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UroGen Pharma Completes NDA Submission for UGN-102, Awaits FDA Decision by Q1 2025

Aug 14, 2024, 11:40 AM

UroGen Pharma has successfully completed the submission of its New Drug Application (NDA) for UGN-102, an investigational drug aimed at treating low-grade intermediate-risk non-muscle invasive bladder cancer. The company is ahead of schedule in this process and anticipates a potential FDA decision as early as the first quarter of 2025, assuming priority review. UroGen reported its 2024 second-quarter financial results, highlighting $241.3 million in cash and net product revenues of $21.8 million from JELMYTO®.