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BAYRY FDA Decision Approved · 2025-11-20

Updated September 23, 2026·next FDA decision on the calendar

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

Outcome✓ Approvedprimary-sourced

Decision-day move-1.2%

T-120 run-up (low→high)+9.0% ($7.25→$8.7)

ValidationVerified 2026-08-12: Drugs@FDA, application NDA219972, action date 2025-11-19

Market-cap tierLarge

Cohort decision-day move (history)1.0% median (n=835)

Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.

See the full 2026 PDUFA calendar →

Questions

Was HYRNUO (sevabertinib) approved by the FDA?

Yes. The FDA approved the application for HYRNUO (sevabertinib) 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.