Daily close, T-120 (6/30/25) through T+5. Run-up high $211.58 on 12/12/25, low $152.01 on 7/1/25 (T-120 to T-1). FDA decision 12/15/25. Historical price action, not a forecast.
Positioning before the decision
On Dec 1, 2025, 14 days before the decision date, at-the-money options priced a move of ±3.3% through Dec 19, 2025 (the first listed expiry after the decision; ATM implied volatility 18%). The stock closed +1.2% at the first close across the decision and -2.5% 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 date2025-12-15
DrugAKEEGA (niraparib and abiraterone acetate dual-action tablet) plus prednisone
IndicationBRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC)
Was AKEEGA (niraparib and abiraterone acetate dual-action tablet) plus pre approved by the FDA?
Yes. The FDA approved the application for AKEEGA (niraparib and abiraterone acetate dual-action tablet) plus pre on December 15, 2025. The primary source is linked on this page.
What was AKEEGA (niraparib and abiraterone acetate dual-action tablet) plus pre under FDA review for?
The application covered BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC). The FDA approved the application on December 15, 2025.
How did JNJ stock react to the FDA decision?
On the decision day JNJ moved +1.2%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.