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Myovant Sciences and Pfizer have shared new clinical data on relugolix combination therapy at the ASRM 2021 Congress. The therapy targets uterine fibroids and endometriosis pain, showcasing critical efficacy and safety insights from the Phase 3 LIBERTY studies, including a 2-year efficacy profile. Presentations included adverse event analyses and bone mineral density impacts. Currently, MYFEMBREE is FDA-approved for managing heavy menstrual bleeding from uterine fibroids, with ongoing investigations for endometriosis pain, aiming for FDA review by May 2022.
Urovant Sciences has announced key executive appointments aimed at enhancing its operational effectiveness and market presence. Laura Genatossio is appointed as Senior Vice President and General Manager for Europe, bringing extensive global biopharmaceutical experience. Alana Darden Powell is promoted to Vice President of Corporate Communications, and Mark Niemaszek to Senior Vice President of Corporate Planning. Additionally, Ted Chan is promoted to oversee Intellectual Property. These strategic appointments reflect Urovant's growth ambitions in the competitive biopharmaceutical market.
Myovant Sciences (NYSE: MYOV) announced a webcast and conference call on October 26, 2021, at 8:30 a.m. ET to discuss its corporate updates and second fiscal quarter financial results for the period ending September 30, 2021. Investors can access the live webcast on Myovant's investor relations website. The company has two FDA-approved products: ORGOVYX for advanced prostate cancer and MYFEMBREE for heavy menstrual bleeding. A supplemental New Drug Application for endometriosis management is currently under FDA review.
Urovant Sciences presented new data on GEMTESA (vibegron) at the 2021 AUA Annual Meeting, confirming its safety and efficacy for treating overactive bladder (OAB). The ambulatory blood pressure study revealed no significant effects on blood pressure or heart rate. Additionally, Phase 3 EMPOWUR trial analyses indicated that once-daily GEMTESA significantly reduced daily urgency episodes and urinary frequency in patients with OAB, both with and without urge incontinence. These findings support GEMTESA's profile as a treatment option for OAB symptoms.
Myovant Sciences announced that the FDA has accepted its supplemental New Drug Application (sNDA) for MYFEMBREE to treat moderate to severe pain from endometriosis, with a target action date of May 6, 2022. The application is based on positive outcomes from the Phase 3 SPIRIT program involving over 1,200 women. MYFEMBREE is currently approved for managing heavy menstrual bleeding associated with uterine fibroids. If approved, it could significantly improve care options for women suffering from endometriosis.
Urovant Sciences announces its participation in the 2021 Annual Meeting of the American Urological Association (AUA2021), scheduled for September 10-13. Key data on GEMTESA® (vibegron) will be presented virtually, focusing on its effects on ambulatory blood pressure and efficacy in patients with ‘dry’ overactive bladder. Cornelia Haag-Molkenteller stated GEMTESA meets the needs of the approximately 30 million Americans suffering from overactive bladder symptoms. The presentations will feature new clinical trial data supporting GEMTESA's unique safety and efficacy profile.
Myovant Sciences (NYSE: MYOV) will participate in the 2021 Baird Global Healthcare Conference on September 15, 2021. Company management will host a fireside chat at 2:35 p.m. Eastern Time and engage in small group investor meetings. The fireside chat will be available for the public to listen to on the Events page of the Myovant website. Established in 2016, Myovant focuses on innovative care solutions for both women and men, with FDA-approved products like ORGOVYX and MYFEMBREE.
Myovant Sciences has appointed Uneek Mehra as Chief Financial and Business Officer, effective September 7, 2021, succeeding Frank Karbe, who will assist in the transition. Mehra brings over 25 years of experience in finance, corporate strategy, and business development, with a history of growing commercial-stage businesses. His expertise is expected to enhance Myovant's growth as the company advances its FDA-approved therapies, ORGOVYX and MYFEMBREE. Mehra aims to support the company's transition to a rapid-growth commercial organization, pursuing innovative therapies for women's and men's health.
Myovant Sciences reported total revenues of $41.1 million for Q1 2021, up from $33.3 million in Q1 2020. Key product revenues include $10.5 million from ORGOVYX® and $1.1 million from MYFEMBREE®. The FDA approved MYFEMBREE® in May, leading to a $100 million milestone payment from Pfizer. RYEQO® was approved in Europe, generating a $15 million milestone payment. However, the company faced a net loss of $61.7 million, greater than last year's $32.9 million. As of June 30, 2021, Myovant had $611.1 million in capital resources.
Myovant Sciences (MYOV) announced that the European Commission approved RYEQO® (relugolix) for treating moderate to severe uterine fibroid symptoms in women of reproductive age. This is the first once-daily long-term treatment in Europe, with no limitations on usage duration based on Phase 3 LIBERTY program data. Myovant will receive regulatory milestone payments and tiered royalties on sales from their partner, Gedeon Richter, who will commercialize the drug in Europe starting in the second half of 2021. Additionally, a marketing authorization for endometriosis-associated pain is planned for submission this year.
