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AZN FDA Decision Approved · 2025-11-25

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 11/25/25$183.04$137.446/10/25
Daily close, T-120 (6/10/25) through T+5. Run-up high $183.04 on 11/24/25, low $137.44 on 7/22/25 (T-120 to T-1). FDA decision 11/25/25. Historical price action, not a forecast.
Positioning before the decision
On Nov 11, 2025, 14 days before the decision date, at-the-money options priced a move of ±5.8% 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 -1.5% 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 date2025-11-25
DrugImfinzi (durvalumab) and FLOT Chemotherapy - (MATTERHORN)
IndicationResectable Gastric and Gastroesophageal Junction Cancer
Outcome✓ Approvedprimary-sourced
Decision-day move+2.7%
T-120 run-up (low→high)+28.0% ($141.77→$188.5)
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 Imfinzi (durvalumab) and FLOT Chemotherapy - (MATTERHORN) approved by the FDA?

Yes. The FDA approved the application for Imfinzi (durvalumab) and FLOT Chemotherapy - (MATTERHORN) on November 25, 2025. The primary source is linked on this page.

What was Imfinzi (durvalumab) and FLOT Chemotherapy - (MATTERHORN) under FDA review for?

The application covered Resectable Gastric and Gastroesophageal Junction Cancer. The FDA approved the application on November 25, 2025.

How did AZN stock react to the FDA decision?

On the decision day AZN moved +2.7%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.