UroGen says Phase 3 UTOPIA trial shows 94.5% six-month response durability for UGN-103

  • UroGen Pharma reported interim Phase 3 UTOPIA trial data showing responses to UGN-103 remained durable at six months in recurrent low-grade intermediate-risk non-muscle invasive bladder cancer; results have been presented.
  • Outcome tracked closely with prior pivotal data for ZUSDURI, supporting management’s view that UGN-103 could sustain clinical benefit while offering a simplified product format for use in practice.
  • NDA submission for UGN-103 remains scheduled for Q3 2026, setting up a potential label-expansion style follow-on product strategy in this bladder cancer segment.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Urogen Pharma Ltd. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202605150800PRIMZONEFULLFEED9721035) on May 15, 2026, and is solely responsible for the information contained therein.

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