UroGen Reports 94.5% Six-Month Duration of Response in Phase 3 UTOPIA Trial, Advancing UGN-103 Toward Potential Approval in Recurrent Low-Grade Intermediate-Risk NMIBC
View original at globenewswire.comUroGen Reports 94.5% Six-Month Duration of Response in Phase 3 UTOPIA Trial, Advancing UGN-103 Toward Potential Approval in Recurrent Low-Grade Intermediate-Risk NMIBC PRINCETON, N.J., May 15, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd…
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UroGen remains on track to submit an NDA for UGN-103 in Q3 2026 based on UTOPIA-ENVISION data consistency and FDA alignment
60% confidenceUGN-103 six-month DOR in UTOPIA is consistent with ENVISION ZUSDURI results and highlights potential to advance care for recurrent LG-IR-NMIBC patients; builds on proven therapeutic approach with meaningful innovations
60% confidenceUroGen holds U.S. patents on RTGel combined with medac's lyophilized mitomycin formulation and on use of UGN-103 in LG-IR-NMIBC, with IP protection expected to extend into December 2041
60% confidenceLG-IR-NMIBC affects ~82,000 Americans annually, ~59,000 recurrent; median diagnosis age 73 years; up to 70% of NMIBC patients experience at least one recurrence
60% confidenceUGN-103 achieved 94.5% (95% CI: 86.1, 97.9) durability of response at six months in UTOPIA, consistent with 91.9% (95% CI: 86.9, 95.0) six-month DOR in ZUSDURI's ENVISION trial
60% confidenceUTOPIA data reinforce UGN-103's potential as new standard of care; UroGen advancing with urgency toward NDA submission with FDA alignment; UGN-103 represents significant opportunity to build leadership in uro-oncology and drive long-term growth
60% confidence