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AMRX FDA Decision Approved · 2025-05-15

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 5/15/25$9.01$6.9711/28/24
Daily close, T-120 (11/28/24) through T+5. Run-up high $9.01 on 3/21/25, low $6.97 on 4/11/25 (T-120 to T-1). FDA decision 5/15/25. Historical price action, not a forecast.
Positioning before the decision
On May 1, 2025, 14 days before the decision date, at-the-money options priced a move of ±16.0% through May 16, 2025 (the first listed expiry after the decision; ATM implied volatility 100%). The stock closed +2.0% at the first close across the decision and -1.1% 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 date2025-05-15
DrugBrekiya (dihydroergotamine mesylate) injection
IndicationMigraine with or without aura and cluster headache in adults
Outcome✓ Approvedprimary-sourced
Decision-day move+2.0%
T-120 run-up (low→high)+17.0% ($6.97→$9.01)
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 Brekiya (dihydroergotamine mesylate) injection approved by the FDA?

Yes. The FDA approved the application for Brekiya (dihydroergotamine mesylate) injection on May 15, 2025. The primary source is linked on this page.

What was Brekiya (dihydroergotamine mesylate) injection under FDA review for?

The application covered Migraine with or without aura and cluster headache in adults. The FDA approved the application on May 15, 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.