UroGen Pharma Ltd. (URGN) Launches uTRACT Registry to Track JELMYTO Use in UTUC

UroGen Pharma Ltd. (NASDAQ:URGN) has unveiled the design of its pivotal uTRACT Registry study at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, marking a major step forward in the fight against low-grade upper tract urothelial carcinoma (LG-UTUC).

The uTRACT Registry is a nationwide, multicenter study tracking real-world outcomes for JELMYTO (mitomycin), a novel chemoablative therapy approved for LG-UTUC.

UroGen Pharma Ltd. (URGN) Launches uTRACT Registry to Track JELMYTO Use in UTUC

A scientist in a laboratory, monitoring the development of a new drug.

As of May 2025, 274 patients have been enrolled across 22 U.S. sites, with a target of 400 participants. The study collects comprehensive, three-year data on patient history, treatment protocols, and clinical outcomes, including recurrence rates, response duration, and safety.

JELMYTO, a reverse thermal gel, is designed to deliver targeted chemotherapy directly to the upper urinary tract, offering a minimally invasive alternative to surgery.

With up to 7,000 Americans diagnosed with LG-UTUC annually, most of them elderly and facing limited treatment options, UroGen Pharma Ltd. (NASDAQ:URGN)’s registry aims to define best practices and improve patient outcomes. The data could reshape LG-UTUC management, offering hope for safer, more effective therapies.

UroGen Pharma Ltd. (NASDAQ:URGN) is a biotech company focused on innovative treatments for urothelial and specialty cancers. Its proprietary RTGel technology enables sustained drug release for longer exposure in the urinary tract, enhancing treatment effectiveness. UroGen’s lead therapies include JELMYTO for low-grade upper tract urothelial cancer (LG-UTUC) and UGN-102, an investigational non-surgical treatment for low-grade non-muscle invasive bladder cancer. It is headquartered in Princeton, NJ, and also operates in Israel.

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