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TEVA FDA Decision Approved · 2025-10-10

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 10/10/25$20.21$13.314/25/25
Daily close, T-120 (4/25/25) through T+5. Run-up high $20.21 on 10/8/25, low $13.31 on 4/25/25 (T-120 to T-1). FDA decision 10/10/25. Historical price action, not a forecast.
Positioning before the decision
On Sep 26, 2025, 14 days before the decision date, at-the-money options priced a move of ±7.5% through Oct 17, 2025 (the first listed expiry after the decision; ATM implied volatility 39%). The stock closed -0.0% at the first close across the decision and -2.0% 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 date2025-10-10
DrugUZEDY(R) (risperidone) Extended-Release Injectable Suspension
IndicationBipolar I Disorder
Outcome✓ Approvedprimary-sourced
Decision-day move+-0.0%
T-120 run-up (low→high)+12.0% ($15.38→$20.21)
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 UZEDY(R) (risperidone) Extended-Release Injectable Suspension approved by the FDA?

Yes. The FDA approved the application for UZEDY(R) (risperidone) Extended-Release Injectable Suspension on October 10, 2025. The primary source is linked on this page.

What was UZEDY(R) (risperidone) Extended-Release Injectable Suspension under FDA review for?

The application covered Bipolar I Disorder. The FDA approved the application on October 10, 2025.

How did TEVA stock react to the FDA decision?

On the decision day TEVA moved +-0.0%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.