UroGen submits FDA NDA for UGN-103 bladder cancer treatment

Reuters2026/08/17 12:04

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UroGen Pharma filed an FDA New Drug Application for UGN-103, an investigational intravesical mitomycin for recurrent LG-IR-NMIBC.
Submission backed by Phase 3 UTOPIA data showing 77.8% complete response at three months, 94.5% six-month duration of response.

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: 202608170800PRIMZONEFULLFEED9810741) on August 17, 2026, and is solely responsible for the information contained therein.

Disclaimer: The content of this article solely reflects the author's opinion and does not represent the platform in any capacity. This article is not intended to serve as a reference for making investment decisions.

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UroGen submits FDA NDA for UGN-103 bladder cancer treatment

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