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AMRX FDA Decision Approved · 2025-12-22

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 12/22/25$12.64$7.827/7/25
Daily close, T-120 (7/7/25) through T+5. Run-up high $12.64 on 12/18/25, low $7.82 on 8/4/25 (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 ±25.6% through Jan 16, 2026 (the first listed expiry after the decision; ATM implied volatility 194%). The stock closed +2.0% at the first close across the decision and +2.7% 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
DrugOziltus (denosumab-mobz)
IndicationOsteoporosis-related conditions
Outcome✓ Approvedprimary-sourced
Decision-day move+2.0%
T-120 run-up (low→high)+37.0% ($9.28→$12.87)
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.

See the full 2026 PDUFA calendar →

Questions

Was Oziltus (denosumab-mobz) approved by the FDA?

Yes. The FDA approved the application for Oziltus (denosumab-mobz) on December 22, 2025. The primary source is linked on this page.

What was Oziltus (denosumab-mobz) under FDA review for?

The application covered Osteoporosis-related conditions. The FDA approved the application on December 22, 2025.

How did AMRX stock react to the FDA decision?

On the decision day AMRX moved +2.0%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.