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 was transformational for Urovant. In November, we announced the signing of a definitive merger agreement with Sumitovant Biopharma, the majority shareholder of Urovant. Under the terms of the definitive agreement, Urovant will be acquire by Sumitovant Biopharma at a 96% premium to the closing price of our shares prior to the agreement being announced. We look forward to obtaining sharehold
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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 efficacy, safety, and tolerability of a single administration of URO-902, a novel gene therapy being developed for patients with OAB who have failed oral pharmacologic therapy. URO-902 is administered via direct intradetrusor injections into the bladder wall under local anesthesia in patients who are experiencing OAB symptoms and UUI.
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.”
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.”
Sumitovant Biopharma Announces Myovant Sciences and Pfizer Enter Collaboration to Develop and Commercialize Relugolix in Oncology and Women s Health wboc.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from wboc.com Daily Mail and Mail on Sunday newspapers.
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 (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.