UroGen Pharma falls as FDA panel narrowly votes against bladder cancer drug

UroGen Pharma

22/05/2025 13:47

** U.S.-listed shares of biopharma firm UroGen Pharma UR8.F, URGN.O fall 3.4% to $4.03 premarket

** URGN said on Tuesday that U.S. FDA advisers narrowly voted against its experimental drug for a type of bladder cancer

** The drug, UGN-102, is under review for the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer(LG-IR-NMIBC)

** "While we are disappointed by (the) outcome, we continue to believe our clinical data support UGN-102 for the treatment of recurrent LG-IR-NMIBC, a disease with no FDA-approved therapies," said CEO Liz Barrett

** Brokerage Oppenheimer says "the committee expressed concern around the regulatory precedent that might be set should '102 be approved off its current dataset that relies on a single arm study for efficacy"

** FDA to decide on URGN's drug by June 13

** Oppenheimer says that a lack of randomized comparisons limits assessments of efficacy and safety

** As of last close, U.S.-listed shares has fallen ~70% YTD

 (Reporting by Siddhi Mahatole)

 ((siddhi.mahatole@thomsonreuters.com))