India, Oct. 19 -- UroGen Pharma Ltd. (URGN), a biotechnology company focused on urothelial and specialty cancers, announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for UGN-103, an investigational treatment for 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.
The NDA is supported by data from the ongoing Phase 3 UTOPIA trial, a single-arm, multicenter study evaluating the efficacy and safety of UGN-103 in 99 adults with recurrent LG-IR-NMIBC.
According to the company, UGN-103 achieved a complete response rate of 77.8% at three months. Amon...