pdufa.bio
HomePDUFA Calendar › BNTX

BNTX PDUFA date: KEYTRUDA (pembrolizumab) + Padcev

26 business days to decision · 2026-08-17

Merck's KEYTRUDA (pembrolizumab) + Padcev for Perioperative muscle-invasive bladder cancer (sBLA) — FDA decision expected August 17, 2026.

Run-up into the PDUFA

PDUFA 8/17/26today$111.6$83.89
Daily close so far, T-120 through today. High $111.6, low $83.89. Run-up to date -14.6%. Decision 8/17/26. Historical price action, not a forecast.

Key facts

PDUFA date2026-08-17
Business days away26
Drug / candidateKEYTRUDA (pembrolizumab) + Padcev
IndicationPerioperative muscle-invasive bladder cancer (sBLA)
CompanyMerck
Market-cap tier
Cohort decision-day move (history)±2% median

Cohort move is the historical median absolute decision-day move for this market-cap tier — history, not a prediction. See the full 2026 PDUFA calendar →