---
title: "UroGen Reports 77.8% Three-Month Complete Response Rate from Phase 3 UTOPIA Trial of UGN-103 and Receives FDA Agreement on NDA Submission Strategy in Recurrent LG-IR-NMIBC Based on UTOPIA Trial"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/264669742.md"
description: "PRINCETON, N.J., Nov. 06, 2025 ( GLOBE NEWSWIRE ) -- UroGen Pharma Ltd. ( Nasdaq: URGN ) , a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced robust preliminary results from its ongoing Phase 3 UTOPIA ..."
datetime: "2025-11-06T13:33:20.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/264669742.md)
  - [en](https://longbridge.com/en/news/264669742.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/264669742.md)
---

> Supported Languages: [简体中文](https://longbridge.com/zh-CN/news/264669742.md) | [繁體中文](https://longbridge.com/zh-HK/news/264669742.md)


# UroGen Reports 77.8% Three-Month Complete Response Rate from Phase 3 UTOPIA Trial of UGN-103 and Receives FDA Agreement on NDA Submission Strategy in Recurrent LG-IR-NMIBC Based on UTOPIA Trial

PRINCETON, N.J., Nov. 06, 2025 ( GLOBE NEWSWIRE ) -- UroGen Pharma Ltd. ( Nasdaq: URGN ) , a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced robust preliminary results from its ongoing Phase 3 UTOPIA ...

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