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AMGN FDA Decision Approved · 2025-01-17

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 1/17/25$337.38$258.598/2/24
Daily close, T-120 (8/2/24) through T+5. Run-up high $337.38 on 9/26/24, low $258.59 on 1/7/25 (T-120 to T-1). FDA decision 1/17/25. Historical price action, not a forecast.
Positioning before the decision
On Jan 3, 2025, 14 days before the decision date, at-the-money options priced a move of ±3.9% through Jan 24, 2025 (the first listed expiry after the decision; ATM implied volatility 20%). The stock closed +1.0% at the first close across the decision and +2.2% 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 date2025-01-17
DrugLUMAKRAS (Sotorasib) + Vectibix (panitumumab) - (CodeBreaK 300)
IndicationKRAS G12C-mutated solid tumors, CRC
Outcome✓ Approvedprimary-sourced
Decision-day move+1.0%
T-120 run-up (low→high)+1.0% ($258.59→$337.38)
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 LUMAKRAS (Sotorasib) + Vectibix (panitumumab) - (CodeBreaK 300) approved by the FDA?

Yes. The FDA approved the application for LUMAKRAS (Sotorasib) + Vectibix (panitumumab) - (CodeBreaK 300) on January 17, 2025. The primary source is linked on this page.

What was LUMAKRAS (Sotorasib) + Vectibix (panitumumab) - (CodeBreaK 300) under FDA review for?

The application covered KRAS G12C-mutated solid tumors, CRC. The FDA approved the application on January 17, 2025.

How did AMGN stock react to the FDA decision?

On the decision day AMGN moved +1.0%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.