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AZN FDA Decision Approved · 2025-01-27

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 1/27/25$175.24$126.48/12/24
Daily close, T-120 (8/12/24) through T+5. Run-up high $175.24 on 9/9/24, low $126.4 on 11/27/24 (T-120 to T-1). FDA decision 1/27/25. Historical price action, not a forecast.
Positioning before the decision
On Jan 13, 2025, 14 days before the decision date, at-the-money options priced a move of ±4.1% through Jan 31, 2025 (the first listed expiry after the decision; ATM implied volatility 23%). The stock closed +1.5% at the first close across the decision and +2.5% 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 date2025-01-27
DrugEnhertu - (DESTINY-Breast06)
IndicationHR-positive, HER2-low (IHC 1+ or 2+/ISH-) metastatic breast cancer
Outcome✓ Approvedprimary-sourced
Decision-day move+0.7%
T-120 run-up (low→high)+4.0% ($124.7→$158.94)
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.

See the full 2026 PDUFA calendar →

Questions

Was Enhertu - (DESTINY-Breast06) approved by the FDA?

Yes. The FDA approved the application for Enhertu - (DESTINY-Breast06) on January 27, 2025. The primary source is linked on this page.

What was Enhertu - (DESTINY-Breast06) under FDA review for?

The application covered HR-positive, HER2-low (IHC 1+ or 2+/ISH-) metastatic breast cancer. The FDA approved the application on January 27, 2025.

How did AZN stock react to the FDA decision?

On the decision day AZN moved +0.7%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.