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Urovant Sciences Priced, Nasdaq: UROV

Phase 3 biotech developing an acquired oral therapy for overactive bladder.

Industry: Health Care

First Day Return: -16.8%

Industry: Health Care

We are a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions. Our product candidate, vibegron, is an oral, once-daily, small molecule that, based on in vitro data, is a potent and highly selective beta-3 agonist. We are currently evaluating it in our 1,400 patient, international pivotal Phase 3 clinical trial for the treatment of overactive bladder (OAB). We expect to report top-line results from this clinical trial in the first or second quarter of 2019 and, if the results are positive, we plan to submit an NDA to the FDA by early 2020. We believe vibegron may offer a differentiated profile compared to current OAB therapies, including the potential for broader efficacy claims if the FDA approves the inclusion of urgency data, rapid onset of action data, and a single convenient once-daily dose in the label. In addition to OAB, we are developing vibegron for two potential additional indications, the treatment of OAB in men with BPH and the treatment of IBS-associated pain. By the end of 2018, we expect to commence a Phase 3 clinical trial for OAB in men with BPH and a Phase 2a clinical trial for IBS-associated pain. We received an exclusive license to develop, manufacture and commercialize vibegron worldwide, excluding Japan and certain other Asian territories, pursuant to our license agreement with Merck.
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Urovant Sciences (UROV) Performance