Daily close, T-120 (3/12/25) through T+5. Run-up high $100.54 on 4/29/25, low $86.65 on 4/14/25 (T-120 to T-1). FDA decision 8/27/25. Historical price action, not a forecast.
Positioning before the decision
On Aug 13, 2025, 14 days before the decision date, at-the-money options priced a move of ±9.4% through Sep 19, 2025 (the first listed expiry after the decision; ATM implied volatility 36%). The stock closed -1.7% at the first close across the decision and -4.2% five trading days on. A straddle priced weeks out covers ordinary movement plus the event, so this is the move the options market priced through that expiry, not the event-implied move alone. How this compares across 1,000+ decisions.
Decision facts
FDA decision date2025-08-27
DrugCOMIRNATY LP.8.1
IndicationHigh risk for severe outcomes from COVID-19
Yes. The FDA approved the application for COMIRNATY LP.8.1 on August 27, 2025. The primary source is linked on this page.
What was COMIRNATY LP.8.1 under FDA review for?
The application covered High risk for severe outcomes from COVID-19. The FDA approved the application on August 27, 2025.
How did BNTX stock react to the FDA decision?
On the decision day BNTX moved -1.7%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.