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URGN FDA Decision CRL · 2025-04-27

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)

$11.64$9.29
Historical price action; green = local high, red = low/sell-off.

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.
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