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Home › FDA Decisions › MRK 2026-02-20

MRK FDA Decision Approved · 2026-02-20

Page updated ·next FDA decision on the calendar ·Data as of Nov 5, 2026 9:00 PM ET

Price into the decision (T-120)

PDUFA 2/20/26$121.93$77.69/5/25
Daily close, T-120 (9/5/25) through T+5. Run-up high $121.93 on 2/9/26, low $77.6 on 10/2/25 (T-120 to T-1). FDA decision 2/20/26. Historical price action, not a forecast.

Decision facts

FDA decision date2026-02-20
DrugKEYTRUDA + chemo ± bevacizumab (ovarian)
IndicationPlatinum-resistant ovarian cancer
Outcome✓ Approvedprimary-sourced
Decision-day move+0.3%
T-120 run-up (low→high)+43.0% ($82.49→$123.82)
ValidationVerified 2026-08-12: Drugs@FDA, application BLA125514, action date 2026-02-10
Market-cap tierLarge
Cohort decision-day move (history)1.0% median (n=895)

Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.

See the full 2026 PDUFA calendar →

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

FundSharesValue at quarter endFiling
OrbiMed Advisors663,400$85.2 millionfiled 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.

Questions

Was KEYTRUDA + chemo ± bevacizumab (ovarian) approved by the FDA?

Yes. The FDA approved the application for KEYTRUDA + chemo ± bevacizumab (ovarian) on February 10, 2026, per the FDA's own record. The company announced it on February 20, 2026. The primary source is linked on this page.

What was KEYTRUDA + chemo ± bevacizumab (ovarian) under FDA review for?

The application covered Platinum-resistant ovarian cancer. The FDA approved the application on February 20, 2026.

How did MRK stock react to the FDA decision?

On the decision day MRK moved +0.3%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.