UroGen Announces FDA Acceptance of the New Drug Application for UGN-103, an Investigational Treatment for Adults with Recurrent LG-IR-NMIBC

PRINCETON, N.J., Oct. 19, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced U.S. Food and Drug Administration (FDA) acceptance of the New Drug Application (NDA) for investigational drug UGN-103 (mitomycin) for intravesical solution for the treatment of adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 14, 2027.

“FDA acceptance of the UGN-103 NDA advances our vision for the next evolution of our portfolio and our continued commitment to transforming the treatment of recurrent LG-IR-NMIBC,” said Liz Barrett, President and CEO, UroGen. “Building on our experience with ZUSDURI (mitomycin) for intravesical solution, UGN-103 combines our proprietary RTGel(®) technology with a novel mitomycin formulation, which leverages a streamlined manufacturing process and simplified reconstitution. We look forward to working closely with the FDA during its review and remain focused on delivering innovative treatment options for people living with this highly recurrent disease.”