Page updated ·next FDA decision on the calendar·Data as of Oct 11, 2026 9:31 PM ET
✓ APPROVED
KEYTRUDA and KEYTRUDA QLEX was approved by the FDA for Platinum-Resistant Recurrent Ovarian Cancer; the approval was announced on February 11, 2026.
Merck & Company Inc., KEYTRUDA and KEYTRUDA QLEX · Platinum-Resistant Recurrent Ovarian Cancer.
Run-up into the decision (T-120 → T+5)
Daily close, T-120 (8/27/25) through T+5. Run-up high $121.93 on 2/6/26, low $77.6 on 10/1/25 (T-120 to T-1). FDA decision 2/11/26. Historical price action, not a forecast.
Key facts
FDA decision date2026-02-11
OutcomeApproved
Drug / candidateKEYTRUDA and KEYTRUDA QLEX
CompanyMerck & Company Inc.
120-day run-up (T-120→T-1)+38.4%
Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.
Specialist biotech funds holding MRK, 13F for the quarter ended June 30, 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.
Questions
Was KEYTRUDA and KEYTRUDA QLEX approved by the FDA?
Yes. The approval of the application for KEYTRUDA and KEYTRUDA QLEX was announced on February 11, 2026; pdufa.bio holds no FDA record stating the exact day the FDA acted. The primary source is linked on this page.
Which company is behind KEYTRUDA and KEYTRUDA QLEX?
KEYTRUDA and KEYTRUDA QLEX is a Merck & Company Inc. (MRK) program. The company announced the FDA decision on February 11, 2026; the primary source 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 +38.4%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.
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