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ALPMY FDA Decision Approved · 2025-11-21

Page updated November 5, 2026·next FDA decision on the calendar ·Data as of Nov 5, 2026 9:00 PM ET

Price into the decision (T-120)

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)4.7% median (n=312)

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 →

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 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.