Page updated ·next FDA decision on the calendar·Data as of Nov 5, 2026 9:00 PM ET
Price into the decision (T-120)
Daily close, T-120 (6/5/25) through T+5. Run-up high $8.7 on 10/1/25, low $7.12 on 6/6/25 (T-120 to T-1). FDA decision 11/20/25. Historical price action, not a forecast.
Decision facts
FDA decision date2025-11-20
DrugHYRNUO (sevabertinib)
IndicationHER2-Mutated Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer
Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.
Questions
Was HYRNUO (sevabertinib) approved by the FDA?
Yes. The FDA approved the application for HYRNUO (sevabertinib) on November 19, 2025, per the FDA's own record. The company announced it on November 20, 2025. The primary source is linked on this page.
What was HYRNUO (sevabertinib) under FDA review for?
The application covered HER2-Mutated Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer. The FDA approved the application on November 20, 2025.
How did BAYRY stock react to the FDA decision?
On the decision day BAYRY moved -1.2%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.