UroGen Pharma said on Friday it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for UGN-103, an investigational therapy for the treatment of non-muscle invasive bladder cancer (NMIBC).
The submission marks a key milestone for the biopharmaceutical company, which specializes in developing and commercializing innovative treatments for urologic diseases. UGN-103 is designed for intravesical administration, delivering a high-concentration formulation of mitomycin directly to the bladder to target cancerous tissue while minimizing systemic exposure.
If approved, UGN-103 would provide a new therapeutic option for patients with intermediate-risk NMIBC, a condition that affects an estimated 60,000 to 80,000 new cases annually in the United States. The company has not yet disclosed the FDA's Prescription Drug User Fee Act (PDUFA) target date for the review process.
UroGen's pipeline includes other investigational therapies, including UGN-301 for low-grade intermediate-risk NMIBC and UGN-201 for high-risk NMIBC. The company's focus on localized drug delivery aligns with its strategy to address unmet medical needs in urologic oncology.
Shares of UroGen were not immediately active in extended trading following the announcement. The company's market capitalization stands at approximately $120 million as of the latest close.
