UroGen Pharma Ltd. (URGN) has announced full-year 2025 financial results, highlighted by the commercial launch of ZUSDURI, alongside a refinancing of its term loan agreement with Pharmakon Advisors that strengthens its financial position.
For the fourth quarter of 2025, UroGen posted revenue of $37.8 million, up from $24.6 million in the same period of 2024.
Net loss narrowed to $26.4 million, or ($0.54) per share, compared with a net loss on $37.5 million, or ($0.80) per share earlier.
For the year ended December 31, 2025, UroGen reported total revenue of $109.8 million, up from $90.4 million in 2024.
Net loss widened to $153.5 million or ($3.19) per basic and diluted share, compared with a net loss of $126.9 million or ($2.96) per basic and diluted share in the prior year. Cash, cash equivalents, and marketable securities stood at $120.5 million at year-end.
ZUSDURI, the first and only FDA-approved therapy for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer, generated $15.8 million in net sales in 2025 during the launch period.
The product received a permanent J Code effective January 1, 2026, streamlining reimbursement and supporting broader patient access. By year-end UroGen reported 838 activated sites of care, 102 unique prescribers, and 32 repeat prescribers.
JELMYTO, approved for low-grade upper tract urothelial cancer, delivered $94 million in net sales in 2025, representing 7% year-over-year growth. Guidance for 2026 calls for JELMYTO sales in the range of $97 to $101 million, compared to $94 million in 2025.
Pipeline progress included strong results from the Phase 3 UTOPIA trial of UGN-103, showing a 77.8% three-month complete response rate. UroGen plans to submit an NDA in the second half of 2026, with potential FDA approval in 2027. The company is also advancing UGN-104 in a Phase 3 trial expected to be fully enrolled by the end of 2026.
And UGN-501, an investigational oncolytic virus therapy, with Phase 1 initiation targeted by late 2026.
Separately, UroGen announced it has refinanced its term loan agreement with Pharmakon Advisors, securing up to $250 million in senior secured debt.
The first tranche of $200 million refinanced an existing $125 million facility and provided additional non-dilutive capital, while a second $50 million tranche remains available until June 2027. The loan carries a fixed interest rate of 8.25% and extends amortization to 2030.
CEO Liz Barrett described 2025 as a "transformative year," citing the FDA approval and launch of ZUSDURI, continued growth of JELMYTO, and strengthened balance sheet through refinancing. She emphasized that 2026 will be pivotal for ZUSDURI's trajectory and for advancing next-generation pipeline programs.
URGN has traded between $3.42 and $30.00 over the past year. The stock closed Monday's session at $19.02, down 12.35%. In after-hours, the stock rose 4.36% to $19.85.
For comments and feedback contact: editorial@rttnews.com
Business News
June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.