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NVAX FDA Decision Approved · 2025-08-27

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Price into the decision (T-120)

PDUFA 8/27/25$9.71$5.433/12/25
Daily close, T-120 (3/12/25) through T+5. Run-up high $9.71 on 8/18/25, low $5.43 on 4/16/25 (T-120 to T-1). FDA decision 8/27/25. Historical price action, not a forecast.
Positioning before the decision
On Aug 13, 2025, 14 days before the decision date, at-the-money options priced a move of ±12.2% through Aug 29, 2025 (the first listed expiry after the decision; ATM implied volatility 73%). The stock closed +1.1% at the first close across the decision and -1.3% 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 date2025-08-27
DrugNuvaxovid - (2025-2026 Formula)
IndicationCOVID-19 Vaccine
Outcome✓ Approvedprimary-sourced
Decision-day move+1.1%
T-120 run-up (low→high)+46.0% ($5.95→$9.71)
Market-cap tierMicro
Cohort decision-day move (history)4.6% median (n=308)

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 Nuvaxovid - (2025-2026 Formula) approved by the FDA?

Yes. The FDA approved the application for Nuvaxovid - (2025-2026 Formula) on August 27, 2025. The primary source is linked on this page.

What was Nuvaxovid - (2025-2026 Formula) under FDA review for?

The application covered COVID-19 Vaccine. The FDA approved the application on August 27, 2025.

How did NVAX stock react to the FDA decision?

On the decision day NVAX moved +1.1%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.