Bayer BAYRY announced that the FDA has granted approval to sevabertinib through an accelerated pathway for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD)-activating mutations.
Year to date, BAYRY’s shares have risen 32.2% compared with the industry’s 10.6% growth.
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SOHO-01 Data Support Sevabertinib’s Use in First-Line NSCLC
The regulatory approval for sevabertinib in first-line patients with locally advanced or metastatic HER2-mutant NSCLC was based on data from the ongoing phase I/II SOHO-01 study. The study data demonstrated that treatment with sevabertinib achieved a strong 75% objective response rate (ORR), including complete responses in 6% of patients and partial responses in 70%. Among those who responded, 73% maintained their response for at least six months. The drug’s safety profile was also consistent with findings from earlier studies.
Bayer is conducting the phase III SOHO-02 confirmatory study evaluating sevabertinib versus standard treatment in previously untreated patients with advanced HER2-mutant NSCLC. Positive data could help support conversion of accelerated approval into traditional approval in the United States.
Sevabertinib originated from Bayer’s research collaboration with the Broad Institute of MIT and Harvard.
In November 2025, the FDA granted accelerated approval to sevabertinib under the brand name Hyrnuo for previously treated patients with advanced HER2-mutant NSCLC.
The drug received approval in China as a monotherapy for adults with unresectable, locally advanced or metastatic HER2-mutant NSCLC who have received at least one prior systemic therapy. It is also approved in Japan for HER2-mutant NSCLC regardless of treatment line, including first-line use.
A broad clinical program is underway to expand sevabertinib’s use across lines of therapy and tumor types. In addition to the SOHO-01 study and the phase III SOHO-02 study, sevabertinib is being evaluated in the panSOHO study in HER2-mutated solid tumors outside advanced NSCLC.
In December 2025, the FDA granted Breakthrough Therapy designation to sevabertinib for the first-line treatment of patients with HER2-mutant NSCLC.
Bayer Advances BAY 3670549 Into Phase II Study for AFib
In a separate press release, Bayer declared that it has initiated a global phase II study evaluating BAY 3670549, an investigational, highly selective GIRK4 inhibitor, for the treatment of patients with atrial fibrillation (AFib).
AFib is a common heart rhythm disorder in which the heart’s upper chambers beat rapidly and irregularly, disrupting normal blood flow and increasing the risk of blood clots and stroke. Its prevalence is rising globally, with cases projected to reach 15.9 million in the United States by 2050 and 17.9 million in Europe by 2060.
The study will compare BAY 3670549 to a placebo in AFib patients who require electrical cardioversion, the current gold standard for AFib. Electrical cardioversion is a procedure that helps the heart return to a normal rhythm. If successful, BAY 3670549 could provide a fast-acting and well-tolerated treatment option that may help reduce the burden on both patients and healthcare systems by offering an alternative to electrical cardioversion.
BAY 3670549 showed a favorable safety and tolerability profile in the completed phase I first-in-human study, supporting its advancement to phase II. The program originated from Bayer’s strategic research alliance with the Broad Institute of MIT and Harvard and added another potential growth opportunity to Bayer’s cardiovascular pipeline.
Bayer’s Zacks Rank & Stocks to Consider
BAYRY currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Precigen PGEN, currently sporting a Zacks Rank #1 (Strong Buy), and AC Immune ACIU and Aldeyra Therapeutics ALDX, carrying a Zacks Rank #2 (Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have improved from a loss of 2 cents to earnings per share of 25 cents. Over the same period, earnings estimates for 2027 have risen from 25 cents to 86 cents. PGEN shares have increased 62.7% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 108.96%.
Over the past 60 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents. ACIU shares have lost 12.1% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.
Over the past 60 days, loss per share estimates for Aldeyra Therapeuticshave narrowed from 43 cents to 39 cents for 2026. Over the same period, estimates for 2027 loss per share have narrowed from 22 cents to 16 cents. ALDX shares have plunged 71.1% year to date.
Aldeyra Therapeutics’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 29.25%.
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Bayer Aktiengesellschaft (BAYRY): Free Stock Analysis Report
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This article originally published on Zacks Investment Research (zacks.com).