Page 3 - Spirovant Sciences News Today

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Urovant Sciences Announces Publication of Positive Long-Term Clinical Safety and Efficacy Data on the FDA-Approved Overactive Bladder Therapy, GEMTESA (vibegron), in the Journal of Urology Urovant Sciences, a wholly owned subsidiary of Sumitovant, announced today that the Journal of Urology has published positive safety and efficacy data from the GEMTESA (vibegron) double-blind 40-week extension study with patient data over a total exposure of 52 weeks (NCT03583372) in the print version of the...

Sumitovant Biopharma Announces Publication in the New England Journal of Medicine of Myovant Sciences Phase 3 LIBERTY Studies of Once-Daily Relugolix Combination Therapy in Women with Uterine Fibroids •LIBERTY 1 and LIBERTY 2 achieved 73.4% and 71.2% response rates in menstrual blood loss, with an average reduction of 84.3% from baseline •Achieved six of seven key secondary endpoints including reduction of pain •Bone mineral density maintained at levels comparable to pl...

Press release content from Globe Newswire. The AP news staff was not involved in its creation. Sumitovant Biopharma Announces Publication in the New England Journal of Medicine of Myovant ... Sumitovant BiopharmaFebruary 18, 2021 GMT New York, London, Feb. 17, 2021 (GLOBE NEWSWIRE) -- Sumitovant Biopharma Ltd., a majority shareholder of Myovant Sciences (NYSE: MYOV), announced today that the New England Journal of Medicine published Myovant Sciences’ Phase 3 LIBERTY 1 and LIBERTY 2 studies of...

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 ...

(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. ...

Press release content from Globe Newswire. The AP news staff was not involved in its creation. UPDATE - Sumitovant Biopharma Announces Myovant Sciences and Pfizer Enter Collaboration to ... Sumitovant BiopharmaDecember 28, 2020 GMT Myrtle Potter, CEO Sumitovant Biopharma “By forming a transformative collaboration with Myovant Sciences and Pfizer, we have taken steps to help position ORGOVYX for advanced prostate cancer and relugolix once-daily combination for Women’s Health for success.” ...

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®...

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 medi...

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) wit...