UroGen Completes Enrollment of Its Phase 3 Clinical Trial for UGN-102 in Development for Low-Grade, Intermediate-Risk, Non-Muscle Invasive Bladder Cancer (LG-IR-NMIBC)
UroGen Pharma Ltd. - Ordinary Shares (URGN)
Last urogen pharma ltd. - ordinary shares earnings: 3/2 08:00 am
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Source: Business Wire
--If approved, UGN-102 would be the first non-surgical primary therapeutic to treat a subset of bladder cancer characterized by high recurrence rates and multiple surgeries PRINCETON, N.J.--(BUSINESS WIRE)--UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, announced that the Phase 3 ENVISION study of investigational agent UGN-102 (mitomycin) for intravesical solution in development for the treatment of LG-IR-NMIBC is fully enrolled. The ENVISION study targeted enrollment of 220 patients across 90 sites and, assuming positive findings, UroGen anticipates submitting a New Drug Application (NDA) for UGN-102 in 2024.“Completing enrollment for the ENVISION trial is a major milestone that brings us one step closer to validating chemoablation for the treatment of LG-IR-NMIBC,” said Sandip Prasad, M.D., M.Phil., Director of Genitourinary Surgical Oncology, Morristown Medical Cen
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News
- UroGen Pharma Ltd. (NASDAQ: URGN) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $54.00 price target on the stock.MarketBeat
- UroGen Announces New Data Presentations at the American Urological Association 2024 Annual Meeting Highlighting Clinical Benefits of Our Portfolio for Urothelial Cancers [Yahoo! Finance]Yahoo! Finance
- UroGen Announces New Data Presentations at the American Urological Association 2024 Annual Meeting Highlighting Clinical Benefits of Our Portfolio for Urothelial CancersBusiness Wire
- UroGen Announces FDA Acceptance of Investigational New Drug Application for UGN-103, a Next Generation Mitomycin-Based Formulation for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer [Yahoo! Finance]Yahoo! Finance
- UroGen Announces FDA Acceptance of Investigational New Drug Application for UGN-103, a Next Generation Mitomycin-Based Formulation for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder CancerBusiness Wire
URGN
Earnings
- 3/14/24 - Miss
URGN
Sec Filings
- 3/20/24 - Form 4
- 3/18/24 - Form 144
- 3/14/24 - Form 10-K
- URGN's page on the SEC website