Page updated ·next FDA decision on the calendar·Data as of Oct 14, 2026 7:39 PM ET
Price into the decision (T-120)
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)
Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.
Questions
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 12, 2025, per the FDA's own record. The company announced it 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.