Daily close, T-120 (6/30/25) through T+5. Run-up high $186.64 on 11/27/25, low $137.44 on 7/23/25 (T-120 to T-1). FDA decision 12/15/25. Historical price action, not a forecast.
Positioning before the decision
On Dec 1, 2025, 14 days before the decision date, at-the-money options priced a move of ±4.1% through Dec 19, 2025 (the first listed expiry after the decision; ATM implied volatility 22%). The stock closed +1.9% 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 date2025-12-15
DrugEnhertu (trastuzumab deruxtecan) with pertuzumab - (DESTINY-Breast09)
Was Enhertu (trastuzumab deruxtecan) with pertuzumab - (DESTINY-Breast09) approved by the FDA?
Yes. The FDA approved the application for Enhertu (trastuzumab deruxtecan) with pertuzumab - (DESTINY-Breast09) on December 15, 2025. The primary source is linked on this page.
What was Enhertu (trastuzumab deruxtecan) with pertuzumab - (DESTINY-Breast09) under FDA review for?
The application covered Early HER2+ Metastatic Breast Cancer. The FDA approved the application on December 15, 2025.
How did AZN stock react to the FDA decision?
On the decision day AZN moved +2.3%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.