UroGen activated 838 sites of care and enrolled 102 unique prescribers for Zusduri by December 31, 2025, with over 95% of covered lives granted open access following the permanent J-code rollout. New and repeat prescribers, patient enrollment forms, and new patient starts accelerated since the J-code took effect on January 1, 2026, eliminating key reimbursement barriers. Hospital-type and community settings mix shifted from 60/40 to roughly 50/50 by late February.

ENVISION trial data for Zusduri demonstrated an approximately 80% complete response rate at three months, with Kaplan-Meier estimates showing an 80% event-free probability at 12 months and 72% at 24 months. Physicians reported predictable workflows and valued the six-dose outpatient regimen that avoids surgery or maintenance therapy. Early adopter feedback highlighted patient preference for a non-surgical option after multiple TURBT procedures.

Total 2025 revenue rose to $109.8 million from $90.4 million in 2024, driven by a $15.8 million Zusduri launch and $94.0 million in Jelmyto sales. Q3 net product revenue for Zusduri was $1.8 million and Q4 reached $14.0 million. UroGen reported a net loss of $153.5 million, or $3.19 per share, and closed the year with $120.5 million in cash, equivalents, and marketable securities. A refinancing with Pharmakon Advisors strengthened the balance sheet.

UGN-103 Phase 3 UTOPIA trial achieved a 77.8% complete response rate at three months, paving the way for an NDA submission in the second half of 2026 and potential approval in 2027. The company plans randomized, controlled trials for high-grade NMIBC in H2 2026, subject to FDA alignment. Enrollment for UGN-104 Phase 3 is expected to complete by end-2026, while IND-enabling studies for UGN-501 continue ahead of a planned 2026 Phase 1 trial.