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BMY FDA Decision Approved · 2025-04-08

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 4/8/25$63.11$51.9210/22/24
Daily close, T-120 (10/22/24) through T+5. Run-up high $63.11 on 3/10/25, low $51.92 on 11/4/24 (T-120 to T-1). FDA decision 4/8/25. Historical price action, not a forecast.
Positioning before the decision
On Mar 25, 2025, 14 days before the decision date, at-the-money options priced a move of ±5.1% through Apr 11, 2025 (the first listed expiry after the decision; ATM implied volatility 30%). The stock closed -3.8% at the first close across the decision and -7.0% 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 date2025-04-08
DrugOpdivo (nivolumab) plus Yervoy - (CheckMate -8HW)
IndicationMicrosatellite Instability-High or Mismatch Repair Deficient Metastatic Colorectal Cancer
Outcome✓ Approvedprimary-sourced
Decision-day move-3.8%
T-120 run-up (low→high)+7.0% ($50.46→$63.11)
Market-cap tierLarge
Cohort decision-day move (history)1.0% median (n=835)

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

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Questions

Was Opdivo (nivolumab) plus Yervoy - (CheckMate -8HW) approved by the FDA?

Yes. The FDA approved the application for Opdivo (nivolumab) plus Yervoy - (CheckMate -8HW) on April 8, 2025. The primary source is linked on this page.

What was Opdivo (nivolumab) plus Yervoy - (CheckMate -8HW) under FDA review for?

The application covered Microsatellite Instability-High or Mismatch Repair Deficient Metastatic Colorectal Cancer. The FDA approved the application on April 8, 2025.

How did BMY stock react to the FDA decision?

On the decision day BMY moved -3.8%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.