UGN-103 - (UTOPIA)

August 5, 2026: UroGen Pharma Ltd. (NASDAQ: URGN) reported Q2 2026 business updates across commercial and pipeline programs. ZUSDURI (mitomycin) for recurrent low-grade intermediate-risk NMIBC generated $50.4 million in Q2 revenue, up 73% vs. Q1 2026. Updated Phase 3 ENVISION data showed 79.6% complete response at 3 months; among responders, 36-month duration of response was 64.5% (95% CI: 54.6, 72.8), with median DOR not reached at 35.5 months. The USPTO issued a Notice of Allowance for a patent covering treatment without TURBT; once issued, protection is expected into July 2044 for ZUSDURI and UGN-103.

JELMYTO for low-grade upper tract urothelial cancer generated $22.0 million in Q2 revenue. UroGen also settled patent litigation with Teva, granting a non-exclusive license for generic JELMYTO entry beginning September 15, 2030, if FDA-approved.

UGN-103, in Phase 3 UTOPIA for LG-IR-NMIBC, showed 94.5% 6-month DOR (95% CI: 86.1, 97.9). The company remains on track for an NDA submission in Q3 2026, with potential FDA approval in 2027. A randomized Phase 3 trial in high-risk NMIBC is expected to start in 2H 2026, and an adjuvant trial in newly diagnosed intermediate-risk NMIBC in 2027.

UGN-104 remains on track to complete Phase 3 enrollment in LG-UTUC by year-end 2026. UGN-501’s IND was accepted by FDA, with a Phase 1 NMIBC trial planned for Q4 2026.