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 (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.
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
Questions
Was ZUSDURI (VesiGel UGN-102 (mitomycin)) approved by the FDA?
Yes. The FDA approved the application for ZUSDURI (VesiGel UGN-102 (mitomycin)) on June 12, 2025, per the FDA's own record. The primary source is linked on this page.
What was ZUSDURI (VesiGel UGN-102 (mitomycin)) 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.