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Home › FDA Decisions › MRK 2025-05-14

MRK FDA Decision Approved · 2025-05-14

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 5/14/25$103.79$75.9711/27/24
Daily close, T-120 (11/27/24) through T+5. Run-up high $103.79 on 12/17/24, low $75.97 on 5/9/25 (T-120 to T-1). FDA decision 5/14/25. Historical price action, not a forecast.
Positioning before the decision
On Apr 30, 2025, 14 days before the decision date, at-the-money options priced a move of ±5.5% through May 16, 2025 (the first listed expiry after the decision; ATM implied volatility 33%). The stock closed -4.1% at the first close across the decision and +1.7% five trading days on. A straddle priced weeks out covers ordinary movement plus the event, so this is the move the options market priced through that expiry, not the event-implied move alone. How this compares across 1,000+ decisions.

Decision facts

FDA decision date2025-05-14
DrugWELIREG (belzutifan)
IndicationAdvanced Pheochromocytoma and Paraganglioma (PPGL)
Outcome✓ Approvedprimary-sourced
Decision-day move-4.1%
T-120 run-up (low→high)+2.0% ($73.47→$100.98)
ValidationVerified 2026-08-12: Drugs@FDA, application NDA215383, action date 2025-05-14
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 WELIREG (belzutifan) approved by the FDA?

Yes. The FDA approved the application for WELIREG (belzutifan) on May 14, 2025, per the FDA's own record. The primary source is linked on this page.

What was WELIREG (belzutifan) under FDA review for?

The application covered Advanced Pheochromocytoma and Paraganglioma (PPGL). The FDA approved the application on May 14, 2025.

How did MRK stock react to the FDA decision?

On the decision day MRK moved -4.1%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.