Urovant Ph III vibegron study meets goals, but fails to impress investors

19 March 2019

Urovant Sciences (Nasdaq: UROV), a Roivant Sciences company, today released Phase III clinical trial results of vibegron for the treatment of patients with overactive bladder (OAB) which, while seen as positive by the company, failed to impress investors, and the firm’s shares plunged 22.69% to $10.72 by mid-morning trading.

Urovant today announced top-line results from EMPOWUR, an international double-blind, placebo-controlled, multicenter Phase III clinical trial evaluating the efficacy and safety of vibegron 75mg in adults with symptoms of overactive bladder. Vibegron, which was licensed from Merck & Co (NYSE: MRK) in 2017, is an investigational once-daily oral beta-3 adrenergic agonist.

Based on these top-line results, Urovant intends to file a New Drug Application (NDA) with the US Food and Drug Administration by early 2020. EMPOWUR results will be presented at the American Urological Association Annual Meeting in Chicago in May of this year.

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