KEYTRUDA (pembrolizumab) and KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph), each with Padcev (enfortumab vedotin-ejfv), approved as treatment before and after surgery for muscle-invasive bladder cancer (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 $129.56 on 7/2/26, low $106.9 on 1/28/26 (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)
CompanyMerck & Company Inc.
Market-cap tierLarge
120-day run-up (T-120→T-1)+12.7%
Cohort decision-day move (history)1.0% median (n=828)
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), a date Merck disclosed in its Q1 2026 Form 8-K. The FDA approved on July 10, 2026, about five weeks early, and did so regardless of cisplatin eligibility.
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.
Was KEYTRUDA (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) - (KEYN approved by the FDA?
Yes. The FDA approved the application for KEYTRUDA (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) - (KEYN on July 10, 2026. The primary source is linked on this page.
Which company is behind KEYTRUDA (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) - (KEYN?
KEYTRUDA (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) - (KEYN is a Merck & Company Inc. (MRK) program. The FDA decision came on July 10, 2026; the company's own announcement is linked on this page.
How did MRK stock trade into the FDA decision?
Measured over the 120 trading days before the decision (T-120 to T-1), MRK moved +12.7%. That is the recorded price path into this specific event -- historical measurement, not a prediction, and not investment advice.
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