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JAZZ FDA Decision Approved · 2025-10-02

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 10/2/25$136.9$97.784/17/25
Daily close, T-120 (4/17/25) through T+5. Run-up high $136.9 on 10/1/25, low $97.78 on 5/15/25 (T-120 to T-1). FDA decision 10/2/25. Historical price action, not a forecast.
Positioning before the decision
On Sep 18, 2025, 14 days before the decision date, at-the-money options priced a move of ±7.9% through Oct 17, 2025 (the first listed expiry after the decision; ATM implied volatility 35%). The stock closed +0.2% at the first close across the decision and +0.6% 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 date2025-10-02
DrugZepzelca (lurbinectedin) and Atezolizumab (Tecentriq)
IndicationFirst-line, Small Cell Lung Cancer (SCLC)
Outcome✓ Approvedprimary-sourced
Decision-day move+0.2%
T-120 run-up (low→high)+29.0% ($105.93→$139.48)
Market-cap tierMid
Cohort decision-day move (history)2.1% median (n=234)

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 Zepzelca (lurbinectedin) and Atezolizumab (Tecentriq) approved by the FDA?

Yes. The FDA approved the application for Zepzelca (lurbinectedin) and Atezolizumab (Tecentriq) on October 2, 2025. The primary source is linked on this page.

What was Zepzelca (lurbinectedin) and Atezolizumab (Tecentriq) under FDA review for?

The application covered First-line, Small Cell Lung Cancer (SCLC). The FDA approved the application on October 2, 2025.

How did JAZZ stock react to the FDA decision?

On the decision day JAZZ moved +0.2%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.