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AMGN FDA Decision Approved · 2025-04-03

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 4/3/25$328.35$258.5910/17/24
Daily close, T-120 (10/17/24) through T+5. Run-up high $328.35 on 10/21/24, low $258.59 on 1/9/25 (T-120 to T-1). FDA decision 4/3/25. Historical price action, not a forecast.
Positioning before the decision
On Mar 20, 2025, 14 days before the decision date, at-the-money options priced a move of ±3.5% through Apr 4, 2025 (the first listed expiry after the decision; ATM implied volatility 22%). The stock closed +1.4% at the first close across the decision and -4.8% 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 date2025-04-03
DrugUPLIZNA (INEBILIZUMAB-CDON)
IndicationImmunoglobulin G4-related disease (IgG4-RD)
Outcome✓ Approvedprimary-sourced
Decision-day move+1.4%
T-120 run-up (low→high)+18.0% ($258.59→$327.36)
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 UPLIZNA (INEBILIZUMAB-CDON) approved by the FDA?

Yes. The FDA approved the application for UPLIZNA (INEBILIZUMAB-CDON) on April 3, 2025. The primary source is linked on this page.

What was UPLIZNA (INEBILIZUMAB-CDON) under FDA review for?

The application covered Immunoglobulin G4-related disease (IgG4-RD). The FDA approved the application on April 3, 2025.

How did AMGN stock react to the FDA decision?

On the decision day AMGN moved +1.4%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.