Daily close, T-120 (3/25/25) through T+5. Run-up high $179.29 on 8/25/25, low $146.36 on 5/20/25 (T-120 to T-1). FDA decision 9/9/25. Historical price action, not a forecast.
Positioning before the decision
On Aug 26, 2025, 14 days before the decision date, at-the-money options priced a move of ±2.5% through Sep 12, 2025 (the first listed expiry after the decision; ATM implied volatility 14%). The stock closed -0.7% at the first close across the decision and -0.4% 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.
Was INLEXZO (gemcitabine intravesical system) (TAR-200) - (SunRISe-1) approved by the FDA?
Yes. The FDA approved the application for INLEXZO (gemcitabine intravesical system) (TAR-200) - (SunRISe-1) on September 9, 2025. The primary source is linked on this page.
What was INLEXZO (gemcitabine intravesical system) (TAR-200) - (SunRISe-1) under FDA review for?
The application covered Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer. The FDA approved the application on September 9, 2025.
How did JNJ stock react to the FDA decision?
On the decision day JNJ moved -0.7%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.