0914 ET - An FDA advisory committee raised concerns about clinical trial design before narrowly voting no on whether the benefits of UroGen Pharma's UGN-102 outweighed its risks in treating recurrent low-grade, intermediate-risk, non-muscle invasive bladder cancer. A key factor was the single-arm design of the Phase 3 trail of UGN-102, which lacked a concurrent control arm, D. Boral analyst Jason Kolbert says in a research note. The FDA isn't bound by the committee's recommendation and will continue its review, Kolbert says. Based on the meeting dialogue and the data package that UroGen submitted, the chances of FDA approval for UGN-102 are actually better than the market seems to be indicating with recent share declines, Oppenheimer analysts say in a note. (dean.seal@wsj.com)

(END) Dow Jones Newswires

May 22, 2025 09:14 ET (13:14 GMT)

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