Finance · AI
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
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Attachments
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Media Investor Release Roche Q3 2026 English
Oct 22 · 05:00·Roche
Finance · Healthcare
Mountain View, CA, 21 Oct, 2026 - Unicycive Therapeutics, Inc. ("Unicycive" or the "Company") (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of its New Drug Application (NDA) for oxylanthanum carbonate (OLC), the Company's investigational oral phosphate binder for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. The NDA was resubmitted following a Complete Response Letter (CRL) received in June 2026. The FDA has deemed the OLC resubmission a Class II with a six-month review period from the resubmission date, and set a Prescription Drug User Fee Act (PDUFA) target action date of March 25, 2027.
Unicycive Therapeutics, Inc. is a B2i Digital Featured Company. See the company's in-depth profile at: https://b2idigital.com/unicycive-therapeutics.
"We are pleased that the FDA has accepted the resubmission of our NDA for OLC and assigned a PDUFA date," said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. "This resubmission includes CMC data from a new third-party drug product manufacturing vendor. The new vendor's facility was last inspected by the FDA in March 2024 and received 'No Action Indicated' status. We hope to continue working with the FDA toward potential approval of this important medication to patients with CKD on dialysis who need additional treatment options for managing hyperphosphatemia."
The Company does not know whether the FDA will decide to conduct a pre-approval inspection of the new third-party DP vendor. Additionally, if the original third-party manufacturing vendor is inspected in the near term and finds that its facility complies with current Good Manufacturing Practice (cGMP), the Company plans to seek FDA alignment on a shorter approval timeline.
The Company resubmitted the NDA following the second CRL, which cited deficiencies previously identified at the original third-party manufacturer of the drug product, which the FDA had not been able to re-inspect during the prior submission review.
The timing and outcome of any FDA inspection of the original third-party vendor will be determined solely by the FDA.
The NDA is supported by data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis), multiple preclinical studies, as well as CMC data. The FDA did not raise any concerns regarding OLC's preclinical or clinical data, including safety data, included in the original NDA submission.
About Oxylanthanum Carbonate
OLC is an investigational oral phosphate binder that leverages proprietary nanoparticle technology to deliver high phosphate binding potency, reducing the number and size of pills that patients must take to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden. Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. OLC is protected by a strong global patent portfolio including issued patents on composition of matter with exclusivity until 2031, and with the potential for patent term extension until 2035.
About Hyperphosphatemia
Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). Annually there are over 450,000 individuals in the U.S. that require medication to control their phosphate levels.[1] Uncontrolled hyperphosphatemia is strongly associated with increased death and hospitalization for CKD patients on dialysis. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.
[1] Flythe JE. Dialysis-Past, Present, and Future: A Kidney360 Perspectives Series. Kidney360. 2023 May 1;4(5):567-568. doi: 10.34067/KID.0000000000000145.
About Unicycive Therapeutics
Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive's lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding agent for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information, please visit Unicycive.com.
Forward-looking statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Unicycive's expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive's current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; Unicycive's clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; Unicycive's dependence on third parties for manufacturing; the possibility that FDA may require inspection of any vendor prior to approval, which could delay or prevent approval of its NDA; the risk that the inspection of the original or new third-party manufacturing vendor may not occur within a timeframe that benefits its regulatory timeline, or may result in adverse findings; risks related to business interruptions, which could seriously harm its financial condition and increase its costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; market acceptance of its products; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled 'Risk Factors' in Unicycive's Annual Report on Form 10-K for the year ended December 31, 2025, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
Investor Contacts:
Kevin Gardner, LifeSci Advisors, kgardner@lifesciadvisors.com
Media Contact:
Unicycive Therapeutics, media@unicycive.com
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SOURCE: Unicycive Therapeutics, Inc.
Oct 22 · 00:00·ACN Newswire