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Urovant Sciences Provides Merger Update and Reports Third Quarter Fiscal Year 2020 Results SEC reviewing preliminary proxy statement for the previously announced merger of the Company with Sumitovant Biopharma Special General Meeting of Shareholders to approve the merger is expected to occur by the end of 1Q CY2021 U.S. commercial launch of GEMTESA (vibegron) to treat OAB is on track for late-Q1 CY2021, following U.S. FDA approval in December 2020 Urovant Sciences (Nasdaq: UROV) today reported financial results for its fiscal quarter ended December 31, 2020. "The third quarter of fiscal 2020 ...

(1) Urovant Sciences (Nasdaq: UROV) announced today that the independent Data and Safety Monitoring Board (DSMB) has recommended the continuation of the phase 2a study of URO-902, a novel gene therapy product, in patients with overactive bladder (OAB) and urge urinary incontinence (UUI). URO-902 has the potential to be the first gene therapy for patients with OAB. Following the recommendation of the DSMB, Urovant is proceeding with opening cohort 2 of the study with a dose of 48 mg or placebo. About the Phase 2a Study This randomized, double blind, placebo-controlled study will evaluate the ...

Press release content from Business Wire. The AP news staff was not involved in its creation. Urovant Sciences Announces U.S. FDA Approval of GEMTESA® (vibegron) 75 mg Tablets for the Treatment of Patients with Overactive Bladder (OAB) December 23, 2020 GMT IRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Dec 23, 2020-- Urovant Sciences (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 (OA...

Posted on 16366 Urovant Sciences (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. This approval marks the first new oral branded OAB medication approved by the FDA since 2012, and it is the first product approval for Urovant Sciences. â€...

Dec 23, 2020 21:05 UTC Urovant Sciences Announces U.S. FDA Approval of GEMTESA® (vibegron) 75 mg Tablets for the Treatment of Patients with Overactive Bladder (OAB) IRVINE, Calif. & BASEL, Switzerland--(Business Wire)--Urovant Sciences (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. This approv...