UroGen Pharma rises on FDA approval for bladder cancer drug

UroGen Pharma

12/06/2025 19:19

** U.S.-listed shares of UroGen Pharma UR8.F, URGN.O rise 48.5% to $10.52

** The FDA says it approved co's drug to treat a type of bladder cancer

** The approval comes despite its panel of external advisors last month narrowly voting against backing the drug as the members criticized the single-arm trial for the drug

** The drug, branded as Zusduri, will be the first to get approval to treat a type of bladder cancer that has not spread beyond the inner layers of the organ, and which primarily affects older people

** Approval based on late-stage study on 223 patients, in which 78% showed a complete response to the drug - FDA

** Including session's moves, stock down 32.7% YTD

(Reporting by Siddhi Mahatole)

((siddhi.mahatole@thomsonreuters.com))