Strong Q1 Revenue Growth
Total revenue of $51.0M in Q1 2026 versus $20.3M in Q1 2025, a 152% year-over-year increase driven primarily by the commercial launch of ZUSDURI and JELMYTO.
ZUSDURI Early Launch Momentum
ZUSDURI generated $29.2M in Q1 2026, representing more than 100% quarter-over-quarter growth as reported; adoption metrics improved meaningfully with 256 unique prescribers (up from 102 at year-end, ~+151%) and 103 repeat prescribers (up from 32, ~+222%).
Improving Commercial Conversion and Channel Mix
Cycle time from patient enrollment form (PEF) to treatment improved from ~45–60 days in Q4 to ~30–35 days in Q1, with a target steady-state of 2–3 weeks. Mix shifted from ~60% hospital/40% community in Q4 toward ~50/50 in Q1, unlocking community access where ~70% of the market resides.
JELMYTO Stability and Guidance
JELMYTO revenue of $21.7M in Q1 2026 with stable, predictable demand. Full-year 2026 JELMYTO net product revenue guidance of $97M–$101M, implying ~3%–7% year-over-year growth.
Pipeline Progress and Near-Term Regulatory Milestones
UGN-103 (next-generation mitomycin) showed a 77.8% complete response at 3 months in Phase III UTOPIA; NDA planned in H2 2026 with 6-month durability data expected midyear and potential approval in 2027 (permanent J-code possibly early 2028). UGN-104 Phase III enrollment expected to complete by end of 2026. UGN-501 IND expected in Q2 2026 with Phase I initiation in NMIBC by year-end.
Clinical Durability and Published Data
ENVISION (ZUSDURI) showed ~80% complete response at 3 months and ~72% event-free probability at 24 months (Kaplan-Meier), with median duration of response not reached at median follow-up of 23.7 months; data published in Journal of Urology and to be presented at AUA.
Improved Financial Position and Reduced R&D Spend
Cash, cash equivalents and marketable securities totaled $140.3M as of March 31, 2026, supported by term loan refinancing. R&D expenses declined to $15.6M in Q1 2026 from $19.9M in Q1 2025 (≈-22%), reflecting prior-period items and program timing.
Smaller Net Loss Versus Prior Year
Net loss improved to $23.6M ($0.47 per share) in Q1 2026 versus a net loss of $43.8M ($0.92) in Q1 2025, roughly a 46% reduction in the quarterly loss.