UroGen Pharma Gets FDA Clearance to Begin Phase 1 Trial of UGN-501

MT Newswires Live

07/08

UroGen Pharma (URGN) said Wednesday the US Food and Drug Administration cleared its investigational new drug application for UGN-501, allowing the company to begin a phase 1 trial in patients with non-muscle invasive bladder cancer.

The company said patient enrollment in the phase 1 study is expected to begin in Q4 2026 and will evaluate the safety, tolerability and feasibility of intravesical administration of UGN-501.

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