Urovant Sciences, a wholly-owned subsidiary of Sumitovant Biopharma Ltd., today announced positive topline results from its Phase 2a, double-blind, placebo-controlled exploratory study of URO-902, an investigational, novel, locally injected gene therapy product (plasmid human cDNA encoding maxi-K channel), in patients with overactive bladder (OAB), who were not well managed by oral therapies. Read more.
Source: Pharmiweb.com, March 7, 2022
Urovant Sciences, a biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions, today announced the commercial launch of GEMTESA® (vibegron) 75 mg tablets, a beta-3 (β3) adrenergic receptor agonist, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency in adults. Read more.
Source: Business Wire, April 12, 2021
Urovant Sciences, Inc (Nasdaq: UROV) announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for once-daily 75 mg GEMTESA® (vibegron), a beta-3 adrenergic receptor (β3) agonist, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency in adults. Read more.
Source: BioSpace, December 23, 2020
Urovant Sciences (Nasdaq: UROV) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s New Drug Application (NDA) for once-daily 75 mg vibegron for the treatment of patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. The NDA has been assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 26, 2020. In addition, the FDA has communicated that they are not currently planning to hold an Advisory Committee meeting to discuss the application. Read more.
Source: Businesswire, March 5, 2020
Urovant Sciences has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for vibegron, a beta-3 adrenergic agonist, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. The NDA submission includes data from an extensive clinical development program involving over 4000 patients with OAB. Results from the pivotal 12-week phase 3 EMPOWUR study support the efficacy and safety of vibegron in 1518 patients randomized to receive either vibegron 75mg once daily, placebo, or tolterodine extended-release 4mg once daily. Read more.
Source: MPR, January 2, 2020
Urovant Sciences, a clinical-stage biopharmaceutical company focused on developing novel therapies for urologic conditions, today announced that Kyorin Pharmaceutical Co., Ltd. (Kyorin) received marketing approval from Japan’s Ministry of Health, Labour and Welfare for vibegron for the treatment of adults with overactive bladder (OAB) in Japan. Kyorin licensed vibegron for Japan from Merck & Co., Inc. in 2014, and later expanded the license to include certain other Asian countries in 2017. Urovant licensed rights to vibegron for the United States and the rest of the world from Merck, Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. in 2017 and subsequently entered into a collaboration agreement with Kyorin later that year. Under the collaboration agreement, Urovant and Kyorin share information related to the development of vibegron, including clinical trial and nonclinical study data. Read more.
Source: The News, October 1, 2018