URGN News & Events

UroGen Pharma announced UGN-103 achieved a 94.5% durability of response at six months by Kaplan-Meier estimate, in the ongoing Phase 3 UTOPIA trial of UGN-103 for intravesical solution in patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. The six-month results from UTOPIA are generally consistent with the 91.9% six-month DOR observed with Zusduri for intravesical therapy in its pivotal ENVISION trial. Zusduri is the first and only treatment approved by the 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 for UGN-103 in the third quarter of 2026.

UroGen Pharma announced a 36-month duration of response of 64.5% by Kaplan-Meier estimate in patients who achieved a complete response at three months in the pivotal Phase 3 ENVISION trial of Zusduri for intravesical solution. "The ENVISION 36-month DOR data reinforce ZUSDURI's potential to shift the treatment paradigm for recurrent LG-IR-NMIBC," said Mark Schoenberg, chief medical officer, UroGen. "By delivering durable responses without maintenance therapy, ZUSDURI provides an opportunity to move beyond the cycle of repeated surgical interventions and toward a more durable, lower-burden treatment approach over time."