KEYTRUDA (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) was approved by the FDA for muscle-invasive bladder cancer (MIBC); the approval was announced on July 10, 2026.
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).
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.
Primary source: Merck press release, July 10, 2026
Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.
| Fund | Shares | Value at quarter end | Filing |
|---|---|---|---|
| OrbiMed Advisors | 663,400 | $85.2 million | filed August 14, 2026 |
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
Yes. The approval of the application for KEYTRUDA (pembrolizumab) was announced on July 10, 2026; pdufa.bio holds no FDA record stating the exact day the FDA acted. The primary source is linked on this page.
KEYTRUDA (pembrolizumab) is a Merck & Company Inc. (MRK) program. The company announced the FDA decision on July 10, 2026; the company's own announcement is linked on this page.
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.