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Finance · Healthcare
CHICAGO and FORT WORTH, Texas, Sept. 09, 2026 -- Actuate Therapeutics, Inc. (NASDAQ: ACTU) (“Actuate” or the “Company”), a clinical-stage biopharmaceutical company, focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers, today announced that it will present at the H.C. Wainwright 28th Annual Global Investment Conference taking place September 14-16, 2026, in New York City. In addition, the management team will be available for one-on-one meetings during the conference.
Sep 9 · 21:00·GlobeNewswire
Finance · Healthcare
SAN FRANCISCO, Sept. 9, 2026 -- Hagens Berman Sobol Shapiro LLP alerts investors in Regeneron Pharmaceuticals (NASDAQ: REGN) that a securities class action lawsuit has been filed after its surprising revelations concerning a Phase 3 clinical trial of a therapy intended to...
Sep 9 · 20:59·PR Newswire
Finance · Healthcare
PARIS and CAMBRIDGE, Mass., Sept. 09, 2026 -- NANOBIOTIX (Euronext: NANO - NASDAQ: NBTX - the “Company”), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer and other major diseases, today announced that Company management will participate in a fireside chat at the following investment conference:
Sep 9 · 20:15·GlobeNewswire
Finance · Healthcare
WALTHAM, Mass., Sept. 09, 2026 -- Crescent Biopharma, Inc. (“Crescent” or the “Company”) (Nasdaq: CBIO), a clinical-stage biotechnology company dedicated to rapidly advancing the next wave of therapies for cancer patients, today announced that the independent Compensation Committee of its Board of Directors approved the grant of options to purchase an aggregate of 58,650 shares of the Company’s ordinary shares to two non-executive employees as equity inducement awards under the Crescent Biopharma, Inc. 2025 Employment Inducement Incentive Award Plan, as amended (the “Inducement Plan”). The options were approved on September 8, 2026 and were material to each employee's acceptance of employment with Crescent, in accordance with Nasdaq Listing Rule 5635(c)(4).
Sep 9 · 20:15·GlobeNewswire
Finance · Healthcare
NEW YORK, Sept. 09, 2026 -- Royalty Pharma plc (Nasdaq: RPRX) today announced that it will participate in the following upcoming investor conferences during the month of September:
Sep 9 · 20:05·GlobeNewswire
Healthcare · Automotive
Berlin, September 9, 2026 – Following Priority Review and Breakthrough Therapy Designation, the U.S. Food and Drug Administration (FDA) has granted accelerated approval for sevabertinib as a first-line treatment option for adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have human epidermal growth factor receptor 2 (HER2/ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test. Sevabertinib is an oral, reversible, small molecule, tyrosine kinase inhibitor (TKI).
“The FDA’s accelerated approval of sevabertinib marks an important advance for treatment-naïve patients with HER2-mutated NSCLC who historically have a poor prognosis,” said SOHO-01 lead investigator, Xiuning Le, MD, PhD, associate professor of Thoracic/Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center, Houston, Texas. “This milestone also underscores the critical importance of comprehensive molecular testing at diagnosis, including for activating HER2 mutations, to ensure patients receive the most appropriate treatment as early as possible.”
The FDA approved this indication for sevabertinib under accelerated approval based on objective response rate (ORR) and duration of response (DOR) demonstrated in a cohort of treatment-naïve patients (N=69) in the ongoing Phase I/II SOHO-01 trial (NCT05099172), evaluating the efficacy and safety of sevabertinib in patients with locally advanced or metastatic HER2-mutant NSCLC. In this cohort, the ORR was 75% including complete responses in 6% of patients and partial responses in 70% of patients, with 73% of responders maintaining response for at least six months. The safety profile of sevabertinib was consistent with previous findings. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the ongoing Phase III SOHO-02 confirmatory trial (NCT06452277), which is evaluating sevabertinib versus standard of care in treatment-naïve patients with advanced HER2-mutant NSCLC.
“Today’s FDA approval of sevabertinib as an initial treatment option for locally advanced or metastatic non-squamous HER2-mutated NSCLC is an important milestone for patients and a powerful validation of Bayer’s commitment to advancing precision oncology in areas with the highest unmet needs,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. “Lung cancer remains the leading cause of cancer-related deaths worldwide and for patients with HER2-mutated NSCLC, a distinct subtype that often affects people who have never smoked, there remains a critical need for additional treatment options. This approval underscores the potential of precision medicine to transform outcomes by matching the right patients to the right therapy at the right time.”
In November 2025, sevabertinib received FDA accelerated approval for patients with previously treated advanced HER2-mutant NSCLC based on objective response rate (ORR) and duration of response (DOR) data from the SOHO-01 trial (from cohort D - previously treated patients who had not received HER2-targeted therapy and cohort E - patients who had previously received HER2-directed antibody-drug conjugates). Earlier this year, sevabertinib was also approved by the National Medical Products Administration (NMPA) in China as monotherapy in adult patients with unresectable, locally advanced or metastatic NSCLC whose tumors have HER2 activating mutations, and who have received one prior systemic therapy. The approval follows the Center for Drug Evaluation (CDE) in China granting sevabertinib Breakthrough Therapy Designation for this patient population. The CDE has also granted sevabertinib Breakthrough Therapy Designation to expedite its development for first-line use in patients with advanced HER2-mutant NSCLC. Sevabertinib has also recently been approved as the first approved targeted therapy for this indication that can be used regardless of line of therapy, including as a first-line treatment, by the Ministry of Health, Labour, and Welfare in Japan.
About sevabertinib
Sevabertinib is a new, oral, reversible, small molecule, tyrosine kinase inhibitor (TKI) that potently inhibits mutant human HER2, including HER2 exon 20 insertions and HER2 point mutations. Sevabertinib works by blocking certain enzymes called tyrosine kinases, which are involved in the growth of cancer cells. Reversible TKIs can temporarily block their targets, allowing for more precise control over treatment and potentially reducing long-term side effects compared to irreversible TKIs. Sevabertinib is derived from Bayer’s strategic research alliance with the Broad Institute of MIT and Harvard in Cambridge, MA, USA.
As part of its clinical development program, alongside the SOHO-01 trial, sevabertinib is also being studied in the Phase III SOHO-02 trial (NCT 06452277) evaluating sevabertinib in treatment naïve patients with HER2-mutant NSCLC and in the panSOHO study (NCT06760819) in patients with metastatic or unresectable solid tumors with HER2-activating mutations, excluding advanced NSCLC.
About Non-Small Cell Lung Cancer (NSCLC)
Lung cancer is the leading cause of cancer-related deaths worldwide. NSCLC is the most common type of lung cancer, accounting for more than 85% of cases. Activating HER2 mutations are found in 2% to 4% of patients with advanced NSCLC. 80% of people diagnosed with NSCLC have already progressed to advanced stages, which makes it more difficult to treat. Patients with HER2-mutant NSCLC currently face limited treatment options, highlighting an urgent need for more effective therapies.
About Oncology at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The company has the passion and determination to develop new medicines that help improve and extend the lives of people living with cancer. The oncology franchise at Bayer includes several marketed products across diverse indications and multiple compounds in different stages of clinical development. We have a wealth of expertise in areas including: Tumor Intrinsic Pathways, Targeted Radionuclide Therapies, and Next-Generation Immuno-Oncology. We are advancing prostate cancer treatment from early to metastatic stage, with the goal of extending survival while limiting side effects. Part of Bayer’s focus on innovative precision oncology treatments, includes an approved TRK inhibitor exclusively designed to treat tumors that have an NTRK gene fusion, the oncogenic driver of tumor growth and spread.
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.
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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.
Sep 9 · 18:20·Bayer
Biotech & pharma
LOS ANGELES, Sept. 9, 2026 -- The Law Offices of Frank R. Cruz announces that investors with losses related to Unicycive Therapeutics, Inc. (UNCY) have opportunity to lead the securities fraud class action lawsuit. IF YOU ARE AN INVESTOR WHO SUFFERED A LOSS IN UNICYCIVE...
Sep 9 · 18:15·PR Newswire
Healthcare · Food & drink
WALTHAM, Mass., Sept. 09, 2026 -- Sobi North America, the North American affiliate of Swedish Orphan Biovitrum AB (Sobi®), today announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to pacritinib for the treatment of VEXAS syndrome. Pacritinib is a dual IRAK1/JAK2 inhibitor currently in Phase ll development for VEXAS syndrome.
Sep 9 · 17:50·GlobeNewswire
Biotech & pharma
CHICAGO, Sept. 09, 2026 -- Quetzal Therapeutics, a biopharmaceutical company focused on developing therapies for rare diseases, including hematologic malignancies, today announced the appointment of Harindra R. Abeysinghe, Ph.D., as Chief Regulatory and Quality Officer.
Sep 9 · 15:03·GlobeNewswire
AI · Biotech & pharma
Nature publication validates Apeximmune's novel target and reveals an enzyme-independent mechanism the field had overlooked; company's first-in-class anti-PLA2G2D antibody AI-306 advancing toward IND filing in Q2 2027 SOUTH SAN FRANCISCO, Calif., Sept. 9, 2026 -- Apeximmune...
Sep 9 · 15:02·PR Newswire
Healthcare · Biotech & pharma
Press release – No. 15 / 2026
Sep 9 · 15:00·GlobeNewswire
Finance · AI
HONG KONG, Sept 9, 2026 - China’s No.1 cognitive digital therapeutics company - BrainAurora Medical Technology Limited (“BrainAu”)(Stock code:06681.HK) is pleased to announce that the Company’s scientific research team and the team of Professor Ni Xin from Beijing Children’s Hospital, Capital Medical University has jointly published the research titled “Optimal doses of cognitive digital therapeutics for pediatric patients with cognitive impairments: A retrospective study based on big data” in BMC Medicine (2025 Journal Impact Factor: 8.7), a top international comprehensive medical journal.
This study is China's first large-scale real-world big data study based on the BrainAu’s AI cognitive digital therapeutics, which defines age- and sex-specific optimal digital training doses for pediatric patients with cognitive impairment. Its conclusions clearly indicate that trainees achieved significant improvement only when daily training exceeded 8 minutes, with 16 to 20 minutes per day corresponding to the highest cognitive performance, representing the optimal daily dose for the overall population. Beyond this range, further extending daily training duration did not yield additional significant benefits.
The result findings of the real-world big data study provide strong evidence for individualized precise cognitive digital therapeutic interventions and serve as a reference for the formulation of future treatment guidelines.
Real-world Big Data Helps Define Future Cognitive Training Dosages
As a retrospective study based on real-world big data, this study included 38,526 children and adolescents (aged from 3 to 18 years) with cognitive impairment who used the BrainAu’s “Brain Function Information Management Platform Software System” (Class II medical device, Registration Certificate No.: Xiang Xie Zhu Zhun 20182210142) and completed at least two weeks of training between 2021 and 2025, systematically characterized the dose-response relationship across three dimensions: daily training duration, weekly training frequency, and total training cycle. The platform contains 123 tasks adapted from classic paradigms, covering four major cognitive domains, namely perception, attention, memory, and executive function. The Mean Cognitive Index (MCI) adopted by the study as the primary outcome measure reflects comprehensive task performance during training.
The study achieved the following positive and outstanding result findings, including:
Optimal daily dose for the overall population: with 0 to 4 minutes per day as the baseline, significant improvement was observed only when daily training exceeded 8 minutes, with 16 to 20 minutes per day corresponding to the highest cognitive performance, representing the optimal daily dose for the overall population. Beyond this range, further extending daily training duration did not yield additional significant benefits.
Age-and sex-stratified differences: the four subgroups demonstrated different optimal daily doses and total doses:
Age Group
Gender
Optimal Daily Dose
Optimal Total Dose
<10 years old
Male
16 to 20 minutes/day
6 to 7 months
<10 years old
Female
24 to 28 minutes/day
8 to 9 months
≥10 years old
Male
20 to 24 minutes/day
4 to 5 months
≥10 years old
Female
16 to 20 minutes/day
1 to 2 months
Weekly training frequency: the highest cognitive performance across all four subgroups was observed with 7 days of training per week; for most subgroups, significant improvement was observed only when training was conducted on at least 5 days per week.
Total intervention cycle: regardless of age and gender, children who received training for more than 1 month demonstrated significant cognitive improvement compared to those who received training for less than 1 month.
Reference: Liu Y, Liang S, Liang A, et al. Optimal doses of cognitive digital therapeutics for pediatric patients with cognitive impairments: A retrospective study based on big data. BMC Medicine. 2026. DOI: 10.1186/s12916-026-05080-8.
Mr. Tan Zheng, Chairman of BrainAu, concluded: “We are delighted that, through the joint efforts of our scientific research team and the team of Professor Ni Xin from Beijing Children’s Hospital, Capital Medical University, we have provided outstanding research findings based on real-world big data for the continuous optimization of personalized digital cognitive therapeutics for pediatric patients with cognitive impairments worldwide. Based on real-world data of 38,526 children, this study systematically defined for the first time the optimal digital training doses for different ages and genders, filled the research gap in the dose-response relationship in the field of pediatric cognitive digital therapeutics and provided an evidence-based foundation for individualized precise intervention. The publication of these findings in the top international comprehensive medical journal BMC Medicine reflects the Group’s leading capabilities in the field of large-scale real-world data research on cognitive digital therapeutics, thereby further expanding the Group’s evidence-based landscape for digital therapeutics to cover diverse populations such as pediatric cognitive impairment. At the same time, this study also fully reflects the ongoing deepening of the Group’s “industry-academia-research-medicine” integration model shall continue to reinforce our underlying scientific-research and evidence-based medicine capabilities underpinning the Group’s long-term development strategy, as well as will further consolidate the Group’s industry-leading position in digital therapeutics for cognitive impairment and digital therapeutics for pediatric diseases, creating long-term value to shareholders.”
About BrainAurora Medical Technology Limited
BrainAurora Medical Technology Limited (“BrainAu”, HKEX : 06681.HK) was founded in 2012 and listed on the Main Board of Hong Kong Stock Exchange in 2025. BrainAu is a seasoned player in China’s cognitive impairment digital therapeutics (the “DTx”) market and is the first company in China that has developed a medical-grade DTx product for cognitive impairment, combining brain science with advanced artificial intelligence (the “AI”) technologies. The Company’s product pipeline covers both the assessment and intervention of a broad range of cognitive impairments induced by vascular diseases, neurodegenerative diseases, psychiatric disorders, and child development deficiencies, among others. The Company’s core product, namely the Brain Function Information Management Platform Software System is the first cognitive impairment DTx product that has obtained regulatory approval in China. As of the date of 30 June 2026, the core product had been included in the provincial health insurance reimbursement lists of 30 provinces in China.
For more information, please visit https://www.66nao.cn
Sep 9 · 14:21·ACN Newswire