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JNJ FDA Decision Approved · 2025-04-30

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 4/30/25$167.7$142.0611/13/24
Daily close, T-120 (11/13/24) through T+5. Run-up high $167.7 on 3/11/25, low $142.06 on 1/15/25 (T-120 to T-1). FDA decision 4/30/25. Historical price action, not a forecast.
Positioning before the decision
On Apr 16, 2025, 14 days before the decision date, at-the-money options priced a move of ±3.9% through May 2, 2025 (the first listed expiry after the decision; ATM implied volatility 23%). The stock closed +0.3% at the first close across the decision and -0.9% 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 date2025-04-30
DrugIMAAVY (Nipocalimab) - (Vivacity-MG3)
IndicationGeneralized myasthenia gravis (gMG)
Outcome✓ Approvedprimary-sourced
Decision-day move+0.3%
T-120 run-up (low→high)+16.0% ($142.06→$167.7)
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 IMAAVY (Nipocalimab) - (Vivacity-MG3) approved by the FDA?

Yes. The FDA approved the application for IMAAVY (Nipocalimab) - (Vivacity-MG3) on April 30, 2025. The primary source is linked on this page.

What was IMAAVY (Nipocalimab) - (Vivacity-MG3) under FDA review for?

The application covered Generalized myasthenia gravis (gMG). The FDA approved the application on April 30, 2025.

How did JNJ stock react to the FDA decision?

On the decision day JNJ moved +0.3%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.