UroGen reported FY 2025 revenue of USD 109.8 million, up 21% year-over-year, and a FY net loss of USD 153.5 million (USD 3.19 per share). FY 2025 R&D expenses were USD 67.1 million and SG&A expenses were USD 155.1 million, while cash, cash equivalents and marketable securities totaled USD 120.5 million as of Dec. 31, 2025. For Q4 2025, revenue was USD 37.8 million and net loss was USD 26.4 million. In commercial updates, ZUSDURI net product sales were USD 15.8 million in FY 2025 following FDA approval on June 12, 2025; the permanent J Code (J9282) became effective Jan. 1, 2026. As of Dec. 31, 2025, UroGen reported 838 activated sites of care, 102 unique ZUSDURI prescribers and 32 repeat prescribers. JELMYTO net product sales were USD 94.0 million in FY 2025, with underlying demand revenue growth of 7%. UroGen guided FY 2026 JELMYTO net product sales of USD 97 million to USD 101 million and expects FY 2026 operating expenses of USD 240 million to USD 250 million. Pipeline and corporate highlights included Phase 3 UTOPIA results for UGN-103 showing a 77.8% three-month complete response rate (95% CI: 68.3% to 85.5%), with an NDA submission planned in H2 2026 and potential FDA approval in 2027; UGN-104’s Phase 3 trial is expected to be fully enrolled by end-2026. The company also said IND-enabling studies for UGN-501 are ongoing with the goal of submitting an IND and initiating a Phase 1 trial by end-2026. Separately, UroGen announced a refinancing and expansion of its Pharmakon Advisors term loan, including a USD 200 million tranche funded at closing on Feb. 26, 2026 and an additional optional USD 50 million tranche available through June 30, 2027, with interest at a fixed 8.25% and repayments beginning in Q1 2030.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Urogen Pharma Ltd. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202603020800PRIMZONEFULLFEED9663306) on March 02, 2026, and is solely responsible for the information contained therein.