UroGen Pharma Ltd. has announced preliminary results from its ongoing Phase 3 UTOPIA trial, evaluating UGN-103 (mitomycin) for intravesical solution in patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The trial demonstrated a 77.8% three-month complete response rate (95% CI, 68.3%, 85.5%). The company also reported that the U.S. Food and Drug Administration (FDA) has agreed that the complete response and durability results from the UTOPIA trial may support the submission of a New Drug Application (NDA) for UGN-103 for this indication. UGN-103 is designed to provide manufacturing and reconstitution improvements over the currently approved ZUSDURI (mitomycin) while maintaining prolonged drug exposure within the bladder. The NDA submission is planned for 2026. The results were announced publicly and are based on preliminary data from the ongoing study.