Daily close, T-120 (12/26/24) through T+5. Run-up high $12.13 on 3/25/25, low $3.93 on 5/27/25 (T-120 to T-1). FDA decision 6/12/25. Historical price action, not a forecast.
Positioning before the decision
On May 29, 2025, 14 days before the decision date, at-the-money options priced a move of ±74.5% through Jun 20, 2025 (the first listed expiry after the decision; ATM implied volatility 394%). The stock closed +51.8% at the first close across the decision and +103.7% 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 ZUSDURI (VesiGel UGN-102 (mitomycin)) - (ENVISION) approved by the FDA?
Yes. The FDA approved the application for ZUSDURI (VesiGel UGN-102 (mitomycin)) - (ENVISION) on June 12, 2025. The primary source is linked on this page.
What was ZUSDURI (VesiGel UGN-102 (mitomycin)) - (ENVISION) under FDA review for?
The application covered Low grade non-muscle invasive bladder cancer (LG-NMIBC). The FDA approved the application on June 12, 2025.
How did URGN stock react to the FDA decision?
On the decision day URGN moved +51.8%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.