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Home › FDA Decisions › ALPMY 2025-11-21

ALPMY FDA Decision Approved · 2025-11-21

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 11/21/25$12.43$9.236/6/25
Daily close, T-120 (6/6/25) through T+5. Run-up high $12.43 on 11/20/25, low $9.23 on 6/24/25 (T-120 to T-1). FDA decision 11/21/25. Historical price action, not a forecast.

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+1.0%
T-120 run-up (low→high)+29.0% ($9.69→$12.6)
ValidationVerified 2026-08-12: Drugs@FDA, application BLA761137, action date 2025-11-21
Market-cap tierMicro
Cohort decision-day move (history)4.6% median (n=308)

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 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 ALPMY stock react to the FDA decision?

On the decision day ALPMY moved +1.0%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.