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ABBV FDA Decision Approved · 2025-02-07

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 2/7/25$203.87$164.998/23/24
Daily close, T-120 (8/23/24) through T+5. Run-up high $203.87 on 11/7/24, low $164.99 on 11/22/24 (T-120 to T-1). FDA decision 2/7/25. Historical price action, not a forecast.
Positioning before the decision
On Jan 24, 2025, 14 days before the decision date, at-the-money options priced a move of ±5.4% through Feb 14, 2025 (the first listed expiry after the decision; ATM implied volatility 28%). The stock closed -1.2% at the first close across the decision and +0.2% 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 date2025-02-07
DrugEMBLAVEO (aztreonam and avibactam)
IndicationComplicated Intra-abdominal Infection and Hosptial Acquired Pneumonia
Outcome✓ Approvedprimary-sourced
Decision-day move-1.2%
T-120 run-up (low→high)+5.0% ($164.99→$203.87)
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 EMBLAVEO (aztreonam and avibactam) approved by the FDA?

Yes. The FDA approved the application for EMBLAVEO (aztreonam and avibactam) on February 7, 2025. The primary source is linked on this page.

What was EMBLAVEO (aztreonam and avibactam) under FDA review for?

The application covered Complicated Intra-abdominal Infection and Hosptial Acquired Pneumonia. The FDA approved the application on February 7, 2025.

How did ABBV stock react to the FDA decision?

On the decision day ABBV moved -1.2%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.