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MRK FDA Decision Approved · 2025-11-21

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 11/21/25$96.43$77.146/6/25
Daily close, T-120 (6/6/25) through T+5. Run-up high $96.43 on 11/18/25, low $77.14 on 6/6/25 (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 ±4.9% through Nov 28, 2025 (the first listed expiry after the decision; ATM implied volatility 26%). The stock closed +2.9% at the first close across the decision and +10.4% 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 date2025-11-21
DrugPADCEV (enfortumab vedotin) + KEYTRUDA (pembrolizumab) - (EV-303 / KEYNOTE-905)
IndicationMuscle-invasive bladder cancer (MIBC)
Outcome✓ Approvedprimary-sourced
Decision-day move+2.9%
T-120 run-up (low→high)+27.0% ($77.6→$100.4)
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.

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Questions

Was PADCEV (enfortumab vedotin) + KEYTRUDA (pembrolizumab) - (EV-303 / KEY approved by the FDA?

Yes. The FDA approved the application for PADCEV (enfortumab vedotin) + KEYTRUDA (pembrolizumab) - (EV-303 / KEY on November 21, 2025. The primary source is linked on this page.

What was PADCEV (enfortumab vedotin) + KEYTRUDA (pembrolizumab) - (EV-303 / KEY under FDA review for?

The application covered Muscle-invasive bladder cancer (MIBC). The FDA approved the application on November 21, 2025.

How did MRK stock react to the FDA decision?

On the decision day MRK moved +2.9%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.