Page updated ·next FDA decision on the calendar·Data as of Oct 14, 2026 7:39 PM ET
Price into the decision (T-120)
Daily close, T-120 (6/6/25) through T+5. Run-up high $27.37 on 10/3/25, low $23.12 on 6/10/25 (T-120 to T-1). FDA decision 11/21/25. Historical price action, not a forecast.
Positioning before the decision
On Nov 7, 2025, 14 days before the decision date, at-the-money options priced a move of ±4.7% through Nov 28, 2025 (the first listed expiry after the decision; ATM implied volatility 24%). The stock closed +2.6% at the first close across the decision and +5.5% 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.
Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.
Questions
Was PADCEV (enfortumab vedotin) approved by the FDA?
Yes. The FDA approved the application for PADCEV (enfortumab vedotin) on November 21, 2025, per the FDA's own record. The primary source is linked on this page.
What was PADCEV (enfortumab vedotin) under FDA review for?
The application covered Muscle-invasive bladder cancer (MIBC). The FDA approved the application on November 21, 2025.
How did PFE stock react to the FDA decision?
On the decision day PFE moved +2.6%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.