09:14 AM EDT, 08/14/2024 (MT Newswires) -- UroGen Pharma ( URGN ) said Wednesday it has submitted a new drug application, or NDA, to the US Food and Drug Administration for UGN-102, an investigational treatment for low-grade intermediate-risk non-muscle invasive bladder cancer.

The company said the NDA is backed by data from a phase 3 trial, which showed a 79.6% complete response rate three months after treatment, with an 82.3% response duration lasting up to 12 months.

If the NDA is accepted and granted priority review, UroGen expects potential FDA approval in early 2025, the company said.

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