** 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))
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