Announcement • 16h

Bayer Group Receives U.S. FDA Accelerated Approval For Sevabertinib As First-Line Treatment Option For Adults With HER2-Mutant Non-Small Cell Lung Cancer

Bayer Group has been 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 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-naive 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-naive patients with advanced HER2-mutant NSCLC. 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). 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. 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 naive 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.

Announcement • Sep 09

Bayer Initiates Phase II Study of Investigational Girk4 Inhibitor in Patients with Atrial Fibrillation

Bayer announced the initiation of a global Phase II clinical trial (NCT07625215) evaluating BAY 3670549, an investigational highly selective G-protein-coupled inwardly rectifying potassium channel 4 (GIRK4) inhibitor, which has the potential as a new approach to control the electrical activity of heart cells in patients with atrial fibrillation (AFib). The Phase II single-treatment study in a randomized, double-blind, placebo-controlled, parallel-group, multi-cohort design, will investigate the efficacy, safety and tolerability, as well as pharmacodynamics and pharmacokinetics of BAY 3670549 in adult patients with AFib. BAY 3670549 showed a generally favorable safety and tolerability profile in healthy participants in the completed first-in-human single-ascending-dose Phase I study, supporting its continued clinical advancement and strengthening Bayer’s cardiovascular development portfolio. BAY 3670549, which emerged from Bayer’s strategic research alliance with the Broad Institute, is being investigated as a novel approach for rapid cardioversion to normal sinus rhythm. If successful, it could provide a potential alternative to electrical cardioversion, the current gold standard for AFib. BAY 3670549 is an investigational highly selective G-protein-coupled inwardly rectifying potassium channel 4 (GIRK4) inhibitor being evaluated as a potential new approach to help control the electrical activity of heart cells in patients with atrial fibrillation (AFib). GIRK4 channels are specialized proteins that regulate the electrical activity of heart cells by facilitating the flow of potassium ions (K+) in response to the neurotransmitter acetylcholine (ACh). This mechanism is particularly crucial during the later phases of the heart’s electrical signaling, specifically during the atrial effective refractory period (AERP). Increased activity of these channels shortens the AERP in the atria (the upper chambers of the heart), thereby reducing the recovery time after each heartbeat. This alteration in recovery time can contribute to the onset and persistence of AFib. A placebo-controlled, parallel-group, double blind, randomized, multi-cohort Phase II study will investigate efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics of BAY 3670549 in adult participants with AFib. The study will compare BAY 3670549 to a placebo in patients with AFib who need a treatment called electrical cardioversion. Electrical cardioversion is a procedure that helps the heart return to a normal rhythm. In the Phase I study, BAY 3670549 was generally well-tolerated in healthy male and female participants.

Bayer Aktiengesellschaft Stock Price

BAYN Share Price Performance

BAYN Community Narratives

Crop Science And Pharmaceuticals Will Thrive On Favorable Trends

Sustainable Farming And Rising Healthcare Will Fuel Expansion

Crop Science And Pharmaceuticals Will Suffer Under Mounting Liabilities

Bayer to Achieve Fair Value of €40 Boosting Growth and Investor Confidence

Crop Science And Pharmaceuticals Will Thrive On Favorable Trends

Sustainable Farming And Rising Healthcare Will Fuel Expansion

Crop Science And Pharmaceuticals Will Suffer Under Mounting Liabilities

Trending Discussion

Recently Updated Narratives

Bayer to Achieve Fair Value of €40 Boosting Growth and Investor Confidence

BAYN: Glyphosate Settlement Clarity Will Drive Future Re Rating Potential

BAYN: Glyphosate Litigation Resolutions Will Drive Future Rerating Potential

Snowflake Analysis

Bayer Aktiengesellschaft Key Details

About BAYN

Recent BAYN News & Updates

FDA Grants Accelerated Approval to Bayer’s HYRNUO for HER2-Mutated Lung Cancer Treatment

Bayer Group Receives U.S. FDA Accelerated Approval For Sevabertinib As First-Line Treatment Option For Adults With HER2-Mutant Non-Small Cell Lung Cancer

Bayer Initiates Phase II Study of Investigational Girk4 Inhibitor in Patients with Atrial Fibrillation

Recent updates

Bayer Aktiengesellschaft Competitors

Merck KGaA

SCHOTT Pharma KGaA