We use cookies to understand how you use our site and to improve your experience.
This includes personalizing content and advertising.
By pressing "Accept All" or closing out of this banner, you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties.
You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
In addition, whether you "Accept All," Deny Optional," click the X or otherwise continue to use the site, you accept our Privacy Policy and Terms of Service, revised from time to time.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
FDA Grants Priority Tag to Bayer's Oncology Drug for First-Line NSCLC
Read MoreHide Full Article
Key Takeaways
BAYRY secures FDA priority review for sevabertinib in first-line HER2-mutant NSCLC.
Bayer's filing is backed by phase I/II SOHO-01 data in untreated advanced NSCLC patients.
Sevabertinib already has U.S. accelerated approval for previously treated HER2-mutant NSCLC.
Bayer (BAYRY - Free Report) 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 Research
More on Bayer’s Sevabertinib
Sevabertinib 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.
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%.
Zacks' 7 Best Strong Buy Stocks (New Research Report)
Valued at $99, click below to receive our just-released report
predicting the 7 stocks that will soar highest in the coming month.
View the Zacks #1 Rank List
Image: Bigstock
FDA Grants Priority Tag to Bayer's Oncology Drug for First-Line NSCLC
Key Takeaways
Bayer (BAYRY - Free Report) 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 Research
More on Bayer’s Sevabertinib
Sevabertinib 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 Consider
BAYRY currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the biotech sector are Immunocore (IMCR - Free Report) , Indivior Pharmaceuticals (INDV - Free Report) and Liquidia Corporation (LQDA - Free Report) , 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%.