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.
Company News
UroGen Announces FDA Acceptance of the New Drug Application for UGN-103, an Investigational Treatment for Adults with Recurrent LG-IR-NMIBC
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UroGen Announces Strategic Collaboration and Investment Agreements with IntraGel to Access Biodegradable Sustained-Release Gel Platform and Expand Oncology Pipeline
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