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JNJ FDA Decision Approved · 2025-09-29

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 9/29/25$179.71$146.364/14/25
Daily close, T-120 (4/14/25) through T+5. Run-up high $179.71 on 9/26/25, low $146.36 on 5/20/25 (T-120 to T-1). FDA decision 9/29/25. Historical price action, not a forecast.
Positioning before the decision
On Sep 15, 2025, 14 days before the decision date, at-the-money options priced a move of ±2.8% through Oct 3, 2025 (the first listed expiry after the decision; ATM implied volatility 16%). The stock closed +1.1% at the first close across the decision and +5.0% 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 date2025-09-29
DrugTREMFYA (guselkumab)
IndicationSevere plaque psoriasis (PsO)
Outcome✓ Approvedprimary-sourced
Decision-day move+1.1%
T-120 run-up (low→high)+22.0% ($149.79→$186.05)
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 TREMFYA (guselkumab) approved by the FDA?

Yes. The FDA approved the application for TREMFYA (guselkumab) on September 29, 2025. The primary source is linked on this page.

What was TREMFYA (guselkumab) under FDA review for?

The application covered Severe plaque psoriasis (PsO). The FDA approved the application on September 29, 2025.

How did JNJ stock react to the FDA decision?

On the decision day JNJ moved +1.1%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.