phone: +41 79 961 92 50 Irène Stephan Phone: +41 79 377 83 75Albert Thottiyil Phone: +41 79 775 66 12 Roche Investor Relations Dr Bruno Eschli Phone: +41 61 687 5 284 e-mail: bruno.eschli@roche.comDr Sabine Borngräber Phone: +41 61 688 80 27 e-mail: sabine.borngraeber@roche.com Dr Birgit Masjost Phone: +41 61 688 48 14 e-mail: birgit.masjost@roche.com  Investor Relations North America Loren Kalm Phone: +1 650 225 3217 e-mail: kalm.loren@gene.com   Attachments Communications appendix tables_YTD Sep 2026_Sales_02102026 Media Investor Release Roche Q3 2026 English ———————————————————————————————————————————————————————————— Brain Implants Market Size, Share and Forecast to US$ 6.26 Billion by 2033 2026-10-22 · PR News Releaser · Medical devices https://www.prnewsreleaser.com/news/475814 The Brain Implants Market size was valued at US$ 2.55 billion in 2025 and is projected to reach US$ 6.26 billion by 2033, growing at a CAGR of 11.88% during 2026–2033. Market growth is best understood as the interaction between ... Read more ———————————————————————————————————————————————————————————— Global Market Forecast for Real-Time Follicle Counting AI Ultrasound Probes to Exceed $0.91 Billion by 2030 2026-10-22 · EIN Presswire · AI, Medical devices https://www.einpresswire.com/article/950108185/global-market-forecast-for-real-time-follicle-counting-ai-ultrasound-probes-to-exceed-0-91-billion-by-2030 The Business Research Company Real-Time Follicle Counting AI Ultrasound Probe Market Overview The Business Research Company's Global Market Forecast for Real-Time Follicle Counting AI Ultrasound Probes to Exceed $0.91 Billion by 2030 Expected to grow to $0.91 billion in 2030 at a compound annual growth rate (CAGR) of 13.3%” — The Business Research Company LONDON, GREATER LONDON, UNITED KINGDOM, October 22, 2026 / EIN ———————————————————————————————————————————————————————————— Roche presents new pivotal trial data across broad neuroimmunology portfolio at MSToronto2026 2026-10-21 · Roche · Healthcare, Automotive, Travel, Biotech & pharma, Sustainability, Government & policy, Medical devices, Chemicals & materials https://www.roche.com/media/releases/med-cor-2026-10-21 Fenebrutinib FENtrepid and FENhance 1 & 2 late-breaking data demonstrate a therapeutic effect on chronic active lesions, addressing a primary driver of long-term disability progression in multiple sclerosis (MS) Fenebrutinib FENhance 1 & 2 Phase III pooled data show a 55% reduction in annualised relapse rate (ARR) vs active comparator Following European Commission paediatric approval on 15 October, new Ocrevus OPERETTA 2 Phase III data show 90% of children aged 10–17 remained relapse-free over two years Featured in "Best of MSToronto2026", Enspryng METEOROID Phase III data highlight significant attack reduction and improved functional recovery in MOGAD, an underserved autoimmune disease Basel, 21 October 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today new Phase III data for investigational fenebrutinib in multiple sclerosis (MS), demonstrating reduced markers of chronic brain inflammation as well as more comprehensive disease control versus active comparators.1-3 These findings, alongside new Ocrevus® (ocrelizumab) and Enspryng® (satralizumab) data, will be featured across more than 40 abstracts at MSToronto2026 (10th ACTRIMS- ECTRIMS Meeting), held 21 to 23 October in Toronto. Highlights include a fenebrutinib late-breaking presentation and an Enspryng presentation in the “Best of MSToronto2026.4 “Addressing long-term disability progression to preserve people’s independence remains a critical challenge in neuroinflammatory diseases, and particularly in multiple sclerosis,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Our recent data indicate that fenebrutinib can inhibit disease activity inside and outside the central nervous system, underscoring its potential to transform care for people living with relapsing and primary progressive forms of multiple sclerosis.” Fenebrutinib targets progressive biology inside the brain New data from the pivotal trials in RMS (FENhance 1 and 2) and PPMS (FENtrepid) support the potential of fenebrutinib as the first and only high-efficacy oral medicine for both forms of MS. Reduction of chronic active lesions (Late-breaking oral #O137): In the first prospective demonstration of a therapeutic effect on chronic active lesions in MS Phase III clinical trials, data show fenebrutinib reduced the volume of slowly expanding lesions (SELs) by up to 30% (p<0.001) in RMS (over 96 weeks) and PPMS (over 120 weeks), along with a 62% (p=0.001) reduction in accumulation of paramagnetic rim lesions (PRLs) in RMS, versus active comparators. These findings demonstrate that fenebrutinib directly targets chronic neuroinflammation in the brain, a primary driver of disability progression in MS.1 Comprehensive disease control (Poster #P1434): In the pooled RMS trials, three quarters (75%) of fenebrutinib-treated patients showed no evidence of disease activity (NEDA-3) meaning zero relapses, zero MRI activity and zero worsening disability at nearly two years, a 70% reduction (p<0.001) versus the comparator. These results show fenebrutinib’s potential to suppress disease activity and delay progression.2 Preserving brain volume and function (Oral #O089): Pooled RMS data show fenebrutinib reduced the annualised relapse rate (ARR) by 55% versus the comparator (p<0.001) over 96 weeks. In addition, fenebrutinib reduced annual total brain volume loss by 23% (p<0.001) and 12-week composite confirmed disability progression by 16% (p=0.04). These findings demonstrate fenebrutinib’s potential to control relapses, to slow brain tissue loss caused by neuronal cell death and to preserve function.3 Ocrevus provides consistent benefits across all age groups New data show that Ocrevus provides significant and consistent efficacy across a broad MS patient population, from children 10 years of age to older adults. Two-year data and immune function in paediatric MS (3 posters on the Phase III OPERETTA 2 study): 90% of children with relapsing-remitting MS (RRMS) treated with Ocrevus, who were 10-17 years old at trial entry, remained free of relapses over two years (#P1439).5 Ocrevus selectively depleted target B cells with little to no effect on other immune cells (#P1407), while preserving pre-existing immunity to common childhood vaccines in 81–100% of patients (#P1415). The European Commission approved Ocrevus in this indication on 15 October, following FDA approval in May.6,7 Two-year data in patients >55 years old (Poster #P1426 on the Phase IIIb CONSONANCE study): 53% of participants over 55 years old treated with Ocrevus showed no disability progression after two years, similarly to younger participants (55%), showing Ocrevus maintains its effect on progression as people age.8 Switching from other treatments to Ocrevus: Real-world data show progression was the leading reason for patients switching from ofatumumab to Ocrevus (ePoster #EP2733).9 A separate analysis of patients treated with Ocrevus or ofatumumab for one year show Ocrevus was associated with lower MRI lesion activity (Poster #P0305).10 Enspryng reduces risk of attack and is associated with improved recovery Exploratory analyses of the pivotal METEOROID trial suggest that in addition to significantly lowering the risk of relapse (AAN 2026), Enspryng was associated with improved recovery and reduced disability progression, which is critical to prevent permanent damage to the optic nerves, spinal cord or brain in myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). These findings reinforce Enspryng’s potential to become the first FDA-approved treatment for MOGAD, with a decision in the U.S. expected in January 2027.4,11 Relapse recovery (Oral #O035): Patients treated with Enspryng achieved numerically superior recovery at 12 weeks post relapse versus placebo (median change in Expanded Disability Status Scale [EDSS] of -2 vs -0.5). Overall function was stable (median 0) with Enspryng, compared to worsening (median 0.5) with placebo, as measured with the EDSS at the end of the double-blind period or first relapse.4  About fenebrutinib Fenebrutinib is an investigational oral, central nervous system (CNS)-penetrant, reversible and non-covalent Bruton’s tyrosine kinase (BTK) inhibitor with an optimised pharmacokinetics (PK) profile. Fenebrutinib can act throughout the body and also cross the blood-brain barrier into the CNS to target chronic inflammation. It is uniquely designed to target relapsing and progressive biology by inhibiting cells in the immune system known as B cells and microglia. Targeting B cells helps control the acute inflammation that causes relapses, while targeting microglia inside the brain addresses the chronic damage that is thought to drive long-term disability progression. While most current BTK inhibitors are covalent and irreversible, meaning they form a permanent chemical bond with the enzyme, fenebrutinib is non-covalent and reversible, meaning it binds and then eventually releases the enzyme. About Ocrevus® (ocrelizumab) Ocrevus is a humanised monoclonal antibody designed to target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage. Ocrevus IV and Ocrevus subcutaneous (SC; marketed as Ocrevus Zunovo® [ocrelizumab hyaluronidase-ocsq] in the U.S.) are the only therapies approved for both RMS (including relapsing-remitting multiple sclerosis [RRMS] and active, secondary progressive multiple sclerosis [SPMS], as well as clinically isolated syndrome [CIS] in the U.S.) and primary progressive multiple sclerosis (PPMS). Both Ocrevus IV and SC are administered every six months. The initial IV dose is given as two 300 mg infusions two weeks apart with subsequent doses given as single 600 mg infusions. Ocrevus SC is given as a single 920 mg subcutaneous injection every six months. About Enspryng® (satralizumab) Enspryng, developed by Chugai, a member of the Roche Group, is a humanised monoclonal antibody that binds to both soluble and membrane-bound interleukin-6 receptors (IL-6R), thereby inhibiting IL-6 mediated signalling, a key pathway involved in inflammation. Enspryng incorporates Chugai’s proprietary antibody recycling technology, which enables pH-dependent binding to IL-6R and repeated engagement of the target, extending antibody circulation and supporting sustained inhibition of IL-6 mediated signalling. Enspryng is the first and only IL-6R inhibitor treatment currently approved in approximately 90 countries for neuromyelitis optica spectrum disorder (NMOSD), including in the U.S. and E.U., with a well-established safety profile in over 16,000 patients. Enspryng was also recently approved for the treatment of thyroid eye disease (TED) in the U.S. Roche is committed to developing Enspryng in additional neurological autoimmune and inflammatory diseases that may benefit from inhibition of IL-6 mediated signalling, including myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) and autoimmune encephalitis (AIE). About Roche in Neurology Neurology is a major focus of research and development at Roche. Our goal is to pursue groundbreaking science to develop new diagnostics and treatments that help improve the lives of people with chronic and potentially devastating diseases globally. Roche is investigating more than a dozen medicines for neurological conditions, including multiple sclerosis, spinal muscular atrophy, neuromyelitis optica spectrum disorder, Alzheimer’s disease, Huntington’s disease, Parkinson’s disease and Duchenne muscular dystrophy. Roche Diagnostics has developed a broad range of approved and investigational tools, including digital and blood-based tests and cerebrospinal fluid (CSF) assays, aiming to more effectively detect, diagnose and monitor neurological conditions. Together with our partners, we are committed to pushing the boundaries of scientific understanding to solve some of the most difficult challenges in neurology today. About Roche Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions. Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them. Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law. References [1] Oh J, et al. Fenebrutinib Shows a Therapeutic Effect on MS Progressive Biology: Outcomes on Paramagnetic Rim Lesions and Slowly Expanding Lesions in the Phase III FENhance I/II and FENtrepid Trials in Relapsing and Primary Progressive Multiple Sclerosis (#O137). Presented at: MSToronto2026 10th Joint ACTRIMS-ECTRIMS Meeting; 23 October 2026; Toronto, Canada. [2] Cerqueira JJFCA, et al. No Evidence of Disease Activity With Fenebrutinib vs Teriflunomide in Relapsing Multiple Sclerosis: Results From the Phase III FENhance 1 and 2 Trials (#P1434). Presented at: MSToronto2026 10th Joint ACTRIMS-ECTRIMS Meeting; 22 October 2026; Toronto, Canada. [3] Sormani MP, et al. Efficacy of Fenebrutinib Versus Teriflunomide in Relapsing Multiple Sclerosis: Pooled Analysis Results From the FENhance 1 and 2 Studies (#O089). Presented at: MSToronto2026 10th Joint ACTRIMS-ECTRIMS Meeting; 21 October 2026; Toronto, Canada. [4] Marignier R, et al. Severity and Recovery of Relapses in Patients with Relapsing MOGAD Treated with Satralizumab: Results from the Phase 3 METEOROID Study (#O035). Presented at: MSToronto2026 10th Joint ACTRIMS-ECTRIMS Meeting; 22 October 2026; Toronto, Canada. [5] Deiva K, et al. OPERETTA 2: Continued Follow-Up of the Efficacy and Safety Profile of Ocrelizumab in Pediatric Relapsing-Remitting MS (#P1439). Presented at: MSToronto2026 10th Joint ACTRIMS-ECTRIMS Meeting; 22 October 2026; Toronto, Canada. [6] Bar-Or A, et al. Impact of Ocrelizumab vs Fingolimod on Immune Function in Pediatric Patients With MS in the OPERETTA 2 Study (#P1407). Presented at: MSToronto2026 10th Joint ACTRIMS-ECTRIMS Meeting; 22 October 2026; Toronto, Canada. [7] Banwell B, et al. Vaccination and Disease-Modifying Therapies: Impact of Ocrelizumab vs Fingolimod on Preexisting Vaccine Seropositivity and Vaccine-Preventable Infections in Pediatric Patients With MS in OPERETTA 2 (#P1415). Presented at: MSToronto2026 10th Joint ACTRIMS-ECTRIMS Meeting; 22 October 2026; Toronto, Canada. [8] Butzkueven H, et al. Ocrelizumab Maintains Clinical and Safety Outcomes in Older Patients (>55 Years) with Progressive Multiple Sclerosis: 2-Year Results from the CONSONANCE Study (#P1426). Presented at: MSToronto2026 10th Joint ACTRIMS-ECTRIMS Meeting; 22 October 2026; Toronto, Canada. [9] Marriott J, et al. Switching Patients with Multiple Sclerosis from Ofatumumab to Ocrelizumab: A Real-World Study of Canadian Healthcare Professionals (#EP2733). Presented at: MSToronto2026 10th Joint ACTRIMS-ECTRIMS Meeting; 21-23 October 2026; Toronto, Canada. [10] Ziemssen T, et al. Brain Volume Loss and T2 Lesion Activity in RRMS: Real-World Longitudinal Comparison of Ocrelizumab vs. Ofatumumab (#P0305). Presented at: MSToronto2026 10th Joint ACTRIMS-ECTRIMS Meeting; 21 October 2026; Toronto, Canada. [11] Levy M, et al. Safety and Efficacy of Satralizumab in Patients with Relapsing Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD): Results from the Phase 3 METEOROID Trial (PL5.006). Presented at: 78th Annual Meeting of the American Academy of Neurology (AAN) 2026; 21 April 2026; Chicago, IL, USA. Roche Global Media Relations Phone: +41 61 688 88 88 / e-mail: media.relations@roche.com Tristan Schmitz Phone: +41 79 529 70 35Lorena Corfas Phone: +41 79 568 24 95 Simon Goldsborough Phone: +44 797 32 72 915Karsten Kleine Phone: +41 79 461 86 83 Kirti Pandey Phone: +41 79 398 38 53Yvette Petillon Phone: +41 79 961 92 50 Irène Stephan Phone:  +41 79 377 83 75Albert Thottiyil Phone: +41 79 775 66 12 Roche Investor Relations Dr Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.comDr Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com Dr Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com  Investor Relations North America Loren Kalm Phone: +1 650 225 3217 e-mail: kalm.loren@gene.com  Attachment Media&Investor Release MSToronto2026 English ———————————————————————————————————————————————————————————— Lunit Highlights AI-Powered Pathology Insights Across Cancer Types at ESMO 2026 2026-10-21 · MarketersMEDIA · AI, SaaS, Healthcare, Biotech & pharma, Government & policy, Medical devices https://news.marketersmedia.com/lunit-highlights-ai-powered-pathology-insights-across-cancer-types-at-esmo-2026/89206863 Lunit (KRX: 328130), a leading provider of AI for cancer diagnostics and precision oncology, today announced that five studies involving its AI-powered pathology platform, Lunit SCOPE, will be presented at the European Society for Medical Oncology (ESMO) Congress 2026, taking place October 23–27 in Madrid, Spain. -- Five studies to be presented, with key research examining AI-based biomarker assessment and tumor micr ———————————————————————————————————————————————————————————— FIRST PATIENT SITE OPENS: Burjeel Cancer Institute at Burjeel Medical City Launches World’s First Clinical Site for BioSapien’s MediChip™ Chemotherapy Platform 2026-10-21 · MarketersMEDIA · SaaS, Healthcare, Biotech & pharma, Medical devices https://news.marketersmedia.com/first-patient-site-opens-burjeel-cancer-institute-at-burjeel-medical-city-launches-worlds-first-clinical-site-for-biosapiens-medichiptm-chemotherapy-platform/89206845 Burjeel Cancer Institute in Abu Dhabi has opened the world’s first clinical site for BioSapien’s MediChip, a biodegradable implant delivering chemotherapy directly to tumors. Its Phase I trial will evaluate safety in localized rectal cancer, exploring potential reductions in systemic exposure and treatment-related complications. -- Announced at Abu Dhabi Health Summit Burjeel Cancer Institute at Burjeel Medical City ———————————————————————————————————————————————————————————— Abbott's Cologuard Plus® receives CE Mark for colorectal cancer screening in Europe 2026-10-20 · Abbott · Medical devices https://abbott.mediaroom.com/2026-10-20-Abbotts-Cologuard-Plus-R-receives-CE-Mark-for-colorectal-cancer-screening-in-Europe Abbott's Cologuard Plus® receives CE Mark for colorectal cancer screening in Europe Cologuard Plus is a noninvasive, stool-based DNA screening test designed to detect both colorectal cancer and advanced precancerous lesions In the pivotal BLUE-C study, Cologuard Plus demonstrated 95% sensitivity for colorectal cancer at 94% specificity in the screened population CE Mark is an important regulatory milestone as Abbott ———————————————————————————————————————————————————————————— Roche to present pivotal data at ESMO 2026, showcasing advances across its lung and breast cancer late-stage portfolio 2026-10-19 · Roche · Healthcare, Automotive, Biotech & pharma, Medical devices https://www.roche.com/media/releases/med-cor-2026-10-19 Phase III Krascendo 1 results demonstrated divarasib’s superiority over current standard of care, first-generation KRAS G12C inhibitors in previously treated advanced G12C-mutated non-small cell lung cancer Patient-reported outcomes from phase III lidERA study showed improved efficacy of giredestrant over standard endocrine therapy is achieved without compromising tolerability and health-related quality of life in early-stage breast cancer Phase III results in Chinese patients with metastatic nasopharyngeal carcinoma demonstrate the potential of Tam-Peli, a next-generation B7-H3-targeted ADC, to deliver robust efficacy with a favourable safety profile in high-unmet-need solid tumours Basel, 19 October 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) will present new data, including two late-breaking abstracts, across lung, breast and other cancers at the 2026 European Society for Medical Oncology (ESMO) Annual Meeting, held from 23 to 27 October in Madrid. “Our presentations at ESMO 2026 highlight the depth and impact of Roche’s oncology pipeline, driven by emerging science capable of bringing new treatment benefits across diverse and high-unmet-need cancers,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “From establishing head-to-head superiority with divarasib in KRAS G12C-mutated lung cancer to advancing patient-centered oral SERD therapies like giredestrant and next-generation ADCs such as Tam-Peli, we are committed to delivering medicines that not only extend life, but also seek to improve treatment experience, tolerability and quality of life for people living with cancer. Divarasib demonstrated superior efficacy and best-in-class potential in KRAS G12C NSCLC Roche will share phase III Krascendo 1 results, which demonstrated divarasib’s best-in-class efficacy, advancing the standard of care in previously treated KRAS G12C-mutated lung cancer. Krascendo 1 is the only global head-to-head trial to evaluate a next-generation KRAS G12C inhibitor versus approved first-generation inhibitors.1 Results for this potential best-in-class, next-generation KRAS G12C-targeted therapy will be presented as a late-breaking abstract during a Presidential Symposium. Giredestrant data support its potential to become the new standard of care in early-stage and advanced breast cancer Roche will present new data highlighting the potential role of giredestrant, an investigational, oral, potent next-generation selective oestrogen receptor degrader (SERD) and full antagonist,2 in oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer, a subtype in which more than 90% of cases are diagnosed at an early-stage (I-III).3-6 Key presentations from early-stage to advanced disease include: Patient-reported outcomes from the phase III lidERA Breast Cancer trial suggesting that the improved efficacy of giredestrant compared to endocrine therapy is achieved without compromising tolerability or Health-Related Quality of Life. Exploratory biomarker findings from the evERA Breast Cancer trial of giredestrant in combination with everolimus in ER-positive, HER2-negative advanced breast cancer in the post-cyclin-dependent kinase 4/6 inhibitor setting. Updated interim results for giredestrant plus inavolisib from the MORPHEUS Breast Cancer trial evaluating giredestrant treatment combinations in ER-positive, HER2-negative locally advanced or metastatic breast cancer. Data demonstrate the potential of a next generation B7-H3 targeted antibody-drug conjugate (ADC) Tam-Peli (tambotatug pelitecan) New data will also be presented for Tam-Peli, an investigational next generation B7-H3-targeted ADC designed to deliver high-potency anti-tumour activity while limiting off-target toxicity.7 Tam-Peli is currently being investigated across multiple solid tumour indications: ESMO data include late-breaking interim phase III results in heavily pretreated recurrent/metastatic nasopharyngeal carcinoma, analyses of interstitial lung disease in patients with advanced solid tumours from phase I/II studies, and phase I efficacy and safety data for Tam-Peli in patients with locally advanced or metastatic NSCLC. These findings build on the TAISHAN-302 phase III data in second-line small cell lung cancer presented at the World Conference on Lung Cancer in September, where the study met all three specified endpoints of overall survival, progression free survival and objective response rate at its first interim analysis. Roche is developing and commercialising Tam-Peli outside mainland China, Hong Kong, and Macau, and plans to rapidly initiate global trials across multiple tumour types. Overview of key presentations featuring Roche medicines and molecules: Medicine or moleculeAbstract titleAbstract number/ presentation details Lung cancer DivarasibKrascendo 1: Efficacy and safety of divarasib (diva) vs sotorasib (soto) or adagrasib (ada) in previously treated locally advanced or metastatic KRAS G12C-mutated NSCLC.#LBA5 Proffered Paper Session Presidential Symposium II Sunday 25.10.2026 16:30 - 16:42 CET DivarasibKrascendo 3: A randomised, phase III trial in progress of divarasib vs immunotherapy or observation in patients with resected, stage II-IIIB, KRAS G12C+ non-small cell lung cancer. #2551 TiP Poster NSCLC, Early-Stage Monday 26.10.2026 12:00 – 12:45 CET Tam-PeliTambotatug pelitecan (YL201): Efficacy and safety in locally advanced/ metastatic NSCLC from a phase I study. #2577 Poster NSCLC, Locally Advanced Monday 26.10.2026 12:00 – 12:45 CET Non-specificImmunogenomic signature associated with ICI-related pneumonitis in non-small-cell lung cancer (NSCLC) patients.#4247 Rapid Oral Basic Science and Translational Research Sunday 25.10.2026 09:14 - 09:19 CET Breast cancer GiredestrantPatient (pt)-reported outcomes (PROs) from the phase III lidERA Breast Cancer (BC) trial of giredestrant (GIRE) in pts with oestrogen receptor-positive, HER2-negative early BC (ER+, HER2− eBC).  #538 Rapid Oral Breast Cancer, Early-Stage Friday 23.10.2026 16:20 – 16:25 CEST GiredestrantRetrospective exploratory biomarker (BM) analyses from evERA Breast Cancer (BC): A phase III trial of giredestrant (GIRE) + everolimus (E) in patients with oestrogen receptor-positive, HER2-negative advanced BC (ER+, HER2− aBC) in the post-CDK4/6 inhibitor (I) setting.#2 Rapid Oral Breast Cancer, Advanced Stage Saturday 24.10.2026 10:20 – 10:25 CEST GiredestrantUpdated interim analysis of giredestrant (GIRE) + inavolisib (INAVO) in MORPHEUS Breast Cancer (BC): A phase Ib/II study of GIRE treatment (tx) combinations in patients (pts) with oestrogen receptor-positive, HER2-negative locally advanced/metastatic BC (ER+, HER2− LA/mBC).#23 Poster Advanced Breast Cancer, Other Saturday 24.10.2026 12:00 – 12:45 CEST PertuzumabReal-world eligibility for DESTINY-Breast11 (DB-11) neoadjuvant escalation criteria and outcomes of DB-11-eligible vs DB-11-ineligible patients with HER2-positive early breast cancer (HER2+ eBC).#594 Poster Breast Cancer, Early-Stage Saturday 24.10.2026 12:00 – 12:45 CEST ZN-1041BREnnA: Phase II/III randomised study of ZN-A-1041 or tucatinib (TUC), in combination with trastuzumab + capecitabine (HX), in patients with HER2-positive locally advanced or metastatic breast cancer (HER2+LA/mBC) with or without central nervous system (CNS) metastases. #1796 TiP Poster HER2+ Breast Cancer Saturday 24.10.2026 12:00 – 12:45 CEST Solid tumours Tam-Peli Tambotatug pelitecan (YL201): Analyses of interstitial lung disease in patients with advanced solid tumours from phase I/II studies. #1057 Poster Developmental Therapeutics Friday 23.10.2026 15:15 – 16:00 CEST YL211 (cMET ADC)Phase I First-in-Human (FIH) Results of YL211, a c-Met targeting Antibody-Drug Conjugate (ADC), in patients (pts) with advanced solid tumors.#1017 Poster Developmental Therapeutics Friday 23.10.2026 15:15 – 16:00 CEST Tam-Peli Tam-Peli versus chemotherapy in heavily pretreated recurrent/metastatic nasopharyngeal carcinoma (R/M NPC): a multicenter, randomised, open-label, phase III study (TAISHAN-301).#LBA43 Proffered Paper Session Head and Neck Cancer Sunday 25.10.2026 08:40 - 08:50 CET Tecentriq (atezolizumab) + Avastin (bevacizumab)Outcomes by baseline tumor burden using 6-and-12 scores and the up-to-7 criteria in TALENTACE: phase III study of on-demand transarterial chemoembolization (TACE) combined with atezolizumab + bevacizumab (Atezo/Bev) or on demand TACE alone in patients  with systemically untreated, unresectable hepatocellular carcinoma (uHCC). #1700 ePoster Hepatocellular Carcinoma Tecentriq (atezolizumab)ATOMIC (A021502/AIO-KRK-0317): Presentation and outcomes in patients (pts) with stage III d-MMR early-onset colon cancer (EOCC) and average-onset colon cancer (AOCC).#858 Poster Colon Cancer Sunday 25.10.2026 12:00 - 12:45 CET Tecentriq (atezolizumab)Adjuvant atezolizumab in patients with MSI-high/MMR-deficient stage III colorectal cancer ineligible for oxaliplatin-based chemotherapy: the phase II ANTONIO-study (AIO-KRK-0220).#802 Poster Colon Cancer Sunday 25.10.2026 12:00 - 12:45 CET About Roche in Oncology For over 60 years, Roche has delivered transformative medicines and diagnostics, redefining the treatment of some of the most challenging cancers. Driven by a vision of a future where cancer can be cured, we focus our efforts on cancers with the highest societal impact and where we bring deep expertise, including breast, lung, and blood cancers, while pursuing breakthrough innovation in other areas of unmet need. Our pipeline features a diverse array of modalities, from small molecules and antibodies to next-generation ADCs and allogeneic CAR T-cell therapies. By advancing best-in-class precision medicine, pioneering novel combinations, and leveraging key technologies and partnerships, Roche tackles oncology's toughest challenges with the goal of delivering life-changing outcomes for people with cancer. About Roche Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions. Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them. Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law. References [1] Gadgeel S, et al. P3.12D.07 Divarasib Versus Adagrasib or Sotorasib in Pretreated KRAS G12C+ Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC). J of Thorac Oncol. 2024; 19 (10, Supplement): S349. [2] Martin M, et al. Giredestrant (GDC-9545) vs physician choice of endocrine monotherapy (PCET) in patients (pts) with ER+, HER2– locally advanced/metastatic breast cancer (LA/mBC): Primary analysis of the phase 2, randomised, open-label acelERA BC study. Presented at: ESMO Annual Meeting; 2022 September 9-13; Paris, France. Abstract #211MO. [3] F. Hoffmann‑La Roche Ltd. (2026) SEER Explorer All BCa by Stage. Data on file. [4] F. Hoffmann‑La Roche Ltd. (2026) Stage Distribution. Data on file. [5] F. Hoffmann‑La Roche Ltd. (2026) KREBS and TRM. Data on file. [6] F. Hoffmann‑La Roche Ltd. (2026). UK_CRUK_EDHub_IncidenceByStageRCRD_DataTable2026-01-08. Data on file. [7] Xu J, et al. Cancer Res. 2023;83:6304. Roche Global Media Relations Phone: +41 61 688 88 88 / e-mail: media.relations@roche.com Tristan Schmitz Phone: +41 79 529 70 35Lorena Corfas Phone: +41 79 568 24 95 Simon Goldsborough Phone: +44 797 32 72 915Karsten Kleine Phone: +41 79 461 86 83 Kirti Pandey Phone: +41 79 398 38 53Yvette Petillon Phone: +41 79 961 92 50 Irène Stephan Phone:  +41 79 377 83 75Albert Thottiyil Phone: +41 79 775 66 12 Roche Investor Relations Dr Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.comDr Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com Dr Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com  Investor Relations North America Loren Kalm Phone: +1 650 225 3217 e-mail: kalm.loren@gene.com   Attachment Media&Investor Release Roche ESMO 2026 English ———————————————————————————————————————————————————————————— FDA approves Roche’s Enspryng, a first-in-class IL-6R inhibitor, as the first and only at-home subcutaneous treatment option for thyroid eye disease (TED) 2026-10-16 · Roche · AI, Healthcare, Education, Food & drink, Biotech & pharma, Sustainability, Medical devices, Chemicals & materials https://www.roche.com/media/releases/med-cor-2026-10-16 FDA approval based on Phase III SatraGO-1 and -2 studies, with SatraGO-2 demonstrating a significant reduction in eye bulging (proptosis) and improvement in diplopia (double vision), with a favourable safety profile, regardless of TED activity or duration1,2   Enspryng (satralizumab) represents an important advance for people with TED, offering the first at-home SC treatment option every four weeks during maintenance phase, allowing for greater flexibility in how treatment is administered1 Enspryng is an anti-IL-6R mAb using novel recycling antibody technology designed to inhibit IL-6 signalling upstream of autoantibody-driven pathology2,3 TED is a rare autoimmune disease affecting approximately 155 out of every 100,000 people in the US that can lead to facial disfigurement and vision-threatening complications if left untreated3-7 Basel, 16 October 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved Enspryng® (satralizumab) for the treatment of adults with thyroid eye disease (TED), providing patients with the first and only at-home subcutaneous treatment option. Enspryng can be administered by a person living with TED or a caregiver following training from a healthcare provider.1 “Today’s FDA approval of Enspryng provides an important new option for people with thyroid eye disease, who have long faced limited treatment choices,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “As the first subcutaneous treatment for this condition, Enspryng offers a positive safety and efficacy profile and the potential for at-home administration.” "Treating thyroid eye disease requires balancing efficacy, safety, and the practical realities of long-term treatment,” said César A. Briceño, MD, Clinical Trial Investigator and Associate Professor of Ophthalmology at the Scheie Eye Institute, University of Pennsylvania. “As a clinical trial investigator, I have seen firsthand the potential of targeted therapies such as Enspryng. The availability of an effective subcutaneous treatment option could provide greater flexibility for both patients and physicians while reducing the logistical burden associated with infusion-based therapies. Enspryng has the potential to meaningfully expand our therapeutic options for patients with thyroid eye disease." The totality of data from the pivotal Phase III SatraGO programme (SatraGO-1 and SatraGO-2) provided clinically meaningful improvements in patients with TED.1,2 While SatraGO-1 did not meet its pre-specified primary efficacy endpoint at Week 24, SatraGO-2 achieved significant and clinically meaningful difference in proptosis response (52.9% in the Enspryng group compared to 23.4% in the placebo group) and in diplopia reduction (60.7% in the Enspryng group compared to 25.8% in the placebo group) in the active TED population.1,2 Consistent results were achieved in the overall population (including both active and chronic patients) in SatraGO-2.1,2 No new safety signals were identified in the SatraGO trials, with Enspryng’s safety profile consistent with its known profile in neuromyelitis optica spectrum disorder (NMOSD).1,2 Full results were shared at the American Society of Ophthalmic Plastic and Reconstructive Surgery (ASOPRS) Fall Scientific Symposium in October 2025.2 “Thyroid eye disease not only affects a person’s eyes through bulging and vision problems, but it also takes a profound emotional toll on confidence, identity, relationships and daily life,” said Christine Gustafson, Chief Executive Officer of the TED Community Organization. “Until now, our community has had very limited choices. The approval of Enspryng represents a critical turning point through a convenient, targeted option.” The approval in TED, following a priority review designation, marks the second indication for Enspryng, following an approval in neuromyelitis optica spectrum disorder (NMOSD) in 2020.1,8,9 This follows a recent acceptance by the FDA for priority review in myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD).10 Enspryng is also being studied in additional neurological autoimmune and inflammatory diseases that may benefit from inhibition of IL-6 mediated signalling. About SatraGO-1 and -2 SatraGO-1 (NCT05987423) and -2 (NCT06106828) are identically designed, Phase III, randomised, placebo-controlled, multicentre studies to determine the efficacy, durability and tolerability of Enspryng for the treatment of adults with active, moderate‑to‑severe TED and chronic TED. The studies enrolled a total of 258 patients from 19 countries. Participants were randomised 1:1 to receive Enspryng or placebo. The primary endpoints were the proportion of participants with active, moderate-to-severe TED who achieved an at least 2 mm reduction in proptosis in the study eye from baseline at week 24.2,3 About thyroid eye disease (TED) TED, also known as Graves’ ophthalmopathy, is a complex inflammatory autoimmune disease, affecting the area around the eyes and the eyes themselves, that can be sight-threatening, debilitating and disfiguring.4,5 The most common symptoms are redness, swelling of the eyes, eyelid retraction, appearance of a stare, bulging of one or both eyes (proptosis), double vision (diplopia) and pain.4,6 TED is a progressive rare disease that affects approximately 155 people out of every 100,000.3-5,7 It most commonly occurs in people with hyperthyroidism, approximately 50% of whom experience at least mild TED, but it can also affect people with hypothyroidism or normal thyroid function.4,11 Despite existing approved treatments for TED, a medical need remains for therapies that are effective, well-tolerated, and have a convenient route of administration.3 About Enspryng® (satralizumab) Enspryng, developed by Chugai, a member of the Roche Group, is a humanised monoclonal antibody that is designed to bind to both soluble and membrane-bound interleukin-6 receptors (IL-6R), thereby inhibiting IL-6 mediated signalling, a known key pathway involved in inflammation. Enspryng incorporates Chugai’s proprietary antibody recycling technology, which enables pH-dependent binding to IL-6R and repeated engagement of the target, extending antibody circulation and supporting sustained inhibition of IL-6 mediated signalling.1-3,12 Enspryng is the first and only IL-6R inhibitor treatment currently approved in approximately 90 countries for neuromyelitis optica spectrum disorder (NMOSD), including in the European Union and United States, with a well established safety profile in over 16,000 patients.1,13 Roche is committed to developing Enspryng in additional neurological autoimmune and inflammatory diseases that may benefit from inhibition of IL-6 mediated signalling, including autoimmune encephalitis (AIE) and myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). The FDA granted priority review of the Enspryng supplemental Biologics License Application (sBLA) for MOGAD in September 2026 with an approval decision expected in January 2027.10 Enspryng has orphan drug designation in the United States and European Union for NMOSD and MOGAD and in the United States for anti-NMDA receptor autoimmune encephalitis (anti-NMDAR AIE) and leucine-rich glioma-inactivated 1 autoimmune encephalitis (LGI1 AIE). About Roche in Ophthalmology At Roche, we are on a mission to save and restore eyesight. Over 330 million people around the world are blind, or living with vision loss, creating a profound personal and socioeconomic burden. With the broadest pipeline in Ophthalmology, we continue to invest at scale to redefine what is medically possible in eye care. Our comprehensive ophthalmology pipeline integrates diverse targets, advanced delivery systems, cell and gene therapies, and AI-augmented imaging capabilities, targeting multiple vision-threatening conditions, including retinal vascular and diabetic eye diseases, geographic atrophy, and autoimmune conditions, such as thyroid eye disease and uveitic macular edema. About Roche Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions. Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them. Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law. References [1] Enspryng (satralizumab) Prescribing Information. [2] Briceño C, et al. Primary Results of the Phase 3 SatraGO-1 and SatraGO-2 Trials: Efficacy and Safety of Satralizumab in Thyroid Eye Disease. Presented at the American Society of Ophthalmic Plastic and Reconstructive Surgery (ASOPRS) Fall Scientific Symposium, October 16–17, 2025. [3] Ezra D, Collins A, Haskova Z, et al. Targeting IL-6 Receptor Signaling with Satralizumab in Thyroid Eye Disease: Design of the Phase 3 SatraGO-1 and SatraGO-2 Trials. Ophthalmol Ther. 2025;14(12):3119-3132. doi:10.1007/s40123-025-01255-3 [4] McAlinden C. An overview of thyroid eye disease. Eye Vis (Lond). 2014;1:9. doi:10.1186/s40662-014-0009-8 [5] Bartalena L, Piantanida E, Gallo D, Lai A, Tanda ML. Epidemiology, Natural History, Risk Factors, and Prevention of Graves' Orbitopathy. Front Endocrinol (Lausanne). 2020;11:615993. doi:10.3389/fendo.2020.615993 [6] Thyroid eye disease. British Thyroid Foundation. Accessed October 12, 2026. https://www.btf-thyroid.org/thyroid-eye-disease-leaflet [7] Moledina M, Damato EM, Lee V. The changing landscape of thyroid eye disease: current clinical advances and future outlook. Eye (Lond). 2024;38(8):1425-1437. doi:10.1038/s41433-024-02967-9 [8] FDA grants Priority Review to Roche’s Enspryng, the first and only at-home subcutaneous treatment option for thyroid eye disease (TED). Accessed October 12, 2026. https://www.roche.com/media/releases/med-cor-2026-06-30 [9] FDA Approves Roche’s ENSPRYNG for Neuromyelitis Optica Spectrum Disorder (NMOSD). Accessed October 12, 2026. https://www.roche.com/media/releases/med-cor-2020-08-17 [10] U.S. FDA grants Priority Review for Roche’s Enspryng for MOGAD, an autoimmune disease with no approved treatments. Accessed October 12, 2026. https://www.roche.com/media/releases/med-cor-2026-09-10 [11] Bahn RS. Emerging pharmacotherapy for treatment of Graves' disease. Expert Rev Clin Pharmacol. 2012;5(6):605-607. doi:10.1586/ecp.12.54 [12] Heo YA. Satralizumab: First Approval. Drugs. 2020;80(14):1477-1482. doi:10.1007/s40265-020-01380-2 [13] Enspryng (satralizumab) Summary of Product Characteristics. Accessed October 12, 2026. https://www.ema.europa.eu/en/documents/product-information/enspryng-epar-product-information_en.pdf Roche Global Media Relations Phone: +41 61 688 88 88 / e-mail: media.relations@roche.com Tristan Schmitz Phone: +41 79 529 70 35Lorena Corfas Phone: +41 79 568 24 95 Simon Goldsborough Phone: +44 797 32 72 915Karsten Kleine Phone: +41 79 461 86 83 Kirti Pandey Phone: +41 79 398 38 53Yvette Petillon Phone: +41 79 961 92 50 Irène Stephan Phone:  +41 79 377 83 75Albert Thottiyil Phone: +41 79 775 66 12 Roche Investor Relations Dr Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.comDr Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com Dr Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com  Investor Relations North America Loren Kalm Phone: +1 650 225 3217 e-mail: kalm.loren@gene.com   Attachment Media & investor Release Enspryng TED FDA English ———————————————————————————————————————————————————————————— Stryker launches Sonopet® 3, delivering greater power and precision in ultrasonic tissue removal 2026-10-14 · Stryker · Finance, Healthcare, Medical devices https://www.prnewswire.com/news-releases/stryker-launches-sonopet-3-delivering-greater-power-and-precision-in-ultrasonic-tissue-removal-302907566.html Stryker (NYSE: SYK), a global leader in medical technologies, announced today that Sonopet 3, its latest ultrasonic bone and soft tissue removal... ———————————————————————————————————————————————————————————— Roche presents new Phase III one-year data for vamikibart in uveitic macular edema (UME), a serious cause of vision loss 2026-10-10 · Roche · AI, Healthcare, Food & drink, Biotech & pharma, Medical devices https://www.roche.com/media/releases/med-cor-2026-10-10 In the MEERKAT and SANDCAT studies, vamikibart demonstrated sustained improvements in vision and reductions in macular thickness in patients with UME at 52 weeks1,2 UME is the leading cause of moderate and severe vision loss in patients with uveitis, posing a significant risk of blindness if left untreated3,4 The FDA has accepted Roche's Biologics License Application (BLA), with an approval decision expected by July 2027 Basel, 10 October 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today new one-year data from the Phase III MEERKAT and SANDCAT studies evaluating investigational vamikibart compared with a sham procedure that mimics intravitreal (IVT) injections in adults with uveitic macular edema (UME). Across both studies, data continue to support the potential for rapid and sustained improvements in vision and reductions in macular thickness (swelling in the back of the eye due to retinal fluid) with vamikibart treatment. The data were presented at the American Academy of Ophthalmology 2026 Annual Meeting (AAO 2026) in New Orleans, LA.1 Additionally, the U.S. Food and Drug Administration (FDA) has accepted Roche’s Biologics License Application (BLA) for vamikibart for the treatment of UME. The filing acceptance is based on the results from the MEERKAT and SANDCAT studies. The FDA is expected to make a decision on approval by July 2027. If approved, vamikibart would be the first non-steroid targeted treatment for UME, with potential to establish a new standard of care. Regulatory submissions have also been filed and accepted in the European Union, China and Japan. “These one-year results strengthen vamikibart’s clinical profile, confirming that initial visual and anatomical improvements are maintained over 52 weeks,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “The acceptance of our application by the FDA and other regulatory bodies around the world brings us closer to offering a transformative, non-steroid therapy for people living with this sight-threatening condition.” “Currently, UME is commonly treated with off-label therapies or ocular steroids, the latter carrying significant long-term side effects like glaucoma and cataract formation,” said Nisha Acharya, M.D., M.S., Distinguished Professor of Ophthalmology at UCSF and Director of the Uveitis and Ocular Inflammatory Disease Service. “Vamikibart is the first non-steroid targeted therapy to demonstrate meaningful and sustained visual and anatomical improvements in people with UME, offering a potential new treatment option that directly targets the inflammation driving this sight-threatening condition.” The 16-week primary analysis results were presented at the AAO meeting in October 2025.2 In both MEERKAT and SANDCAT at 52 weeks, a numerically higher proportion of vamikibart-treated patients achieved vision gains compared to sham treatment on the primary endpoint. Key secondary endpoints showed this benefit was maintained, with sustained improvements in average change from baseline in best corrected visual acuity (BCVA) and average change from baseline in central subfield thickness (CST), a key measure of macular edema. Vamikibart demonstrated durable clinical benefit with a low treatment burden: approximately two-thirds of eligible patients required no retreatment after 16 weeks, while the majority of those who did required only one additional injection. Vamikibart was well tolerated, maintaining a favourable safety profile, with a low incidence of treatment-related ocular adverse events (AEs) and intraocular inflammation (IOI) events.1 UME is the leading cause of moderate-to-severe vision loss in individuals with uveitis, predominantly affecting working-age adults.3,4 Approximately 20% of UME patients progress to sustained blindness within three years of diagnosis.5 Standard-of-care treatments, primarily high-dose or local corticosteroids, carry substantial long-term risks, including secondary cataracts and elevated intraocular pressure leading to glaucoma.6-11 As a targeted anti-IL-6 monoclonal antibody, vamikibart is being developed to address these clinical unmet needs and deliver sustained visual preservation.1,12 About the MEERKAT and SANDCAT studies MEERKAT (NCT05642312) and SANDCAT (NCT05642325) are identical Phase III, global, parallel, multicentre, randomised, double-masked, sham comparator-controlled, 52-week trials of intravitreal (IVT) vamikibart in uveitic macular edema (UME). In both trials, patients were randomised and received treatment every four weeks with either 0.25 mg vamikibart, 1 mg vamikibart or sham IVT injection, for up to 16 weeks, followed by PRN treatment through week 52. The primary endpoint of both Phase III trials was the proportion of participants with a 15 letter or more improvement from baseline in best corrected visual acuity (BCVA) at week 16. Key secondary endpoints included the average change from baseline in BCVA and CST at week 16.  The safety of vamikibart was assessed through adverse events (AEs) such as treatment related ocular AEs, intraocular inflammation (IOI) and retinal occlusive vasculitis. The studies included participants with and without prior IVT treatment history and included patients with history of raised IOP and glaucoma.2,13,14 About uveitic macular edema (UME) UME is characterised by the buildup of fluid in the macula due to uveitis, an inflammatory eye condition.3 Although rare compared to other eye diseases, UME has a disproportionate impact on vision loss and blindness globally.3,15-20 It is the leading cause of moderate and severe vision loss in people with uveitis, and the most frequent sight threatening complication in uveitis.17-22 Uveitis accounts for 10% to 20% of blindness in the United States and Europe, and up to 25% of blindness in the developing world.23 UME has a significant negative impact on people's quality of life, including physical and mental health, social functioning, and visual function for day-to-day activities such as driving and reading.22,24,25 Steroids, the current standard of care for UME, are associated with significant serious side effects such as increased pressure in the eye, glaucoma and cataracts, and have recognised efficacy limitations.6-11 About vamikibart Vamikibart is an investigational monoclonal antibody that has been specifically engineered for IVT administration.1,2,12 It targets interleukin-6 (IL-6), a key cytokine in the inflammatory pathway in UME.1,2,12 In the Phase I DOVETAIL study, vamikibart provided rapid vision improvements and resolution of macular edema in people with UME.12 Vamikibart was also well tolerated, with no treatment-related serious adverse events reported.12 Based on the promising Phase I DOVETAIL data, Roche initiated the two identical Phase III vamikibart studies MEERKAT and SANDCAT.1,2,12 Vamikibart is being investigated in retinal diseases with recognised inflammatory pathways. Vamikibart has orphan drug designation in the United States and European Union. About Roche in Ophthalmology At Roche, we are on a mission to save and restore eyesight. Over 330 million people around the world are blind, or living with vision loss, creating a profound personal and socioeconomic burden. With the broadest pipeline in Ophthalmology, we continue to invest at scale to redefine what is medically possible in eye care. Our comprehensive ophthalmology pipeline integrates diverse targets, advanced delivery systems, cell and gene therapies, and AI-augmented imaging capabilities, targeting multiple vision-threatening conditions, including retinal vascular and diabetic eye diseases, geographic atrophy, and autoimmune conditions, such as thyroid eye disease and uveitic macular edema. About Roche Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions. Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them. Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law. References [1] Acharya N, et al. Vamikibart for Uveitic Macular Edema: Week 52 Efficacy and Safety Results From the Phase 3 MEERKAT and SANDCAT Trials. Presented at: the American Academy of Ophthalmology Annual Meeting (AAO 2026); 2026 October 10; New Orleans, Louisiana, United States. [2] Khurana RN, et al. Efficacy and Safety of Vamikibart in Patients With Uveitic Macular Edema: First Report of Phase 3 MEERKAT/SANDCAT Trials. Presented at: the American Academy of Ophthalmology Annual Meeting (AAO 2025); 2025 October 17; Orlando, Florida, United States. [3] Massa H, Pipis SY, Adewoyin T, Vergados A, Patra S, Panos GD. Macular edema associated with non-infectious uveitis: pathophysiology, etiology, prevalence, impact and management challenges. Clin Ophthalmol. 2019;13:1761-1777. doi:10.2147/OPTH.S180580 [4] Jones NP, Pradeep A, John B. Certification of vision impairment in patients with uveitis attending a specialist clinic. Ocul Immunol Inflamm. 2019;27(4):540-544. doi:10.1080/09273948.2018.1441874 [5] Do BK, et al. Visual Outcomes by Age and Sex in Uveitic Macular Edema: Real-World Retina Registry Analysis. Presented at: the 44th Annual Meeting of the American Society of Retinal Specialists; 2026 July 15–18; Montréal, Canada. [6] Rosenbaum JT, Bodaghi B, Couto C, et al. New observations and emerging ideas in diagnosis and management of non-infectious uveitis: A review. Semin Arthritis Rheum. 2019;49(3):438-445. doi:10.1016/j.semarthrit.2019.06.004 [7] Leandro L, Beare N, Bhan K, et al. Systemic corticosteroid use in UK Uveitis practice: results from the ocular inflammation steroid toxicity risk (OSTRICH) study. Eye. 2021;35(12):3342-3349. doi:10.1038/s41433-020-01336-6 [8] Nguyen QD, Hatef E, Kayen B, et al. A Cross-sectional Study of the Current Treatment Patterns in Noninfectious Uveitis among Specialists in the United States. Ophthalmology. 2011;118(1):184-190. doi:10.1016/j.ophtha.2010.03.029 [9] Fini ME, Schwartz SG, Gao X, et al. Steroid-induced ocular hypertension/glaucoma: Focus on pharmacogenomics and implications for precision medicine. Prog Retin Eye Res. 2017;56:58-83. doi:10.1016/j.preteyeres.2016.09.003 [10] Sen HN, Vitale S, Gangaputra SS, et al. Periocular Corticosteroid Injections in Uveitis: Effects and Complications. Ophthalmology. 2014;121(11):2275-2286. doi:10.1016/j.ophtha.2014.05.021 [11] Rice JB, White AG, Scarpati LM, Wan G, Nelson WW. Long-term Systemic Corticosteroid Exposure: A Systematic Literature Review. Clinical Therapeutics. 2017;39(11):2216-2229. doi:10.1016/j.clinthera.2017.09.011 [12] Sharma S, Lin P, Hu A, et al. Interleukin 6 Inhibition With Vamikibart for Uveitic Macular Edema: The Phase 1 DOVETAIL Nonrandomized Clinical Trial. JAMA Ophthalmol. 2026;144(5):442-451. doi:10.1001/jamaophthalmol.2026.0610 [13] Hoffmann-La Roche. A Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled Study to Investigate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Vamikibart Administered Intravitreally in Patients With Uveitic Macular Edema. clinicaltrials.gov; 2025. Accessed September 17, 2026. https://clinicaltrials.gov/study/NCT05642312 [14] Hoffmann-La Roche. A Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled Study to Investigate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Vamikibart Administered Intravitreally in Patients With Uveitic Macular Edema. clinicaltrials.gov; 2026. Accessed September 17, 2026. https://clinicaltrials.gov/study/NCT05642325 [15] Teper SJ. Update on the Management of Uveitic Macular Edema. J Clin Med. 2021;10(18):4133. doi:10.3390/jcm10184133 [16] Fardeau C, Champion E, Massamba N, LeHoang P. Uveitic macular edema. Eye. 2016;30(10):1277-1292. doi:10.1038/eye.2016.115 [17] Smith JR, Thorne JE, Flaxel CJ, et al. Treatment of Noninfectious Uveitic Macular Edema with Periocular and Intraocular Corticosteroid Therapies: A Report by the American Academy of Ophthalmology. Ophthalmology. 2024;131(9):1107-1120. doi:10.1016/j.ophtha.2024.02.019 [18] Sood G, Patel BC. Uveitic Macular Edema. In: StatPearls. StatPearls Publishing; 2023. Accessed September 17, 2026. http://www.ncbi.nlm.nih.gov/books/NBK562158/ [19] Tomkins-Netzer O, Lightman SL, Burke AE, et al. Seven-Year Outcomes of Uveitic Macular Edema: The Multicenter Uveitis Steroid Treatment Trial and Follow-up Study Results. Ophthalmology. 2021;128(5):719-728. doi:10.1016/j.ophtha.2020.08.035 [20] Matas J, Llorenç V, Fonollosa A, et al. Systemic Regulatory T Cells and IL-6 as Prognostic Factors for Anatomical Improvement of Uveitic Macular Edema. Front Immunol. 2020;11:579005. doi:10.3389/fimmu.2020.579005 [21] Tomkins-Netzer O, Talat L, Bar A, et al. Long-Term Clinical Outcome and Causes of Vision Loss in Patients with Uveitis. Ophthalmology. 2014;121(12):2387-2392. doi:10.1016/j.ophtha.2014.07.007 [22] Tallouzi MO, Moore DJ, Bucknall N, et al. Outcomes important to patients with non-infectious posterior segment-involving uveitis: a qualitative study. BMJ Open Ophth. 2020;5(1):e000481. doi:10.1136/bmjophth-2020-000481 [23] Cunningham ET, Zierhut M. Vision Loss in Uveitis. Ocular Immunology and Inflammation. 2021;29(6):1037-1039. doi:10.1080/09273948.2021.2017152 [24] Tomkins-Netzer O, Lightman S, Drye L, et al. Outcome of Treatment of Uveitic Macular Edema: The Multicenter Uveitis Steroid Treatment Trial 2-Year Results. Ophthalmology. 2015;122(11):2351-2359. doi:10.1016/j.ophtha.2015.07.036 [25] Frick KD, Drye LT, Kempen JH, et al. Associations among Visual Acuity and Vision- and Health-Related Quality of Life among Patients in the Multicenter Uveitis Steroid Treatment Trial. Invest Ophthalmol Vis Sci. 2012;53(3):1169. doi:10.1167/iovs.11-8259 Roche Global Media Relations Phone: +41 61 688 88 88 / e-mail: media.relations@roche.com Tristan Schmitz Phone: +41 79 529 70 35Lorena Corfas Phone: +41 79 568 24 95 Simon Goldsborough Phone: +44 797 32 72 915Karsten Kleine Phone: +41 79 461 86 83 Kirti Pandey Phone: +41 79 398 38 53Yvette Petillon Phone: +41 79 961 92 50 Irène Stephan Phone:  +41 79 377 83 75Albert Thottiyil Phone: +41 79 775 66 12 Roche Investor Relations Dr Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.comDr Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com Dr Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com  Investor Relations North America Loren Kalm Phone: +1 650 225 3217 e-mail: kalm.loren@gene.com   Attachment Media Investor Release Vamikibart in UME English ———————————————————————————————————————————————————————————— FDA approves Roche’s Tecentriq in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of a certain type of stage III colon cancer 2026-10-09 · Roche · Healthcare, Automotive, Food & drink, Biotech & pharma, Jobs & workplace, Internet & apps, Medical devices https://www.roche.com/media/releases/med-cor-2026-10-09 FDA approval is based on results from the landmark phase III ATOMIC study, published in The New England Journal of Medicine, which showed Tecentriq plus chemotherapy reduced the risk of disease recurrence or death by 50% compared to chemotherapy alone1 First approved adjuvant immunotherapy regimen for stage III dMMR colon cancer, positioning Tecentriq as a new post-surgery standard of care Nearly 25% of all colon cancers are diagnosed at stage III, and almost one in three patients with stage III colon cancer experience a recurrence within five years2,3 Approval marks the twelfth indication for Tecentriq in the US Basel, 9 October 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) and Tecentriq Hybreza® (atezolizumab and hyaluronidase-tqjs) in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of stage III deficient DNA mismatch repair (dMMR) colon cancer, a type of tumour characterised by high mutation rates. This approval marks the twelfth indication for Tecentriq in the US. “This approval provides a new adjuvant treatment option for people with stage III dMMR colon cancer who face a high risk of disease recurrence,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “Tecentriq combined with chemotherapy has the potential to become the new standard of care as the first approved immunotherapy-based regimen for this setting.” “Until now, the adjuvant standard of care for stage III colon cancer has not differed based on mismatch repair status,” said Frank A. Sinicrope, MD, Professor of Oncology at the Mayo Clinic and US Principal Investigator for the Alliance ATOMIC trial. “This milestone represents an important therapeutic advance that leverages immunotherapy to target the specific biology of dMMR stage III colon cancer after surgical resection. By reducing the risk of disease recurrence or death by 50%, atezolizumab plus chemotherapy is a practice-changing regimen that can improve clinical outcomes of this group of patients living with colon cancer, one of the most common cancers and a leading cause of cancer-related death.” The FDA approval is based on the landmark phase III ATOMIC study, recently published in The New England Journal of Medicine. ATOMIC demonstrated that adding Tecentriq to modified (m)FOLFOX6 chemotherapy reduced the risk of disease recurrence or death by 50%, compared to chemotherapy alone for people with stage III dMMR colon cancer, as determined by an immunohistochemistry test, such as the VENTANA® MMR RxDx Panel.1 The 36-month disease-free survival was 86% for Tecentriq combined with mFOLFOX6 compared with 76% in the mFOLFOX6 alone group. The safety profile was consistent with previous studies of Tecentriq and mFOLFOX6.1 Colon cancer remains one of the world's most common and deadliest tumours.4 Over one million people are diagnosed globally each year, and nearly 25% of all colon cancers are diagnosed at stage III.2-4 Despite surgery and chemotherapy, nearly 30% of stage III patients experience disease recurrence within five years.2,3 Approximately 15% of colon cancer patients present with dMMR or microsatellite instability-high (MSI-H) tumours, which indicate a higher mutation rate and thus have the potential to respond to immunotherapy.5 Roche is pursuing further regulatory filings for Tecentriq, including with the European Medicines Agency, to bring this immunotherapy-based adjuvant option to patients with dMMR colon cancer worldwide as soon as possible. About the ATOMIC study ATOMIC (A021502, NCT02912559) is a phase III, randomised, open-label, multicentre study investigating the addition of Tecentriq® (atezolizumab) to modified (m)FOLFOX6 chemotherapy (a combination of folinic acid, fluorouracil, and oxaliplatin) in patients with stage III colon cancer who have a deficiency in DNA mismatch repair (dMMR). The trial enrolled 712 patients. Participants were randomised 1:1 to receive either mFOLFOX6 plus Tecentriq for 12 cycles (six months) followed by Tecentriq monotherapy for 13 cycles (an additional six months), or mFOLFOX6 alone for 12 cycles. The primary endpoint is disease-free survival (DFS). The global study in the US was sponsored by the US National Cancer Institute (NCI), part of the National Institutes of Health, and led by the Alliance for Clinical Trials in Oncology (Alliance) with participation from other NCI-funded National Clinical Trials Network (NCTN) groups. Genentech, a member of the Roche Group, provided support for the study through a Cooperative Research and Development Agreement between NCI and Genentech. The trial was led globally by Frank A. Sinicrope, MD, Professor of Oncology at the Mayo Clinic and US Principal Investigator within the Alliance. German participation in this major international academic collaboration was enabled through close cooperation between the Alliance and the AIO-Studien-gGmbH, in partnership with the AIO (Arbeitsgemeinschaft Internistische Onkologie) of the German Cancer Society (Deutsche Krebsgesellschaft, DKG), under the national leadership of Prof. Dr. Anke Reinacher-Schick (Ruhr-Universität Bochum). AIO-affiliated study sites enrolled patients during the later recruitment phase, ensuring access for eligible patients in Germany. About Tecentriq® (atezolizumab) Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells. Tecentriq has been approved for some of the most aggressive and difficult-to-treat forms of cancer, and is the first PD-(L)1 cancer immunotherapy available in both subcutaneous and intravenous formulations. About Roche in oncology For over 60 years, Roche has delivered transformative medicines and diagnostics, redefining the treatment of some of the most challenging cancers. Driven by a vision of a future where cancer can be cured, we focus our efforts on cancers with the highest societal impact and where we bring deep expertise, including breast, lung, and blood cancers, while pursuing breakthrough innovation in other areas of unmet need. Our pipeline features a diverse array of modalities, from small molecules and antibodies to next-generation ADCs and allogeneic CAR T-cell therapies. By advancing best-in-class precision medicine, pioneering novel combinations, and leveraging key technologies and partnerships, Roche tackles oncology's toughest challenges with the goal of delivering life-changing outcomes for people with cancer. About Roche Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions. Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them. Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law. References [1] Sinicrope F, et al. Atezolizumab plus FOLFOX for Stage III Mismatch Repair–Deficient Colon Cancer. N Engl J Med. 2026;394:1155-1166. [2] Gonzalez B, et al. Analyzing recurrence in colorectal cancer: Is a five years follow-up enough? Annals of Oncology. 2024;35(1);11. [3] Nors J et al. Incidence of Recurrence and Time to Recurrence in Stage I to III Colorectal Cancer: A Nationwide Danish Cohort Study. JAMA Oncology. 2024;10(1):54–62. [4] World Health Organization. Cancer [Internet; cited 2026 October]. Available from: https://www.who.int/news-room/fact-sheets/detail/cancer. [5] Boland CR, et al. Microsatellite Instability in Colorectal Cancer. Gastroenterology. 2010;138:2073–2087. Roche Global Media Relations Phone: +41 61 688 88 88 / e-mail: media.relations@roche.com Tristan Schmitz Phone: +41 79 529 70 35Lorena Corfas Phone: +41 79 568 24 95 Simon Goldsborough Phone: +44 797 32 72 915Karsten Kleine Phone: +41 79 461 86 83 Kirti Pandey Phone: +41 79 398 38 53Yvette Petillon Phone: +41 79 961 92 50 Irène Stephan Phone:  +41 79 377 83 75Albert Thottiyil Phone: +41 79 775 66 12 Roche Investor Relations Dr Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.comDr Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com Dr Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com  Investor Relations North America Loren Kalm Phone: +1 650 225 3217 e-mail: kalm.loren@gene.com  Attachment Media&Investor Release FDA approval for Tecentriq Tecentriq Hybreza English ———————————————————————————————————————————————————————————— SAS named to 2026 Fast Company Next Big Things in Tech list 2026-10-06 · SAS · Healthcare, Logistics, Medical devices https://www.sas.com/en_us/news/press-releases/2026/october/sas-fast-company-next-big-things-in-tech.html?utm_medium=RSS&utm_source=press-release SAS is recognized by Fast Company for its digital twin technology used by Sterilcentral, Denmark’s largest medical sterilization provider, to optimize the cleaning, logistics planning and delivery of surgical instruments across hospitals. ———————————————————————————————————————————————————————————— Stryker Launches Mako 4 SmartRobotics™ in India, Advancing the Next Generation of Robotic-Assisted Joint Replacement 2026-10-05 · Stryker · Healthcare, Medical devices https://www.prnewswire.com/in/news-releases/stryker-launches-mako-4-smartrobotics-in-india-advancing-the-next-generation-of-robotic-assisted-joint-replacement-302894365.html Stryker, a global leader in medical technologies, announced the launch of Mako 4 SmartRobotics™ (Mako 4), the fourth generation of Mako, bringing its ... ———————————————————————————————————————————————————————————— Roche presents new data at EURETINA, highlighting Vabysmo’s real-world effectiveness and safety across major retinal conditions 2026-10-01 · Roche · AI, Healthcare, Education, Food & drink, Biotech & pharma, Government & policy, Internet & apps, Medical devices https://www.roche.com/media/releases/med-cor-2026-10-01b New real-world results for Vabysmo in nAMD, DME and RVO reinforce robust effectiveness and durability across previously untreated and treated eyes, with no new safety signals1-3 Advanced AI-enabled analysis of imaging confirms rapid and meaningful anatomical drying supporting Vabysmo as a standard-of-care therapy in routine clinical care4,5 With more than 5,000 patients enrolled, VOYAGER is the largest, prospective, non-interventional real-world dataset evaluating Vabysmo across diverse clinical practice settings worldwide1-3 Basel, 1 October 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today new data from the VOYAGER study evaluating the effectiveness, durability and safety of Vabysmo® (faricimab) in neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO).1-3 Across all study cohorts, results confirm the real-world effectiveness of Vabysmo in line with Phase III trial results, with vision gains and robust anatomical improvements in untreated eyes and stable or improved vision with improved anatomical outcomes in previously treated eyes.1-3 In the nAMD and DME cohorts of the study, vision and central subfield thickness (CST) improved in previously untreated eyes, while vision remained stable and CST improved in previously treated eyes, after 12 months of Vabysmo treatment.1,2 In RVO, both subtypes of the disease showed improvements in efficacy in people treated with Vabysmo.3 In the central/hemi-RVO cohort, vision and CST improved in both previously untreated and treated eyes after six months of Vabysmo therapy.3 In the branch RVO cohort, vision and CST improved in previously untreated eyes, while vision remained stable and CST improved in previously treated eyes, after six months of Vabysmo treatment.3 The data are being presented at the EURETINA 2026 Annual Meeting in Vienna, Austria. “These real-world results underscore how the efficacy and safety observed in our pivotal Vabysmo studies translate directly into routine clinical practice globally,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “The sustained visual improvements and meaningful anatomical drying seen in the VOYAGER study reinforce the role of Vabysmo in helping to address important unmet needs for patients with retinal conditions.” “In daily clinical practice, we manage diverse patient populations with complex treatment histories who don’t always mirror the strict entry criteria of controlled Phase III trials.” said Professor Robyn Guymer, Chair of the VOYAGER Steering Committee and Deputy Director of the Centre for Eye Research Australia. “The latest VOYAGER data give physicians from across the world the confidence that Vabysmo delivers sustained visual gains, meaningful anatomical drying, and an established safety profile in everyday practice – whether a patient is starting treatment for the first time or transitioning from another therapy.” The new VOYAGER real-world data in nAMD, DME and RVO are consistent with previous Phase III study results and demonstrate the effectiveness, durability and safety of Vabysmo across diverse global practices.1-3 Across all cohorts of the study, the presence of subretinal fluid (SRF) or intraretinal fluid (IRF) was consistently reduced in previously untreated and treated eyes.1-3 In the nAMD and DME groups, fewer Vabysmo injections were received during months 7-12 compared with months 1-6, suggesting extension of treatment intervals.1,2  Mean change in visual acuity (VA) Early Treatment Diabetic Retinopathy Study (ETDRS) lettersMean change in central subfield thickness (CST) µmPresence of subretinal fluid (SRF) % of eyesPresence of intraretinal fluid (IRF) % of eyes nAMD (after 12 months of Vabysmo treatment)1 No prior treatment+4.6–110.572.1→25.348.5→20.6 Previously treated-0.1-26.161.6→37.935.4→25.0 DME (after 12 months of Vabysmo treatment)2 No prior treatment+8.2-127.826.5→6.887.3→58.1 Previously treated+2.7-71.322.1→9.380.5→68.1 Branch RVO (after 6 months of Vabysmo treatment)3 No prior treatment+10.0-171.336.3→11.883.8→50.0 Previously treated+2.0-59.015.9→6.682.6→80.3 Central/hemi-RVO (after 6 months of Vabysmo treatment)3 No prior treatment+16.6-287.450.7→9.885.7→29.4 Previously treated+3.9-63.414.9→10.389.4→74.4 In VOYAGER, the Vabysmo safety profile was generally consistent with that established in the Phase III studies in nAMD, DME and RVO.1-3 About VOYAGER VOYAGER is the largest global, prospective, non-interventional real-world study of Vabysmo (faricimab).1-3 It captures real-world data from 28 countries/regions across six continents representing more than 5,000 patients treated for neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME) or retinal vein occlusion (RVO).1-3 The study leverages state-of-the-art AI and deep learning algorithms to evaluate SD-OCT images captured during routine clinical practice.4-6 About Vabysmo® (faricimab) Vabysmo is the first bispecific antibody approved for the eye.7-9 It targets and inhibits two signalling pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). Ang-2 and VEGF-A contribute to vision loss by destabilising blood vessels, causing new leaky blood vessels to form and increasing inflammation. By blocking pathways involving Ang-2 and VEGF-A, Vabysmo is designed to stabilise blood vessels.9,10 Vabysmo is approved in more than 100 countries around the world, including the United States (US), Japan, the United Kingdom and the European Union (EU) for people with neovascular or ‘wet’ age-related macular degeneration and diabetic macular edema, and in more than 60 countries, including the US, EU and Japan, for people with macular edema following retinal vein occlusion (RVO).7,8,11-14 Review by other health authorities is ongoing. About Roche in Ophthalmology At Roche, we are on a mission to save and restore eyesight. Over 330 million people around the world are blind, or living with vision loss, creating a profound personal and socioeconomic burden. With the broadest pipeline in Ophthalmology, we continue to invest at scale to redefine what is medically possible in eye care. Our comprehensive ophthalmology pipeline integrates diverse targets, advanced delivery systems, cell and gene therapies, and AI-augmented imaging capabilities, targeting multiple vision-threatening conditions, including retinal vascular and diabetic eye diseases, geographic atrophy, and autoimmune conditions, such as thyroid eye disease and uveitic macular edema. About Roche Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions. Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them. Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law. References [1] Guymer R, et al. One-year Clinical and Anatomical Outcomes of Faricimab Treatment in Eyes With nAMD From the Global, Prospective Observational VOYAGER Study. Presented at: 26th EURETINA Congress; 1–4 October 2026; Vienna, Austria. [2] Sheth V, et al. One–Year Clinical and Anatomical Outcomes of Faricimab Treatment in Eyes With DME From the Global, Prospective Observational VOYAGER Study. Presented at: 26th EURETINA Congress; 1–4 October 2026; Vienna, Austria. [3] Hattenbach L-O, et al. Real-World Clinical and Anatomical Outcomes With Faricimab in Patients With Retinal Vein Occlusion From a Global, Prospective Observational Study: The VOYAGER Study. Presented at: 26th EURETINA Congress; 1–4 October 2026; Vienna, Austria. [4] Bailey C, et al. Anatomical Outcomes of Faricimab in Patients with Neovascular Age-Related Macular Degeneration: 12-Month Real-World Imaging from the VOYAGER Study. Presented at:26th EURETINA Congress; 1–4 October 2026; Vienna, Austria. [5] Koh A, et al. Anatomical Outcomes of Faricimab in Patients with Diabetic Macular Edema: 12-Month Real-World Imaging from the VOYAGER Study. Presented at: 26th EURETINA Congress; 1–4 October 2026; Vienna, Austria. [6] Guymer R, Bailey C, Chaikitmongkol V, et al. Rationale and Design of VOYAGER: Long-term Outcomes of Faricimab and Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema in Clinical Practice. Ophthalmol Sci. 2024;4(3):100442. doi:10.1016/j.xops.2023.100442. [7] United States (US) Food and Drug Administration (FDA). Highlights of Prescribing Information, Vabysmo. April 2026. [Internet; cited September 2026]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761235s008lbl.pdf [8] Medicines and Healthcare products Regulatory Agency approves faricimab through international work-sharing initiative. May 17, 2022. [Internet; cited September 2026]. Available from: https://www.gov.uk/government/news/mhra-approves-faricimab-through-international-work-sharing-initiative [9] Heier JS, Khanani AM, Quezada Ruiz C, et al. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials. Lancet. 2022;399(10326):729-740. doi:10.1016/S0140-6736(22)00010-1. [10] Wykoff CC, Abreu F, Adamis AP, et al. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with diabetic macular oedema (YOSEMITE and RHINE): two randomised, double-masked, phase 3 trials. Lancet. 2022;399(10326):741-755. doi:10.1016/S0140-6736(22)00018-6. [11] European Medicines Agency. Summary of Product Characteristics, Vabysmo. August 2026. [Internet; cited September 2026]. Available from: https://www.ema.europa.eu/en/documents/product-information/vabysmo-epar-product-information_en.pdf. [12] Chugai obtains regulatory approval for Vabysmo, the only bispecific antibody in the ophthalmology field, for additional indication of macular edema associated with RVO. [Internet; cited September 2026]. Available from: https://www.chugai-pharm.co.jp/english/news/detail/20240326160000_1054.html. [13] Chugai obtains regulatory approval for Vabysmo, the first bispecific antibody in ophthalmology, for nAMD and DME. [Internet; cited September 2026]. Available from: https://www.chugai-pharm.co.jp/english/news/detail/20220328160002_909.html. [14] Roche data on file. Roche Global Media Relations Phone: +41 61 688 88 88 / e-mail: media.relations@roche.com Tristan Schmitz Phone: +41 79 529 70 35Lorena Corfas Phone: +41 79 568 24 95 Simon Goldsborough Phone: +44 797 32 72 915Karsten Kleine Phone: +41 79 461 86 83 Kirti Pandey Phone: +41 79 398 38 53Yvette Petillon Phone: +41 79 961 92 50 Irène Stephan Phone:  +41 79 377 83 75Albert Thottiyil Phone: +41 79 775 66 12 Attachment Media Release Vabysmo EURETINA 2026 English ———————————————————————————————————————————————————————————— Roche’s giredestrant combination significantly improved progression-free survival in ER-positive advanced breast cancer in phase III evERA data published in The New England Journal of Medicine 2026-10-01 · Roche · Healthcare, Food & drink, Biotech & pharma, Internet & apps, Medical devices https://www.roche.com/media/releases/med-cor-2026-10-01 Giredestrant plus everolimus reduced the risk of disease progression or death by 44% and 62% in ITT and ESR1-mutated populations, respectively, versus standard endocrine therapy plus everolimus1 By targeting resistance to endocrine treatments, the giredestrant combination seeks to delay disease progression and improve overall patient outcomes1 The FDA has set a PDUFA goal date for giredestrant in early-stage breast cancer of 30 November 2026 and in advanced disease of 18 December 2026 Basel, 1 October 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that detailed results from the evERA Breast Cancer study, showing investigational giredestrant in combination with everolimus significantly improved progression-free survival (PFS) versus standard endocrine therapy plus everolimus, were published in The New England Journal of Medicine (NEJM). The evERA trial is evaluating giredestrant, an investigational oral selective oestrogen receptor degrader (SERD), in combination with everolimus in people with oestrogen receptor (ER)-positive locally advanced or metastatic breast cancer who had disease progression or recurrence following treatment with a cyclin-dependent kinase (CDK)4/6 inhibitor and endocrine therapy.1 “Despite advancements with CDK4/6 inhibitor treatment in the first-line setting, many people with advanced breast cancer will eventually experience disease progression as their tumours become resistant to endocrine therapy,” said Dr Erica L. Mayer, Medical Oncologist at Dana-Farber Cancer Institute. “The evERA trial demonstrated that the giredestrant combination significantly delayed disease progression, potentially offering a promising all-oral treatment option in a setting where there remains a need for additional treatments to improve patient outcomes.” In the ESR1-mutated population, the median PFS was 10.0 months with giredestrant plus everolimus compared with 5.5 months in the comparator arm (stratified hazard ratio [HR]=0.38, 95% CI: 0.27-0.54, p<0.001).1 In the intent-to-treat (ITT) population, the median PFS was 8.8 months compared with 5.5 months in the giredestrant and comparator arms, respectively (HR=0.56, 95% CI: 0.44-0.71, p<0.001).1 Overall survival (OS) data were immature at the time of analysis, but a clear positive trend has been observed in the ITT (HR=0.69, 95% CI: 0.47-1.00) and ESR1-mutated populations (HR=0.62, 95% CI: 0.38-1.02).1 Follow-up for OS will continue to the next analysis. Adverse events for the giredestrant combination were manageable and consistent with the known safety profiles of the individual medicines.1 No unexpected safety findings were observed, including no photopsia and low rates of bradycardia.1 “The evERA results represent an important step forward for people with ER-positive advanced breast cancer and underscore the potential for giredestrant to help address the challenge of disease progression in this setting,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “Together with the positive phase III lidERA results in early breast cancer, these findings reinforce the potential of giredestrant to redefine care in both metastatic and early disease settings.” Additional evERA analyses were presented at the 2026 American Society of Clinical Oncology Annual Meeting, showing that giredestrant plus everolimus prolongs PFS2 (time from randomisation to disease progression following second-line therapy) and chemotherapy-free survival compared with standard endocrine therapy, suggesting that the clinical benefit may be sustained beyond initial progression.2 Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer accounts for approximately 70% of breast cancer cases.3 Resistance to endocrine therapies, particularly in the post-CDK inhibitor setting, increases the risk of disease progression and is associated with poor outcomes.3,4 evERA was the first positive phase III readout for giredestrant, followed by the lidERA Breast Cancer study in the early-stage setting.1,5 Based on these evERA data, the US Food and Drug Administration (FDA) accepted Roche’s New Drug Application (NDA) for giredestrant in combination with everolimus for the treatment of people with ER-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer whose disease has recurred during or after completing endocrine-based adjuvant therapy, or who have progressed on at least one endocrine-based regimen in the metastatic setting. The FDA is expected to decide on the application by 18 December 2026. The FDA also accepted an NDA under Priority Review for giredestrant as an adjuvant treatment for adults with ER-positive, HER2-negative, stage I, II, and III breast cancer based on the lidERA results. The FDA has set a Prescription Drug User Fee Act goal date of 30 November 2026. Roche’s expanding giredestrant clinical development programme spans distinct treatment settings and lines of therapy, reflecting our commitment to deliver innovative medicines to as many people with HR-positive breast cancer as possible. About the evERA Breast Cancer study evERA Breast Cancer [NCT05306340] is a phase III, randomised, open-label, multicentre study evaluating the efficacy and safety of giredestrant in combination with everolimus versus standard endocrine therapy in combination with everolimus in people with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer who have had previous treatment with cyclin-dependent kinase (CDK)4/6 inhibitor and endocrine therapy, either in the adjuvant or locally advanced/metastatic setting.6 The co-primary endpoints are investigator-assessed progression-free survival in the intention-to-treat and ESR1-mutated populations, defined as the time from randomisation to the time when the disease progresses or a patient dies from any cause.6 In the post-CDK inhibitor setting, up to 40% of people with ER-positive disease have ESR1 mutations.7,8 Key secondary endpoints include overall survival, objective response rate, duration of response, clinical benefit rate and safety.6 About giredestrant Giredestrant is an investigational, oral, potent next-generation selective oestrogen receptor degrader and full antagonist.9 Giredestrant is designed to block oestrogen from binding to the oestrogen receptor (ER), triggering its breakdown (known as degradation) and stopping or slowing down the growth of cancer cells.10 Giredestrant has an extensive clinical development programme including five company-sponsored phase III clinical trials to address the needs of patients acrossmultiple treatment settings and lines of therapy: Giredestrant versus standard endocrine therapy as adjuvant treatment in ER-positive, human epidermal growth factor receptor 2 (HER2)-negative early-stage breast cancer (lidERA Breast Cancer; NCT04961996)11 Giredestrant plus everolimus versus standard endocrine therapy plus everolimus in ER-positive, HER2-negative, locally advanced or metastatic breast cancer (evERA Breast Cancer; NCT05306340)6 Giredestrant plus palbociclib versus letrozole plus palbociclib in ER-positive, HER2-negative, endocrine-sensitive, recurrent locally advanced or metastatic breast cancer (persevERA Breast Cancer; NCT04546009)12 Giredestrant plus investigator’s choice of a cyclin-dependent kinase (CDK)4/6 inhibitor versus fulvestrant plus a CDK4/6 inhibitor in ER-positive, HER2-negative advanced breast cancer resistant to adjuvant endocrine therapy (pionERA Breast Cancer; NCT06065748)13 Giredestrant plus Phesgo® (pertuzumab, trastuzumab, and hyaluronidase subcutaneous) versus Phesgo in ER-positive, HER2-positive locally advanced or metastatic breast cancer (heredERA Breast Cancer; NCT05296798)14 About hormone receptor (HR)-positive breast cancer Globally, the burden of breast cancer continues to grow, with 2.3 million women diagnosed and 670,000 dying from the disease every year.15 Breast cancer remains the number one cause of cancer-related deaths amongst women, and the second most common cancer type.16 HR-positive, human epidermal growth factor receptor 2-negative breast cancer accounts for approximately 70% of breast cancer cases and the majority are diagnosed in the early-stage.3 A defining feature of HR-positive breast cancer is that its tumour cells have receptors that attach to hormones like oestrogen, which can contribute to tumour growth.17 Despite treatment advances, HR-positive breast cancer remains particularly challenging to treat due to its biological complexity.18 Patients often face the risk of disease progression, treatment side effects and resistance to endocrine therapy.18,19 There is an urgent need for more effective treatments that can delay clinical progression and reduce the burden of treatment on people’s lives.18,19 About Roche in breast cancer Roche has been advancing breast cancer research for more than 30 years, and it continues to be a major focus of research and development. Our legacy began with the development of the first targeted therapy for human epidermal growth factor receptor 2-positive breast cancer, and we continue to push the boundaries of science to address the complexities of all breast cancer subtypes. By leveraging our dual expertise in pharmaceuticals and diagnostics, we are dedicated to providing tailored treatment approaches and improving outcomes for every patient, from early to advanced stages of the disease. Together with our partners, we are relentlessly pursuing a cure, as we strive for a future where no one dies from breast cancer. About Roche Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions. Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical Divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them. Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law. References [1] Mayer E, et al. Giredestrant plus Everolimus in Advanced Breast Cancer. NEJM; 2026 October. DOI:10.1056/NEJMoa2602457. [2] Jhaveri K, et al. Post-progression treatment (tx) analyses of evERA Breast Cancer (BC): A phase III trial of giredestrant (GIRE) + everolimus (E) in patients (pts) with estrogen receptor–positive, HER2-negative advanced BC (ER+, HER2– aBC) previously treated with a CDK4/6 inhibitor (i). Presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; 2026 May 29 – June 02; Chicago, Illinois, US. #1016. [3] Lim E, et al. The natural history of hormone receptor-positive breast cancer. Oncology (Williston Park). 2012;26(8):688-94,696. [4] Sahin T, et al. Post-progression treatment options after CDK4/6 inhibitors in hormone receptor-positive, HER2-negative metastatic breast cancer. Cancer Treatment Reviews. 2025 April;135:102924. [5] Bardia A, et al. Giredestrant vs standard-of-care endocrine therapy as adjuvant treatment for patients with estrogen receptor-positive, HER2-negative early breast cancer: Results from the global Phase III lidERA Breast Cancer trial. Presented at: San Antonio Breast Cancer Symposium (SABCS); 2025 December 9-12; San Antonio, Texas, United States. #GS1-10. [6] ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With the Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (evERA Breast Cancer) [Internet; cited 2026 September]. Available from: https://clinicaltrials.gov/study/NCT05306340. [7] Meisel J L, et al. Real-world estrogen receptor 1 (ESR1) testing patterns and results in U.S. patients with metastatic breast cancer, 2018-2024. JCO Oncol Pract. 2025;21:579. [8] Chaudhary N, et al. CDK4/6i-treated HR+/HER2- breast cancer tumors show higher ESR1 mutation prevalence and more altered genomic landscape. npj Breast Cancer. 2024;10,15. [9] Martin M, et al. Giredestrant (GDC-9545) vs physician choice of endocrine monotherapy (PCET) in patients (pts) with ER+, HER2– locally advanced/metastatic breast cancer (LA/mBC): Primary analysis of the phase 2, randomised, open-label acelERA BC study. Presented at: The ESMO Annual Meeting; 2022 September 9-13; Paris, France. Abstract #211MO. [10] Metcalfe C, et al. GDC-9545: A novel ER antagonist and clinical candidate that combines desirable mechanistic and pre-clinical DMPK attributes. Presented at: SABCS; 2018 December 4-8; San Antonio, Texas, USA. Abstract #P5-04-07. [11] ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer) [Internet; cited 2026 September]. Available from: https://clinicaltrials.gov/study/NCT04961996. [12] ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer) [Internet; cited 2026 September]. Available from: https://clinicaltrials.gov/study/NCT04546009. [13] ClinicalTrials.gov. A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer) [Internet; cited 2026 September]. Available from: https://clinicaltrials.gov/study/NCT06065748. [14] ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Giredestrant in Combination With Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) Versus Phesgo in Participants With Locally Advanced or Metastatic Breast Cancer (heredERA Breast Cancer) [Internet; cited 2026 September]. Available from: https://clinicaltrials.gov/study/NCT05296798. [15] World Health Organization. Breast Cancer [Internet; cited 2026 September]. Available from: https://www.who.int/news-room/fact-sheets/detail/breast-cancer. [16] World Health Organization. Cancer Today [Internet; cited 2026 September]. Available from: https://gco.iarc.fr/today/en/dataviz/bars?mode=cancer&types=1&group_populations=1&sexes=2&key=asr&age_end=14. [17] National Cancer Institute. Hormone Therapy for Breast Cancer [Internet; cited 2026 September]. Available from: https://www.cancer.gov/types/breast/breast-hormone-therapy-fact-sheet. [18] Hanker A, et al. Overcoming Endocrine Resistance in Breast Cancer. Canc Cell. 2020 Apr 13;37(4):496–513. [19] Başaran G, et al. Ongoing unmet needs in treating estrogen receptor-positive/HER2-negative metastatic breast cancer. Cancer Treat Rev. 2018 Feb;63:144-55. Roche Global Media Relations Phone: +41 61 688 8888 / e-mail: media.relations@roche.com Tristan Schmitz Phone: +41 79 529 70 35Lorena Corfas Phone: +41 79 568 24 95 Simon Goldsborough Phone: +44 797 32 72 915Karsten Kleine Phone: +41 79 461 86 83 Kirti Pandey Phone: +41 79 398 38 53Yvette Petillon Phone: +41 79 961 92 50 Irène Stephan  Phone: +41 79 377 83 75 Albert Thottiyil  Phone: +41 79 775 66 12 Attachment 20261001 evERA phase III NEJM ———————————————————————————————————————————————————————————— Roche’s fenebrutinib is the first BTK inhibitor to receive U.S. FDA filing acceptance in both relapsing and primary progressive multiple sclerosis 2026-09-30 · Roche · Healthcare, Food & drink, Biotech & pharma, Internet & apps, Medical devices, Chemicals & materials https://www.roche.com/media/releases/med-cor-2026-09-30 Fenebrutinib cut relapses by 51% and 58% vs teriflunomide in Phase III RMS trials (FENhance 1 & 2) while showing a consistent, positive trend in delaying disability1 Fenebrutinib became the first investigational medicine in more than a decade to slow disability progression in a Phase III PPMS trial (FENtrepid), with numerical benefit vs Ocrevus2 Fenebrutinib is designed to address two drivers of MS – acute inflammation causing relapses and chronic brain inflammation driving disability progression1,2 If approved, fenebrutinib would become the first BTK inhibitor and first high-efficacy oral treatment for both RMS and PPMS, offering a new option for the nearly 1 million Americans living with MS3 Basel, 30 September 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that the United States Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) under priority review for fenebrutinib, an investigational non-covalent Bruton’s tyrosine kinase (BTK) inhibitor for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). The filing acceptance is based on data from the comprehensive clinical programme, including the Phase III FENhance 1 and 2 RMS studies and the Phase III FENtrepid PPMS study.1,2 "People living with multiple sclerosis need treatments that go beyond controlling relapses to help preserve function and independence as the disease progresses," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "Three Phase III studies have demonstrated the potential for fenebrutinib to address both relapsing and progressive disease, thereby bringing us closer to an oral treatment that could make a meaningful difference across the MS spectrum." “Ocrevus transformed how we treat MS, helping more than 525,000 people live a life less defined by their disease. Yet, over a third of all people with MS still receive lower-efficacy treatment,” said Teresa Graham, Roche’s Chief Executive Officer, Pharma. “If approved, fenebrutinib could open a new chapter as the first high-efficacy oral therapy for both relapsing and primary progressive MS, helping to control disease activity while giving people more flexibility and choice.” Concurrently addressing the life-disrupting relapses and long-term disease progression – the slow, steady loss of physical and mental abilities over time – remains one of the greatest challenges in MS.4 Fenebrutinib is designed to act throughout the body and to cross the blood-brain barrier into the central nervous system to target both the acute inflammation that causes relapses and the chronic inflammation that is thought to drive disability progression.1,2 The NDA for fenebrutinib is supported by three positive Phase III studies: The FENhance 1 and 2 RMS studies showed that fenebrutinib significantly reduced relapses and both active and chronic brain lesions compared with standard of care, teriflunomide. Fenebrutinib reduced the annualised relapse rate (ARR) by 51.1% (p<0.001) in FENhance 1 and 58.5% (p<0.00001) in FENhance 2 compared with teriflunomide over 96 weeks. This equates to patients having approximately one relapse every 17 years, which is the lowest relapse rate seen in Phase III MS studies. In addition, measures of disability progression, including 12-week composite confirmed disability progression (cCDP12), showed consistent positive trends favouring fenebrutinib over teriflunomide.1 The FENtrepid PPMS study showed fenebrutinib met its primary endpoint of non-inferiority compared with Ocrevus® (ocrelizumab), the current standard of care and only approved medicine for PPMS, in reducing disability progression. Fenebrutinib numerically reduced the risk of progression by 12% compared to Ocrevus, as measured by the time to onset of cCDP12 (hazard ratio [HR] 0.88; 95% confidence interval [CI]: 0.75, 1.03), with curves separating as early as 24 weeks. A consistent treatment effect on disability progression was observed across patient subgroups, including those without active inflammation, and for the entire treatment duration after 24 weeks.2 The overall rate of serious adverse events for fenebrutinib and teriflunomide, respectively, was 9% and 9% in FENhance 1 and 11% and 6% in FENhance 2. The overall rate of serious adverse events in FENtrepid was 19% for fenebrutinib and 19% for Ocrevus. Liver enzyme elevations were comparable between the fenebrutinib and teriflunomide arms in the RMS studies and observed more often with fenebrutinib compared to Ocrevus in the PPMS study. While an imbalance in reported fatalities was observed across the three pivotal studies, the deaths occurred at different timepoints and had various causes.1,2 Overall, fenebrutinib has shown a manageable safety profile across the three Phase III trials and earlier studies, with a large safety database including more than 2,700 study participants.1,2,5 About fenebrutinib Fenebrutinib is an investigational oral, central nervous system (CNS)-penetrant, reversible and non-covalent Bruton’s tyrosine kinase (BTK) inhibitor with an optimised pharmacokinetics (PK) profile. Fenebrutinib can act throughout the body and also cross the blood-brain barrier into the CNS to target chronic inflammation. It is uniquely designed to target relapsing and progressive biology by inhibiting cells in the immune system known as B cells and microglia. Targeting B cells helps control the acute inflammation that causes relapses, while targeting microglia inside the brain addresses the chronic damage that is thought to drive long-term disability progression. While most current BTK inhibitors are covalent and irreversible, meaning they form a permanent chemical bond with the enzyme, fenebrutinib is non-covalent and reversible, meaning it binds and then eventually releases the enzyme. About multiple sclerosis Multiple sclerosis is a chronic disease that affects more than 3 million people worldwide. People with all forms of multiple sclerosis experience disease progression from the beginning of their disease. Therefore, an important goal of treating multiple sclerosis is to slow, stop and ideally prevent progression as early as possible. Approximately 85% of people with multiple sclerosis are initially diagnosed with relapsing-remitting multiple sclerosis (RRMS). Relapsing forms of the disease (RMS) include RRMS and active secondary progressive MS, and people with RMS experience relapses and worsening disability over time. Primary progressive multiple sclerosis (PPMS) is a debilitating form of the disease marked by steadily worsening symptoms but typically without distinct relapses or periods of remission. Approximately 15% of people with multiple sclerosis are diagnosed with the primary progressive form of the disease. Until the FDA approval of Ocrevus®, there had been no FDA-approved treatments for PPMS, and Ocrevus is still the only approved treatment for PPMS. About Roche in Neurology Neurology is a major focus of research and development at Roche. Our goal is to pursue groundbreaking science to develop new diagnostics and treatments that help improve the lives of people with chronic and potentially devastating diseases globally. Roche is investigating more than a dozen medicines for neurological conditions, including multiple sclerosis, spinal muscular atrophy, neuromyelitis optica spectrum disorder, Alzheimer’s disease, Huntington’s disease, Parkinson’s disease and Duchenne muscular dystrophy. Roche Diagnostics has developed a broad range of approved and investigational tools, including digital and blood-based tests and cerebrospinal fluid (CSF) assays, aiming to more effectively detect, diagnose and monitor neurological conditions. Together with our partners, we are committed to pushing the boundaries of scientific understanding to solve some of the most difficult challenges in neurology today. About Roche Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions. Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them. Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law. References [1] Oh J, et al. Efficacy and Safety of Fenebrutinib vs Teriflunomide in Relapsing Multiple Sclerosis: Results of the FENhance 1 and 2 Studies. Presented at: 2026 American Academy of Neurology (AAN) Annual Meeting; April 21, 2026; Chicago, IL, USA, and virtual. [2] Bar-Or A, et al. Efficacy and Safety of Fenebrutinib vs Ocrelizumab in Primary Progressive Multiple Sclerosis: Primary Results of the Phase III FENtrepid Study. Presented at: Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2026; February 7, 2026; San Diego, CA, USA, and virtual. [3] MS International Federation. Atlas of MS. [Internet; cited September 2026]. Available from: https://atlasofms.org/map/global/epidemiology/number-of-people-with-ms  [4] Bittner S, Zipp F. Progression in multiple sclerosis - a long-term problem. Curr Opin Neurol. 2022;35(3):293-298. doi:10.1097/WCO.0000000000001044 [5] Bar-Or A, Dufek M, Budincevic H, et al. Safety and efficacy of fenebrutinib in relapsing multiple sclerosis (FENopta): a multicentre, double-blind, randomised, placebo-controlled, phase 2 trial and open-label extension study. Lancet Neurol. 2025;24(8):656-666. doi:10.1016/S1474-4422(25)00174-7 Roche Global Media Relations Phone: +41 61 688 88 88 / e-mail: media.relations@roche.com Tristan Schmitz Phone: +41 79 529 70 35Lorena Corfas Phone: +41 79 568 24 95 Simon Goldsborough Phone: +44 797 32 72 915Karsten Kleine Phone: +41 79 461 86 83 Kirti Pandey Phone: +41 79 398 38 53Yvette Petillon Phone: +41 79 961 92 50 Irène Stephan Phone:  +41 79 377 83 75Albert Thottiyil Phone: +41 79 775 66 12 Roche Investor Relations Dr Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.comDr Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com Dr Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com  Investor Relations North America Loren Kalm Phone: +1 650 225 3217 e-mail: kalm.loren@gene.com  Attachment Media & Investor Release Fenebrutinib FDA Filing English ———————————————————————————————————————————————————————————— Change in Roche’s Board of Directors 2026-09-23 · Roche · Biotech & pharma, Medical devices https://www.roche.com/media/releases/med-cor-2026-09-23 Roche announced today that the Board of Directors of Roche Holding Ltd has approved to propose Dr. Christophe Weber, former CEO of Takeda Pharmaceuticals, for election to the Board of Directors at Roche’s Annual General Meeting on March 9, 2027. Roche Chairman Severin Schwan: “I am pleased that we have been able to propose Christophe Weber for election to the Board of Directors. Christophe’s intimate knowledge of the healthcare industry and his broad leadership experience will further strengthen our Board.” About Roche Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions. Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceuticals Divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them. Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law.   Roche Global Media Relations Phone: +41 61 688 88 88 / e-mail: media.relations@roche.com Tristan Schmitz Phone: +41 79 529 70 35Lorena Corfas Phone: +41 79 568 24 95 Simon Goldsborough Phone: +44 797 32 72 915Karsten Kleine Phone: +41 79 461 86 83 Kirti Pandey Phone: +41 79 398 38 53Yvette Petillon Phone: +41 79 961 92 50 Irène Stephan Phone:  +41 79 377 83 75Albert Thottiyil Phone: +41 79 775 66 12 Attachment Media Release Change in BoD English ———————————————————————————————————————————————————————————— Stryker showcases Foot & Ankle innovation at AOFAS 2026 with Prophecy® Surgical Planning for Incompass™ and Hoffmann® LRF smartHEX™ 2026-09-16 · Stryker · Medical devices https://www.prnewswire.com/news-releases/stryker-showcases-foot--ankle-innovation-at-aofas-2026-with-prophecy-surgical-planning-for-incompass-and-hoffmann-lrf-smarthex-302879728.html New additions advance surgical planning, implant flexibility and connected care across Stryker's Foot & Ankle portfolio Stryker is launching... ———————————————————————————————————————————————————————————— Stryker introduces first of its kind FDA-authorized surgical application for Apple Vision Pro with hip arthroscopy case at nationally recognized academic medical center 2026-09-01 · Stryker · Healthcare, Medical devices https://www.prnewswire.com/news-releases/stryker-introduces-first-of-its-kind-fda-authorized-surgical-application-for-apple-vision-pro-with-hip-arthroscopy-case-at-nationally-recognized-academic-medical-center-302865215.html SportSuite Vision brings spatial computing into the operating room, providing surgeons access to critical clinical information Stryker announced the... ———————————————————————————————————————————————————————————— Stryker and IAGE partner to advance clinical excellence in fluorescence-guided surgery in gynaecology in India 2026-08-31 · Stryker · Healthcare, Medical devices https://www.prnewswire.com/in/news-releases/stryker-and-iage-partner-to-advance-clinical-excellence-in-fluorescence-guided-surgery-in-gynaecology-in-india-302864656.html Stryker, a global leader in medical technologies, announced a strategic partnership with the Indian Association of Gynaecological Endoscopists (IAGE) ... ———————————————————————————————————————————————————————————— Stryker spotlights the joint replacement journey and the vital role of caregivers at the 2026 BMW Championship 2026-08-17 · Stryker · Finance, Medical devices https://www.prnewswire.com/news-releases/stryker-spotlights-the-joint-replacement-journey-and-the-vital-role-of-caregivers-at-the-2026-bmw-championship-302852980.html What: Stryker will bring the caregiver experience in joint replacement to life at the 2026 BMW Championship, helping raise awareness of the vital... ———————————————————————————————————————————————————————————— Stryker expands Mako robotics portfolio with full market release of Mako RPS 2026-07-16 · Stryker · Finance, Healthcare, Medical devices https://www.prnewswire.com/news-releases/stryker-expands-mako-robotics-portfolio-with-full-market-release-of-mako-rps-302826896.html Stryker (NYSE: SYK), a global leader in medical technologies, announced today the U.S. commercial launch of Mako RPS® (Robotic Power System) for... ———————————————————————————————————————————————————————————— Stryker partners with professional golfer Shane Lowry to spotlight the caregiver journey in joint replacement 2026-06-24 · Stryker · Finance, Healthcare, Sports, Medical devices https://www.prnewswire.com/news-releases/stryker-partners-with-professional-golfer-shane-lowry-to-spotlight-the-caregiver-journey-in-joint-replacement-302808239.html Stryker (NYSE: SYK), a global leader in medical technologies, today announced a new partnership with Major Champion and globally recognized golfer... ———————————————————————————————————————————————————————————— Bayer completes acquisition of Perfuse Therapeutics 2026-06-17 · Bayer · Finance, SaaS, Healthcare, Biotech & pharma, Sustainability, Legal, Internet & apps, Medical devices https://www.bayer.com/media/en-us/bayer-completes-acquisition-of-perfuse-therapeutics/ Berlin, Germany, June 17, 2026 – Bayer today announced the completion of the acquisition of Perfuse Therapeutics, Inc. As a result, Perfuse Therapeutics will now be fully integrated into Bayer. As announced previously, Bayer now holds the full rights pertaining to PER-001 intravitreal implant, a first in class, sustained release small molecule endothelin receptor antagonist currently in Phase II clinical development for the treatment of Glaucoma and Diabetic Retinopathy (DR). This acquisition strengthens Bayer’s pharmaceutical pipeline and strategically fits with Bayer’s strong footprint and expertise in ophthalmology. Under the terms of the agreement, Bayer paid an upfront payment of USD 300 million. The transaction carries a total potential value of up to USD 2.45 billion, comprising of the upfront payment and additional success-based milestone payments. For Bayer, BofA Securities acted as exclusive financial advisor and Baker McKenzie acted as legal counsel. For Perfuse, Centerview Partners LLC acted as exclusive financial advisor and Goodwin Procter LLP acted as legal counsel. About Perfuse Therapeutics Perfuse Therapeutics is a biopharmaceutical company pioneering transformational research into the treatment of ischemia-induced ocular diseases. Enabled by its proprietary sustained-release drug delivery platform, the company is advancing its lead asset PER-001 for global leading causes of blindness. Headquartered in South San Francisco, Calif., and with R&D facilities in Durham, N.C., Perfuse Therapeutics has established a strong team committed to advancing disease-modifying therapies to patients with ocular disease around the world. About Bayer' Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to www.bayer.com. Find more information at https://pharma.bayer.com/ Follow us on Facebook: http://www.facebook.com/bayer Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires. Contact for media inquiries: Lisa Varrelmann, phone: +49 1746466492 Email: lisa.varrelmann@bayer.com Contact for investor inquiries:' Bayer Investor Relations Team, phone +49 214 30-72704 Email: ir@bayer.com' www.bayer.com/de/investoren/ir-team ———————————————————————————————————————————————————————————— Bayer’s low-dose MRI contrast agent approved in U.S. 2026-06-15 · Bayer · Healthcare, Media, Food & drink, Biotech & pharma, Sustainability, Internet & apps, Medical devices https://www.bayer.com/media/en-us/bayers-low-dose-mri-contrast-agent-approved-in-us/ Not intended for U.S. and UK Media   Bayer’s low-dose MRI contrast agent gadoquatrane approved in U.S.   Gadoquatrane from Bayer receives FDA approval for contrast-enhanced MRI to detect and visualize lesions with abnormal vascularity in the central nervous system and non-CNS body regions / Gadoquatrane becomes the lowest-dose macrocyclic gadolinium (Gd)-based contrast agent (mGBCA) approved in the U.S., with a recommended dose of 0.01 mmol/kg actual body weight, corresponding to 0.04 mmol Gd/kg body weight / Approval is supported by data from the Phase III QUANTI clinical studies, which demonstrated efficacy at a fraction of the dose compared to mGBCAs dosed at 0.1 mmol Gd/kg body weight / Gadoquatrane received its first approval in Japan in March 2026, further submissions to health authorities worldwide are ongoing to secure marketing authorization in additional markets Berlin, June 15, 2026 – Bayer today announced that the U.S. Food and Drug Administration (FDA) approved gadoquatrane, a new, intravenous macrocyclic gadolinium (Gd)-based contrast agent (mGBCA) under the brand name Ambelvist™. The product is indicated for contrast-enhanced magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in the central nervous system (CNS) and non-CNS body regions in adult and pediatric patients, including term neonates. Gadoquatrane is a next-generation mGBCA with a novel tetrameric structure and high relaxivity (a measure of signal enhancement). With this approval, gadoquatrane becomes the lowest dose mGBCA in the U.S. It has a recommended dose of 0.01 mmol/kg actual body weight (which corresponds to 0.04 mmol Gd/kg body weight), representing 60% less Gd compared to mGBCAs with a Gd content of 0.1 mmol Gd/kg body weight and 20% less Gd compared to gadopiclenol dosed at 0.05 mmol Gd/kg body weight. There is a rising need for medical imaging, driven by the increasing incidence of chronic diseases such as cancer and cardiovascular diseases. Contrast-enhanced MRI is a medical imaging examination often used by clinicians to gain insight into what’s happening in the human body and can play an important role in detecting abnormalities, monitoring disease progression and informing treatment decisions. For some adults and children with chronic diseases or conditions that require close, long-term monitoring – such as multiple sclerosis, other neurological or spinal conditions as well as different types of cancer – regular, repeat administrations may be required. “I often rely on contrast-enhanced MRI exams to inform clinical decision making,” said Dr. Christopher Hancock, Director of Neuroradiology at HALO Diagnostics Desert Cities, USA, and an investigator for the QUANTI clinical studies. “With this approval, we now have an additional option that can help deliver contrast-enhanced images at the lowest macrocyclic GBCA dose, reducing gadolinium exposure while preserving the clinical information we often need.” “Bayer is a leader in radiology and has played a pioneering role in MRI contrast agent development, having launched the first gadolinium-based contrast agent in 1988,” said Dr. Konstanze Diefenbach, Head of Radiology R&D at Bayer’s Pharmaceuticals Division. “With gadoquatrane – a next generation high-relaxivity, low-dose MRI contrast agent demonstrating high stability – we continue driving advances for patients and their treating physicians. Reducing patients’ lifetime exposure to gadolinium is an important consideration and reflects the growing clinical guidance to use the lowest gadolinium dose necessary to adequately image patients.” Gadoquatrane received its first approval in Japan in March 2026, and Bayer has submitted applications for marketing authorization in additional markets around the world, including the EU and China, with more to follow. Key Clinical Trial Findings The FDA’s approval is based on the global pivotal Phase III QUANTI clinical studies, which evaluated the efficacy and safety of gadoquatrane in adult and pediatric patients, including term neonates, undergoing contrast-enhanced MRI. Key findings demonstrated: ·         Increased lesion visualization with the combined pre-contrast and post-contrast MRI sets with the decreased Gd dose in gadoquatrane compared with only pre-contrast MRI images. ·         Visualization scores and number of lesions identified per blinded independent reader for gadoquatrane dosed at 0.01 mmol/kg body weight (which corresponds to 0.04 mmol Gd/kg body weight) were similar to mGBCAs with a Gd content of 0.1 mmol Gd/kg body weight. ·         Use in children is supported by evidence from adequate and well-controlled studies of gadoquatrane in adults, with additional pharmacokinetic and safety data from the pediatric study, including 93 patients aged 28 days to less than 18 years who received one 0.01mmol/kg dose and underwent MRI of any body region. About gadoquatrane Gadoquatrane is Bayer’s extracellular macrocyclic contrast agent for contrast enhancement in MRI. This low-dose gadolinium-based contrast agent features a distinct tetrameric structure with high stability and high relaxivity. The compound has been approved under the brand name Ambelvist™ in Japan in March 2026 and in the U.S. in June 2026. It has not been approved in any other jurisdiction. Bayer has submitted applications for marketing authorization of gadoquatrane in additional markets around the world. About MRI MRI is a non-invasive, radiation-free imaging method that provides detailed images of the body, helping to identify and distinguish potential abnormalities in organs and tissues. This supports physicians in answering critical medical questions related to the detection and monitoring of diseases. MRI contrast agents commonly contain gadolinium. For 2024, it is estimated that over 60 million doses of gadolinium-based contrast agents were administered worldwide. Cumulatively, since 1988, more than 900 million GBCA doses have been delivered globally. About Radiology at Bayer Building on a century of expertise, Bayer is committed to innovative products and high-quality services in diagnostic imaging to enhance patient care. Its leading radiology portfolio features contrast agents and devices for precise administration across modalities including computed tomography (CT), X-ray and magnetic resonance imaging (MRI), and positron emission tomography (PET). Bayer’s comprehensive offerings also include informatics solutions. In 2025, Bayer’s radiology products generated €2.2 billion in sales. Bayer continues to advance research and innovation in medical imaging, including in molecular imaging and other promising fields. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to www.bayer.com. Find more information at https://pharma.bayer.com/ Follow us on Facebook: http://www.facebook.com/bayer Follow us on Twitter: @BayerPharma Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires. Global contact for media inquiries: Victoria Vigener, phone +49 151 23438911 Email: victoria.vigener@bayer.com US contact for media inquiries: Elaine Colon, phone +1-732-236-1587 Email: elaine.colon@bayer.com Contact for investor inquiries: Bayer Investor Relations Team, phone +49 214 30-72704 Email: ir@bayer.com www.bayer.com/de/investoren/ir-team ———————————————————————————————————————————————————————————— Stryker launches TPX HD® power tool, supporting demanding orthopaedic procedures 2026-06-02 · Stryker · Finance, Healthcare, Medical devices https://www.prnewswire.com/news-releases/stryker-launches-tpx-hd-power-tool-supporting-demanding-orthopaedic-procedures-302787203.html Stryker (NYSE: SYK), a global leader in medical technologies, announced the launch of its TPX HD, a premium small bone power tool designed to support ... ———————————————————————————————————————————————————————————— Stryker and Max Smart Hospital, Saket Partner to Advance Surgeon Training and Education in Robotic-Arm Assisted Joint Replacement 2026-05-13 · Stryker · Healthcare, Education, Medical devices https://www.prnewswire.com/in/news-releases/stryker-and-max-smart-hospital-saket-partner-to-advance-surgeon-training-and-education-in-robotic-arm-assisted-joint-replacement-302770817.html Stryker, a global leader in medical technologies, and Max Smart Super Speciality Hospital, Saket, a leading healthcare provider in Delhi NCR,... ———————————————————————————————————————————————————————————— Bayer to acquire Perfuse Therapeutics to complement ophthalmology pipeline 2026-05-06 · Bayer · Finance, SaaS, Healthcare, Biotech & pharma, Sustainability, Legal, Internet & apps, Medical devices https://www.bayer.com/media/en-us/bayer-to-acquire-perfuse-therapeutics-to-complement-ophthalmology-pipeline/ Berlin, Germany and San Francisco, California USA, May 6, 2026 – Bayer and Perfuse Therapeutics Inc. today announced an agreement under which Bayer will fully acquire Perfuse Therapeutics, a biopharmaceutical company pioneering transformational research into the treatment of ischemia-induced ocular diseases. With this acquisition, Bayer will hold the full rights pertaining to PER-001, a small molecule endothelin receptor antagonist currently in Phase II clinical development for the treatment of Glaucoma and Diabetic Retinopathy (DR). This represents one of the first potential treatments for Glaucoma and DR being studied for its ability to improve the visual field for Glaucoma patients and to improve contrast sensitivity and reduce ischemia in DR patients. “We are excited by the work of the team at Perfuse Therapeutics and encouraged by the potential of PER-001,” said Juergen Eckhardt, M.D., Head of Business Development and Licensing at Bayer Pharmaceuticals. “With this acquisition, we are complementing our expertise in ophthalmology and our pipeline, reinforcing our commitment to developing urgently needed therapies for patients.”  “I’m incredibly proud of what the Perfuse team has accomplished and deeply thankful to all our investors and collaborators," said Sevgi Gurkan, MD, Founder and CEO of Perfuse Therapeutics, Inc. "Bayer’s vision aligns closely with ours, and they have the scale and global resources to unlock the full potential of PER-001 to change the trajectory of human blindness. We are very excited to see our mission continue with even greater momentum.” Glaucoma is a progressive optic neuropathy that causes the loss of retinal ganglion cells, resulting in loss of visual fields. It is the leading cause of irreversible vision loss1 affecting ~76-80 million people worldwide (2020) and is projected to affect ~112 million people by 2040 due to population aging.2 Despite its prevalence, there are no approved treatments today, preventing disease progression and blindness independently from the saturated approach of lowering intraocular pressure. There is a high unmet medical need for neuroprotective treatments for patients with Glaucoma. Diabetic Retinopathy (DR) is a microvascular complication of diabetes that damages retinal capillaries, causing ischemia, leakage, and neovascularization affecting about 146 million people globally today. This includes about 25 percent of adults with diabetes and is projected to increase to 160 million people by 2045. Currently, 25 million people have vision‑threatening DR and 1.3 million people are blind.3 Under the terms of the agreement, the transaction carries a total potential value of up to USD 2.45 billion, comprising a USD 300 million upfront payment and additional development, regulatory, and commercial milestone payments based on success criteria. For Bayer, BofA Securities is acting as exclusive financial advisor and Baker McKenzie is acting as legal counsel. For Perfuse, Centerview Partners LLC is acting as exclusive financial advisor and Goodwin Procter LLP is acting as legal counsel. The acquisition is subject to and will become effective after receiving the necessary antitrust clearances and Perfuse stockholder approvals. About PER-001 PER-001 is an investigational small molecule endothelin receptor antagonist being developed for the treatment of ophthalmic diseases. Endothelin is the most potent vasoconstrictor in the human body and is upregulated in glaucoma, diabetic retinopathy, age-related macular degeneration and retinal vein occlusion. Endothelin is involved in inflammation and cell death through its receptors expressed in retinal vascular and neuroretinal cells. The PER-001 intravitreal implant is a bio-erodible implant administered into the vitreous cavity of the eye using a single-use, 25-gauge applicator and designed to provide a sustained release of PER-001, allowing for a convenient dosing regimen. About Perfuse Therapeutics Perfuse Therapeutics is a biopharmaceutical company pioneering transformational research into the treatment of ischemia-induced ocular diseases. Enabled by its proprietary sustained-release drug delivery platform, the company is advancing its lead asset PER-001 for global leading causes of blindness. Headquartered in South San Francisco, Calif., and with R&D facilities in Durham, N.C., Perfuse Therapeutics has established a strong team committed to advancing disease-modifying therapies to patients with ocular disease around the world. For more information, visit www.perfusetherapeutics.com and LinkedIn. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to www.bayer.com. Find more information at https://pharma.bayer.com Follow us on Facebook: http://www.facebook.com/bayer Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires. 1 Vision Loss Expert Group of the Global Burden of Disease, 2024, Eye ² Sarkis et al., 2025, Frontiers in Med ³ WHO, 2019, World report on vision Executive Summary Bayer Global Media Contact: Lisa Varrelmann, phone +49 1746466492 Email: lisa.varrelmann@bayer.com Contact for investor inquiries: Bayer Investor Relations Team,  phone +49 214 30-72704 Email: ir@bayer.com www.bayer.com/de/investoren/ir-team Perfuse Therapeutics Media Contact: Perfuse Therapeutics Team Email: info@perfusetherapeutics.com Perfuse Therapeutics investor inquiries: Perfuse Therapeutics Team Email: info@perfusetherapeutics.com ———————————————————————————————————————————————————————————— Stryker Launches Trident II Acetabular System in India for Advancing Hip Replacement Surgeries 2026-04-30 · Stryker · Healthcare, Medical devices https://www.prnewswire.com/in/news-releases/stryker-launches-trident-ii-acetabular-system-in-india-for-advancing-hip-replacement-surgeries-302758337.html Stryker, a global leader in medical technologies, announced the launch of the Trident II Acetabular System in India. This advanced hip replacement...