PADCEV (enfortumab vedotin-ejfv) plus Keytruda approved as neoadjuvant and adjuvant treatment for muscle-invasive bladder cancer, regardless of cisplatin eligibility (Jul 10 2026).
Run-up into the decision (T-120 → T+5)
Daily close, T-120 (1/15/26) through T+3. Run-up high $28.55 on 4/1/26, low $23.67 on 6/25/26 (T-120 to T-1). FDA decision 7/10/26. Historical price action, not a forecast.
Key facts
FDA decision date2026-07-10
OutcomeApproved
Drug / candidateKEYTRUDA (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) - (KEYNOTE-B15/EV-304)
IndicationMuscle-invasive bladder cancer (MIBC)
CompanyPfizer Inc.
Market-cap tierLarge
120-day run-up (T-120→T-1)-6.3%
Cohort decision-day move (history)±1% median
The PDUFA goal date was August 17, 2026 for the cisplatin-eligible population, based on the Phase 3 KEYNOTE-B15 trial (also known as EV-304). The FDA approved on July 10, 2026, about five weeks early. PADCEV is partnered between Pfizer and Astellas.
Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier — history, not a prediction.