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BMY FDA Decision Approved · 2025-04-11

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 4/11/25$63.11$50.4610/25/24
Daily close, T-120 (10/25/24) through T+5. Run-up high $63.11 on 3/10/25, low $50.46 on 4/10/25 (T-120 to T-1). FDA decision 4/11/25. Historical price action, not a forecast.
Positioning before the decision
On Mar 28, 2025, 14 days before the decision date, at-the-money options priced a move of ±5.1% through Apr 17, 2025 (the first listed expiry after the decision; ATM implied volatility 27%). The stock closed +0.5% at the first close across the decision and -2.4% 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 date2025-04-11
DrugOpdivo (nivolumab) plus Yervoy (ipilimumab) - (CheckMate -9DW)
IndicationHepatocellular carcinoma (HCC)
Outcome✓ Approvedprimary-sourced
Decision-day move+0.5%
T-120 run-up (low→high)+7.0% ($50.46→$63.11)
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 BMY, 13F for the quarter ended June 30, 2026

FundSharesValue at quarter endFiling
OrbiMed Advisors925,000$53.3 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 Opdivo (nivolumab) plus Yervoy (ipilimumab) approved by the FDA?

Yes. The FDA approved the application for Opdivo (nivolumab) plus Yervoy (ipilimumab) on April 8, 2025, per the FDA's own record. The company announced it on April 11, 2025. The primary source is linked on this page.

What was Opdivo (nivolumab) plus Yervoy (ipilimumab) under FDA review for?

The application covered Hepatocellular carcinoma (HCC). The FDA approved the application on April 11, 2025.

How did BMY stock react to the FDA decision?

On the decision day BMY moved +0.5%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.