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Home › FDA Decisions › AZN 2025-01-27

AZN FDA Decision Approved · 2025-01-27

Page updated ·next FDA decision on the calendar ·Data as of Oct 14, 2026 7:39 PM ET

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)
ValidationVerified 2026-08-12: Drugs@FDA, application BLA761139, action date 2025-01-27
Market-cap tierLarge
Cohort decision-day move (history)1.0% median (n=837)

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 →

Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.

Specialist biotech funds holding AZN, 13F for the quarter ended June 30, 2026

FundSharesValue at quarter endFiling
OrbiMed Advisors915,700$171.1 millionfiled August 14, 2026

13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.

Questions

Was Enhertu approved by the FDA?

Yes. The FDA approved the application for Enhertu on January 27, 2025, per the FDA's own record. The primary source is linked on this page.

What was Enhertu 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.