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NVO FDA Decision Approved · 2025-12-22

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 12/22/25$71.7$44.977/7/25
Daily close, T-120 (7/7/25) through T+5. Run-up high $71.7 on 7/29/25, low $44.97 on 11/25/25 (T-120 to T-1). FDA decision 12/22/25. Historical price action, not a forecast.
Positioning before the decision
On Dec 8, 2025, 14 days before the decision date, at-the-money options priced a move of ±6.4% through Dec 26, 2025 (the first listed expiry after the decision; ATM implied volatility 36%). The stock closed +0.0% at the first close across the decision and +7.0% 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 date2025-12-22
DrugWegovy pill (once-daily oral semaglutide 25 mg)
IndicationReduce excess body weight, maintain weight reduction long term, reduce the risk of major a
Outcome✓ Approvedprimary-sourced
Decision-day move+0.0%
T-120 run-up (low→high)+14.0% ($44.97→$61.85)
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 pill (once-daily oral semaglutide 25 mg) approved by the FDA?

Yes. The FDA approved the application for Wegovy pill (once-daily oral semaglutide 25 mg) on December 22, 2025. The primary source is linked on this page.

What was Wegovy pill (once-daily oral semaglutide 25 mg) under FDA review for?

The application covered Reduce excess body weight, maintain weight reduction long term, reduce the risk of major a. The FDA approved the application on December 22, 2025.

How did NVO stock react to the FDA decision?

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