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AZN FDA Decision Approved · 2025-06-23

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 6/23/25$155.92$129.741/6/25
Daily close, T-120 (1/6/25) through T+5. Run-up high $155.92 on 3/10/25, low $129.74 on 4/15/25 (T-120 to T-1). FDA decision 6/23/25. Historical price action, not a forecast.
Positioning before the decision
On Jun 9, 2025, 14 days before the decision date, at-the-money options priced a move of ±4.0% through Jun 27, 2025 (the first listed expiry after the decision; ATM implied volatility 23%). The stock closed +1.0% at the first close across the decision and -0.1% 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 date2025-06-23
DrugDATROWAY (datopotamab deruxtecan-dlnk)- (TROPION-Lung01)
IndicationNon-small cell lung cancer (NSCLC)
Outcome✓ Approvedprimary-sourced
Decision-day move+1.7%
T-120 run-up (low→high)+9.0% ($128.91→$157.58)
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 DATROWAY (datopotamab deruxtecan-dlnk)- (TROPION-Lung01) approved by the FDA?

Yes. The FDA approved the application for DATROWAY (datopotamab deruxtecan-dlnk)- (TROPION-Lung01) on June 23, 2025. The primary source is linked on this page.

What was DATROWAY (datopotamab deruxtecan-dlnk)- (TROPION-Lung01) under FDA review for?

The application covered Non-small cell lung cancer (NSCLC). The FDA approved the application on June 23, 2025.

How did AZN stock react to the FDA decision?

On the decision day AZN moved +1.7%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.