UroGen Pharma Ltd. (URGN) has announced that the U.S. Food and Drug Administration (FDA) has accepted their New Drug Application (NDA) for the investigational drug UGN-102 (mitomycin), intended as an intravesical solution. If approved, UGN-102 could be the first FDA-sanctioned treatment for low-grade intermediate-risk non-muscle invasive bladder cancer.
The FDA has slated a Prescription Drug User Fee Act (PDUFA) target date of June 13, 2025, for this application.
UGN-102 (mitomycin) as an intravesical solution represents an innovative formulation currently undergoing regulatory evaluation. It is designed specifically to treat low-grade intermediate-risk non-muscle invasive bladder cancer. Should the drug receive approval, it is poised to address a U.S. market valued at approximately $5 billion.
