UroGen Submits Completed UGN-102 NDA Seeking Approval as the First FDA-Approved Treatment for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

UroGen Pharma Ltd. submitted the NDA for UGN-102 (mitomycin) for intravesical solution, aiming to treat low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The NDA is supported by the Phase 3 ENVISION study, which showed a 79.6% complete response rate at three months and an 82.3% 12-month duration of response. UroGen anticipates FDA approval in early 2025, potentially offering an alternative to repeated surgeries.