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Note 1 - Business and Nature of Operations | 3 Months Ended
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Mar. 31, 2026
Notes to Financial Statements |
Nature of Operations [Text Block] | Note 1 – Business and Nature of Operations Nature of Operations UroGen Pharma Ltd. is an Israeli company incorporated in April 2004 (“UPL”). UroGen Pharma, Inc., a wholly owned subsidiary of UPL, was incorporated in Delaware in October 2015 and began operating in February 2016 (“UPI”). UPL and UPI (together the “Company”) is a biotechnology company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers. Since commencing operations, the Company has devoted substantially all of its efforts to securing intellectual property rights, performing research and development activities, including conducting clinical trials and manufacturing activities, hiring personnel, launching the Company’s first commercial product, Jelmyto (mitomycin) for pyelocalyceal solution, developing and securing regulatory approval of and commercializing Zusduri (mitomycin) for intravesical solution, formerly known as UGN-102, and raising capital to support and expand these activities. On April 15, 2020, the U.S. Food and Drug Administration (“FDA”) granted approval for Jelmyto, a first-in-class treatment indicated for adults with low-grade upper tract urothelial cancer (“low-grade UTUC”). Jelmyto consists of mitomycin, an established chemotherapy, and sterile hydrogel, using the Company's proprietary sustained release RTGel technology. It has been designed to enable longer exposure of urinary tract tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. On June 12, 2025, the FDA approved Zusduri, the first and only FDA-approved medication for adults with recurrent low-grade intermediate risk non-muscle invasive bladder cancer (“low-grade intermediate risk NMIBC”). Zusduri consists of mitomycin and sterile hydrogel, using the Company’s proprietary sustained release RTGel technology, and is delivered directly into the bladder in an out-patient procedure by a trained healthcare professional using a urinary catheter to enable the treatment of tumors by non-surgical means.

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