Daily close, T-120 (5/12/25) through T+5. Run-up high $90.13 on 10/1/25, low $73.47 on 5/20/25 (T-120 to T-1). FDA decision 10/27/25. Historical price action, not a forecast.
Positioning before the decision
On Oct 13, 2025, 14 days before the decision date, at-the-money options priced a move of ±6.3% through Oct 31, 2025 (the first listed expiry after the decision; ATM implied volatility 35%). The stock closed +0.6% at the first close across the decision and -1.7% 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 date2025-10-27
DrugWINREVAIR (sotatercept-csrk) - (ZENITH)
IndicationPulmonary arterial hypertension (PAH, WHO* Group 1)
Was WINREVAIR (sotatercept-csrk) - (ZENITH) approved by the FDA?
Yes. The FDA approved the application for WINREVAIR (sotatercept-csrk) - (ZENITH) on October 27, 2025. The primary source is linked on this page.
What was WINREVAIR (sotatercept-csrk) - (ZENITH) under FDA review for?
The application covered Pulmonary arterial hypertension (PAH, WHO* Group 1). The FDA approved the application on October 27, 2025.
How did MRK stock react to the FDA decision?
On the decision day MRK moved +0.6%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.