UGN-103 PDUFA date: FDA decision expected June 14, 2027
The FDA is expected to decide on UGN-103 from UroGen Pharma Ltd. in recurrent low-grade intermediate-risk non–muscle invasive bladder cancer by the PDUFA target action date of June 14, 2027. For recurrent low-grade intermediate-risk non–muscle invasive bladder cancer. nda filing. AI-extracted from news: <![CDATA[FDA Accepts NDA for UGN-103 in Recurrent Low-Grade Intermediate-Risk NMIBC]]>
A PDUFA date is the FDA's target deadline to complete its review of a drug application — approval, a complete response letter (CRL), or an extension are all possible. What is a PDUFA date? This page is research information, not financial advice.
Source: cancernetwork.com · Data checked October 20, 2026. How we check dates. Confirm dates against the company's or the FDA's announcement before acting.
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Questions about this FDA decision
- When is the PDUFA date for UGN-103?
- The FDA's PDUFA target action date for UGN-103 is June 14, 2027. The FDA can act before that date, and the review can be extended.
- What is UGN-103 being reviewed for?
- The application under FDA review covers recurrent low-grade intermediate-risk non–muscle invasive bladder cancer.
- Which company is developing UGN-103?
- UroGen Pharma Ltd. (URGN).
- What can happen on a PDUFA date?
- The FDA approves the application, issues a complete response letter (CRL) listing what must be fixed before approval, or extends the review (typically by three months after a major amendment).