UroGen Pharma Reports 77.8% Complete Response Rate in Phase 3 UTOPIA Trial for UGN-103

Reuters11-06

<a href="https://laohu8.com/S/URGN">UroGen</a> Pharma Reports 77.8% Complete Response Rate in Phase 3 UTOPIA Trial for UGN-103

UroGen Pharma Ltd. has announced preliminary results from its ongoing Phase 3 UTOPIA trial, evaluating UGN-103 (mitomycin) for intravesical solution in patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The trial demonstrated a 77.8% three-month complete response rate (95% CI, 68.3%, 85.5%). The company also reported that the U.S. Food and Drug Administration (FDA) has agreed that the complete response and durability results from the UTOPIA trial may support the submission of a New Drug Application (NDA) for UGN-103 for this indication. UGN-103 is designed to provide manufacturing and reconstitution improvements over the currently approved ZUSDURI (mitomycin) while maintaining prolonged drug exposure within the bladder. The NDA submission is planned for 2026. The results were announced publicly and are based on preliminary data from the ongoing study.

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: GNW9570022-en) on November 06, 2025, and is solely responsible for the information contained therein.

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The trial demonstrated a 77.8% three-month complete response rate (95% CI, 68.3%, 85.5%). The company also reported that the U.S. Food and Drug Administration (FDA) has agreed that the complete response and durability results from the UTOPIA trial may support the submission of a New Drug Application (NDA) for UGN-103 for this indication. UGN-103 is designed to provide manufacturing and reconstitution improvements over the currently approved ZUSDURI (mitomycin) while maintaining prolonged drug exposure within the bladder. The NDA submission is planned for 2026. The results were announced publicly and are based on preliminary data from the ongoing study.\n      \n\nDisclaimer: 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. 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