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)4.6% median (n=308)
Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.