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 ...
UroGen Pharma Ltd. - Ordinary Shares (URGN)
Last urogen pharma ltd. - ordinary shares earnings: 3/2 08:00 am
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Source: GlobeNewswire
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 trial, demonstrating a 77.8% three-month complete response (CR) rate (95% CI, 68.3%, 85.5%) with UGN-103 (mitomycin) for intravesical solution in patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). This result is consistent with the 79.6% three-month CR rate (95% CI, 73.9%, 84.5%) observed following treatment with ZUSDURI in the pivotal ENVISION trial. In addition, the U.S. Food and Drug Administration (FDA) agreed that CR and durability results from the UTOPIA trial can support the submission of a New Drug Application (NDA) for UGN-103 for recurrent LG-IR-NMIBC. “The robust 77.8% three-month CR rate observed in the UTOPIA trial is highly encouragin
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News
- UroGen Pharma Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)GlobeNewswire
- UroGen Pharma to Present at the Piper Sandler 37th Annual Healthcare Conference [Yahoo! Finance]Yahoo! Finance
- UroGen Pharma to Present at the Piper Sandler 37th Annual Healthcare ConferenceGlobeNewswire
- UroGen Pharma (URGN) Closes Q3 2025 With $127.4 Million in Cash Amid Rising R&D Costs [Yahoo! Finance]Yahoo! Finance
- Analysts Have Made A Financial Statement On UroGen Pharma Ltd.'s (NASDAQ:URGN) Third-Quarter Report [Yahoo! Finance]Yahoo! Finance
URGN
Earnings
- 11/6/25 - Beat
URGN
Analyst Actions
- 10/27/25 - HC Wainwright
URGN
Sec Filings
- 12/1/25 - Form 4
- 12/1/25 - Form 4
- 12/1/25 - Form 4
- URGN's page on the SEC website