---
title: "UroGen submits FDA NDA for UGN-103 bladder cancer treatment"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/296102469.md"
description: "UroGen Pharma has submitted a New Drug Application (NDA) to the FDA for UGN-103, an investigational intravesical mitomycin treatment for recurrent low-grade non-muscle invasive bladder cancer. The submission is supported by Phase 3 UTOPIA trial data demonstrating a 77.8% complete response rate at three months and a 94.5% six-month duration of response."
datetime: "2026-08-17T12:04:11.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/296102469.md)
  - [en](https://longbridge.com/en/news/296102469.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/296102469.md)
generator: "portal-rs"
---

# UroGen submits FDA NDA for UGN-103 bladder cancer treatment

-   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. © Copyright 2026 - Public Technologies (PUBT)

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