09:02 AM EDT, 04/15/2024 (MT Newswires) -- UroGen Pharma ( URGN ) said Monday that the US Food and Drug Administration has accepted its Investigational New Drug application for UGN-103, a potential treatment for low-grade intermediate-risk non-muscle invasive bladder cancer.

UroGen said it plans to launch a phase 3 study this year to test the safety and effectiveness of its mitomycin-based formulation of UGN-103.

Meanwhile, the company said it is seeking to complete its New Drug Application submission for UGN-102, another mitomycin formulation, in September.

Shares of UroGen were up 4.6% in recent Monday premarket activity.

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