UroGen Pharma Ltd.
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- UroGen Pharma Ltd. is a biotechnology firm dedicated to advancing innovative therapeutic options for specific cancers and conditions affecting the urothelium. The company leverages its proprietary RTGel, a unique polymeric, reverse-thermal hydrogel, which transforms from a liquid into a gel at body temperature, to enhance the delivery and sustained exposure of therapeutic agents. Among its commercial offerings is Jelmyto, a mitomycin-based pyelocalyceal solution, specifically indicated for the treatment of low-grade upper tract urothelial carcinoma (LG-UTUC). More recently, the company expanded its portfolio with the FDA approval of ZUSDURI™ (mitomycin) for intravesical solution, addressing recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The development pipeline includes UGN-103, a next-generation mitomycin formulation utilizing the RTGel technology, currently progressing towards a Phase 3 study for LG-IR-NMIBC, with the FDA having agreed to an NDA submission strategy for the second half of 2026. Another advanced candidate, UGN-104, also a mitomycin-based formulation, is anticipated to commence Phase 3 trials in early 2025 for LG-UTUC. Beyond these, UroGen is exploring UGN-301, an anti-CTLA-4 monoclonal antibody administered intravesically in Phase 1 trials for high-grade non-muscle invasive bladder cancer (HG-NMIBC). The company is also developing UGN-501, an investigational oncolytic virus, with IND-enabling studies projected to begin in 2025. UroGen maintains strategic collaborations, including a license and supply agreement with medac GmbH for next-generation mitomycin-based formulations, potentially extending patent protection for these programs until 2041. The company was established in 2004 and is headquartered in Princeton, New Jersey, with active operations in Israel.
UroGen Pharma: Reimbursement Is Turning Zusduri Into A Workflow Moat
UroGen Receives New U.S. Patent Allowance Expected to Provide Protection into July 2044 for ZUSDURI™ and UGN-103
UroGen's Chief Medical Officer Sold $400,000 in Stock After a 191% Run
UroGen Announces FDA Clearance of the IND for UGN-501, an Investigational Next-Generation Oncolytic Virus for Non-Muscle Invasive Bladder Cancer
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UroGen Pharma Ltd. (URGN) Presents at Goldman Sachs 47th Annual Global Healthcare Conference 2026 Transcript
UroGen Pharma Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
UroGen Announces Agreement Resolving Patent Litigation Relating to JELMYTO® (mitomycin) for pyelocalyceal solution
UroGen Pharma to Present at the Goldman Sachs 47th Annual Global Healthcare Conference
UroGen Pharma to Present at the Goldman Sachs 47th Annual Global Healthcare Conference
UroGen Pharma Ltd. (URGN) Discusses Real-World Experiences and Outcomes With ZUSDURI for Recurrent Bladder Cancer Transcript
UroGen Reports 94.5% Six-Month Duration of Response in Phase 3 UTOPIA Trial, Advancing UGN-103 Toward Potential Approval in Recurrent Low-Grade Intermediate-Risk NMIBC
UroGen Pharma Ltd. (URGN) Presents at Bank of America Global Healthcare Conference 2026 Transcript
ZUSDURI Median Duration of Response Still Not Reached with 64.5% 36-month Duration of Response in the Pivotal ENVISION Trial
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UroGen Q1 Review: Zusduri Launch Accelerates, With Profitability Anticipated By 2027
UroGen Pharma to Present at Upcoming Investor Conferences
UroGen Pharma Ltd. (URGN) Q1 2026 Earnings Call Transcript