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NVO FDA Decision Approved · 2025-08-15

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 8/15/25$90.95$45.382/28/25
Daily close, T-120 (2/28/25) through T+5. Run-up high $90.95 on 3/3/25, low $45.38 on 8/6/25 (T-120 to T-1). FDA decision 8/15/25. Historical price action, not a forecast.
Positioning before the decision
On Aug 1, 2025, 14 days before the decision date, at-the-money options priced a move of ±9.4% through Aug 22, 2025 (the first listed expiry after the decision; ATM implied volatility 50%). The stock closed +2.9% at the first close across the decision and +10.1% 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 date2025-08-15
DrugWegovy (semaglutide) injection - (ESSENCE)
IndicationMetabolic dysfunction-associated steatohepatitis (MASH)
Outcome✓ Approvedprimary-sourced
Decision-day move+2.9%
T-120 run-up (low→high)+23.0% ($45.38→$81.05)
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 Wegovy (semaglutide) injection - (ESSENCE) approved by the FDA?

Yes. The FDA approved the application for Wegovy (semaglutide) injection - (ESSENCE) on August 15, 2025. The primary source is linked on this page.

What was Wegovy (semaglutide) injection - (ESSENCE) under FDA review for?

The application covered Metabolic dysfunction-associated steatohepatitis (MASH). The FDA approved the application on August 15, 2025.

How did NVO stock react to the FDA decision?

On the decision day NVO moved +2.9%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.