URGN PDUFA Date: UGN-103 Page updated November 5, 2026 · next FDA decision on the calendar · Data as of Nov 5, 2026 5:03 AM ET FDA decision (PDUFA) target Jun 14, 2027 · UroGen Pharma Ltd. · Low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC)
Key facts FDA PDUFA target date 2027-06-14
Drug / candidate UGN-103 (mitomycin)
Indication Low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC)
Company UroGen Pharma Ltd.
Market-cap tier Small
New to FDA decisions? Read what a PDUFA date is and how often the FDA approves drugs .
See every 2027 PDUFA date → All June 2027 PDUFA dates → FAQ When is the URGN PDUFA date? The FDA PDUFA target date for URGN (UroGen Pharma Ltd.) is 2027-06-14 for UGN-103 (mitomycin). Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is URGN's drug UGN-103? UGN-103 (mitomycin) is UroGen Pharma Ltd.'s candidate under FDA review for Low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
Not affiliated with or endorsed by the FDA. pdufa.bio is an independent publication with no affiliation with, endorsement by, sponsorship by, or connection to the U.S. Food and Drug Administration or any other government agency. “FDA”, “PDUFA” and all company, drug and ticker names are used descriptively and remain the property of their respective owners.Informational and educational purposes only. Not investment advice. Nothing on this page is investment, legal, tax or medical advice, or an offer or solicitation to buy or sell any security. pdufa.bio is not a registered investment adviser or broker-dealer and does not recommend trades or publish individual-drug approval probabilities. Verify every date and outcome against primary FDA, SEC or company filings. Data is provided as is, without warranty of any kind, and past behaviour does not predict future outcomes.