UroGen Initiates Submission Of A Rolling NDA To The FDA For UGN-102
Portfolio Pulse from Benzinga Newsdesk
UroGen Pharma Ltd. has initiated the submission of a rolling New Drug Application (NDA) to the FDA for UGN-102, a treatment for low-grade, intermediate-risk non-muscle invasive bladder cancer. The company submitted the Chemistry, Manufacturing, and Controls (CMC) section and plans to complete the NDA in 2024, with a potential FDA decision by early 2025. UGN-102 utilizes UroGen's RTGel technology for sustained release and is currently in Phase 3 development.
January 24, 2024 | 1:18 pm
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UroGen Pharma has started the rolling NDA process with the FDA for UGN-102, which could lead to a new treatment option for bladder cancer by 2025.
The initiation of the rolling NDA submission is a positive development for UroGen, indicating progress in the regulatory process. This news is likely to be viewed favorably by investors as it represents a step forward in bringing a new cancer treatment to market. The potential approval of UGN-102 could have a significant impact on the company's future revenues and growth prospects.
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