Rebuilt daily·next FDA decision on the calendar·Data as of Nov 5, 2026 9:00 PM ET
ZUSDURI (UGN-102) was FDA-APPROVED June 12, 2025; the April 2025 date was not a CRL: archive 'CRL' label appears erroneous.
Price into the decision (T-120)
Daily close, T-120 (11/8/24) through T+5. Run-up high $13.02 on 11/8/24, low $9.27 on 3/4/25 (T-120 to T-1). FDA decision 4/27/25. Historical price action, not a forecast.
Decision facts
FDA decision date2025-04-27
Outcome✗ CRL⚠ label corrected
Decision-day move+14.1%
T-120 run-up (low→high)+12.0% ($9.27→$12.13)
CRL reasonZUSDURI (UGN-102) was FDA-APPROVED June 12, 2025; the April 2025 date was not a CRL: archive 'CRL' label appears erroneous.
ValidationOutcome consistent with price; primary-source verification in progress.
Market-cap tierMicro
Cohort decision-day move (history)4.7% median (n=312)
Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.
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.