BAYRY PDUFA Date: Sevabertinib Updated August 20, 2026 ยท next FDA decision on the calendar FDA decision (PDUFA) target Nov 30, 2026 · Bayer · HER2-mutant NSCLC, 1L (sBLA, Priority Review)
Key facts FDA PDUFA target date 2026-11-30
Drug / candidate Sevabertinib
Indication HER2-mutant NSCLC, 1L (sBLA, Priority Review)
Company Bayer
Market-cap tier Large
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See the full 2026 PDUFA calendar → All November 2026 PDUFA dates → FAQ When is the BAYRY PDUFA date? The FDA PDUFA target date for BAYRY (Bayer) is 2026-11-30 for Sevabertinib. Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is BAYRY's drug Sevabertinib? Sevabertinib is Bayer's candidate under FDA review for HER2-mutant NSCLC, 1L (sBLA, Priority Review).
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