pdufa.bio
HomeFDA Decisions › JNJ 2025-12-18

JNJ FDA Decision Approved · 2025-12-18

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 12/18/25$214.17$152.757/3/25
Daily close, T-120 (7/3/25) through T+5. Run-up high $214.17 on 12/15/25, low $152.75 on 7/3/25 (T-120 to T-1). FDA decision 12/18/25. Historical price action, not a forecast.
Positioning before the decision
On Dec 4, 2025, 14 days before the decision date, at-the-money options priced a move of ±2.9% through Dec 19, 2025 (the first listed expiry after the decision; ATM implied volatility 18%). The stock closed -1.0% at the first close across the decision and -1.2% 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 date2025-12-18
DrugRYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj)
IndicationAdvanced EGFR-mutated Non-Small Cell Lung Cancer
Outcome✓ Approvedprimary-sourced
Decision-day move-1.0%
T-120 run-up (low→high)+22.0% ($174.16→$214.17)
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.

See the full 2026 PDUFA calendar →

Questions

Was RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) approved by the FDA?

Yes. The FDA approved the application for RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) on December 18, 2025. The primary source is linked on this page.

What was RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) under FDA review for?

The application covered Advanced EGFR-mutated Non-Small Cell Lung Cancer. The FDA approved the application on December 18, 2025.

How did JNJ stock react to the FDA decision?

On the decision day JNJ moved -1.0%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.