The six-month results from UTOPIA are generally consistent with the 91.9% (95% CI: 86.9, 95.0) six-month DOR observed with ZUSDURI™ (mitomycin) for intravesical therapy in its pivotal ENVISION trial. ZUSDURI is the first and only treatment approved by the U.S. Food and Drug Administration (FDA) for adult patients with recurrent LG-IR-NMIBC.

Based on the consistency of UTOPIA data with the results of the ENVISION trial studying ZUSDURI in patients meeting the same eligibility criteria and alignment with the FDA, UroGen remains on track to submit a New Drug Application (NDA) for UGN-103 in the third quarter of 2026.

"The durability of response observed at six months with UGN-103 in the UTOPIA trial is generally consistent with that observed in the pivotal ENVISION trial of ZUSDURI, and highlights the potential to further advance care for adult patients with recurrent LG-IR-NMIBC," said Abishek Srivastava, MD, Urologic Oncologist at Atlantic Urology Clinics, Myrtle Beach, SC, START Center for Cancer Research, Carolinas and lead investigator of the UTOPIA trial. "UGN-103 builds on a proven therapeutic approach with meaningful innovations that could help enhance how we deliver this therapy in clinical practice."

UGN-103 is designed to build on the clinical and commercial foundation of ZUSDURI. The benefits of UGN-103 include a more streamlined manufacturing process and simplified reconstitution, while preserving the innovative and proven RTGel® technology that enables sustained drug exposure at tumor sites in the bladder.

"These clinical data reinforce the potential of UGN-103 to become a new standard of care for adult patients with recurrent LG-IR-NMIBC," said Liz Barrett, President and Chief Executive Officer of UroGen. "With FDA alignment on our regulatory path, we are advancing with urgency toward NDA submission. We believe UGN-103 represents a significant opportunity to build on our leadership in uro-oncology, expand our commercial portfolio, and drive long-term growth."

UroGen holds U.S. patents covering the combination of its proprietary RTGel technology with medac's licensed lyophilized mitomycin formulation, as well as the use of UGN-103 in LG-IR-NMIBC, with intellectual property protection expected to extend into December 2041.