URGN FDA decision dates

Page updated November 5, 2026·next FDA decision on the calendar ·Data as of Nov 5, 2026 5:03 AM ET

URGN has 1 upcoming FDA decision date; the nearest is Jun 14, 2027 for UGN-103 (mitomycin) - low-grade intermediate-risk NMIBC. 2 past decisions are on record below, each on its own page. One event, one page: past decisions never share a URL with a live catalyst.

URGN catalyst hub · full calendar

Upcoming

Jun 14, 2027 in 221 daysUGN-103 (mitomycin) - low-grade intermediate-risk NMIBC

Decided

Jun 12, 2025 ✓ ApprovedZUSDURI Apr 27, 2025 CRLprice-only

Facts and dates only; not investment advice. Verify against primary FDA, SEC and company filings. pdufa.bio is not affiliated with the FDA.

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