Daily close, T-120 (8/12/25) through T+5. Run-up high $221.49 on 1/26/26, low $170.59 on 8/13/25 (T-120 to T-1). FDA decision 1/27/26. 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 date2026-01-27
DrugDARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenal
Was DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in combination wi approved by the FDA?
Yes. The FDA approved the application for DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in combination wi on January 27, 2026. The primary source is linked on this page.
What was DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in combination wi under FDA review for?
The application covered Newly diagnosed multiple myeloma (NDMM). The FDA approved the application on January 27, 2026.
How did JNJ stock react to the FDA decision?
On the decision day JNJ moved +1.3%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.