UroGen Pharma Says FDA Accepts New Drug Application for UGN-103 in Bladder Cancer

09:07 AM EDT, 10/19/2026 (MT Newswires) -- UroGen Pharma (URGN) said Monday that the US Food and Drug Administration has accepted its new drug application for UGN-103 to treat adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. The company said the agency has set a Prescription Drug User Fee Act target action date of June 14, 2027. UroGen said the application was based on clinical data from an ongoing phase 3 trial that showed UGN-103 achieved a 77.8% complete response rate at three months, with 94.5% Kaplan-Meier probability of remaining event-free at six months.