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JNJ FDA Decision Approved · 2025-11-06

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 11/6/25$193.72$149.795/22/25
Daily close, T-120 (5/22/25) through T+5. Run-up high $193.72 on 10/20/25, low $149.79 on 6/24/25 (T-120 to T-1). FDA decision 11/6/25. Historical price action, not a forecast.
Positioning before the decision
On Oct 23, 2025, 14 days before the decision date, at-the-money options priced a move of ±2.6% through Nov 7, 2025 (the first listed expiry after the decision; ATM implied volatility 16%). The stock closed +0.5% at the first close across the decision and +4.5% 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 date2025-11-06
DrugCAPLYTA (lumateperone) - (Study 502)
IndicationMajor depressive disorder (MDD)
Outcome✓ Approvedprimary-sourced
Decision-day move+0.5%
T-120 run-up (low→high)+25.0% ($155.17→$193.72)
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 CAPLYTA (lumateperone) - (Study 502) approved by the FDA?

Yes. The FDA approved the application for CAPLYTA (lumateperone) - (Study 502) on November 6, 2025. The primary source is linked on this page.

What was CAPLYTA (lumateperone) - (Study 502) under FDA review for?

The application covered Major depressive disorder (MDD). The FDA approved the application on November 6, 2025.

How did JNJ stock react to the FDA decision?

On the decision day JNJ moved +0.5%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.