FDA Grants Priority Tag to Bayer's Oncology Drug for First-Line NSCLC

Bayer BAYRY announced that the FDA has granted priority review to sevabertinib 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.Sevabertinib is a new oral, reversible small-molecule tyrosine kinase inhibitor (TKI) designed to selectively target mutant HER2, including HER2 exon 20 insertion and HER2 point mutations, along with epidermal growth factor receptors (EGFR), while showing high selectivity for mutant EGFR over the wild-type form.A Priority Review designation means the FDA’s goal is to take action on an application within six months compared with 10 months under standard review.The FDA grants priority review to therapies that, if approved, are expected to offer significant improvements in the safety or effectiveness of treating, diagnosing or preventing serious conditions.The regulatory submission for first-line use of sevabertinib is based on preliminary clinical data from cohort F of the ongoing phase I/II SOHO-01 study which is evaluating the safety and efficacy of sevabertinib in previously untreated patients with locally advanced or metastatic HER2-mutant NSCLC.Year to date, BAYRY shares have risen 1.9% against the industry’s 2% decline.Image Source: Zacks Investment ResearchMore on Bayer’s SevabertinibSevabertinib originated from Bayer’s research collaboration with the Broad Institute of MIT and Harvard.The FDA granted accelerated approval to sevabertinib under the brand name Hyrnuo, in November 2025, for previously treated patients with advanced HER2-mutant NSCLC, based on objective response rate and duration of response data from cohorts D and E of the SOHO-01 study.The drug has 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.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, sevabertinib is being evaluated across multiple studies, including the phase III SOHO-02 study in treatment-naïve HER2-mutant NSCLC and the panSOHO study in HER2-mutated solid tumors outside advanced NSCLC.In December, the FDA granted Breakthrough Therapy designation to sevabertinib for the first-line treatment of patients with HER2-mutant NSCLC.Bayer’s Zacks Rank & Other Stocks to ConsiderBAYRY currently carries a Zacks Rank #2 (Buy).Some other top-ranked stocks in the biotech sector are Immunocore IMCR, Indivior Pharmaceuticals INDV and Liquidia Corporation LQDA, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.Over the past 60 days, estimates for Immunocore’s 2026 loss per share have narrowed from 97 cents to 16 cents. Over the same period, estimates for 2027 have improved from a loss of 39 cents to earnings of 11 cents per share. IMCR shares have lost 18.3% year to date.Immunocore’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 46.66%.Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have increased from $3.03 to $3.35. Over the same period, EPS estimates for 2027 have risen to $3.69 from $3.46. INDV shares have risen 1.8% year to date.Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%.Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have increased to $2.97 from $1.50. Over the same period, EPS estimates for 2027 have risen to $4.81 from $2.91. LQDA shares have gained 65.2% year to date.Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.Beyond Nvidia: AI's Second Wave Is HereThe AI revolution has already minted millionaires. But the stocks everyone knows about aren't likely to keep delivering the biggest profits. AI’s second wave is moving from infrastructure to implementation and these companies are at the forefront of this transition, positioned to become what Amazon and Google were to the internet era.See Stocks Now >>This article originally published on Zacks Investment Research (zacks.com).Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks