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SNY FDA Decision Approved · 2025-03-28

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 3/28/25$59.42$45.8910/11/24
Daily close, T-120 (10/11/24) through T+5. Run-up high $59.42 on 3/6/25, low $45.89 on 12/23/24 (T-120 to T-1). FDA decision 3/28/25. Historical price action, not a forecast.
Positioning before the decision
On Mar 14, 2025, 14 days before the decision date, at-the-money options priced a move of ±5.2% through Apr 17, 2025 (the first listed expiry after the decision; ATM implied volatility 21%). The stock closed +1.7% at the first close across the decision and -0.5% 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 date2025-03-28
DrugQfitlia (fitusiran) - (ATLAS)
IndicationHemophilia A/B
Outcome✓ Approvedprimary-sourced
Decision-day move+1.7%
T-120 run-up (low→high)+23.0% ($45.89→$59.42)
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 Qfitlia (fitusiran) - (ATLAS) approved by the FDA?

Yes. The FDA approved the application for Qfitlia (fitusiran) - (ATLAS) on March 28, 2025. The primary source is linked on this page.

What was Qfitlia (fitusiran) - (ATLAS) under FDA review for?

The application covered Hemophilia A/B. The FDA approved the application on March 28, 2025.

How did SNY stock react to the FDA decision?

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