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Myovant Sciences (MYOV) announced a webcast and conference call to discuss its corporate updates and financial results for Q1, ending June 30, 2022. The event is scheduled for July 27, 2022, at 5:00 p.m. ET. Investors can access the live webcast via the company's investor relations page. Myovant has successfully completed five Phase 3 clinical trials, leading to two FDA approvals for treatments related to advanced prostate cancer and heavy menstrual bleeding. The company is also pursuing supplemental New Drug Applications for endometriosis and is developing an investigational treatment for female infertility.
Urovant Sciences has been recognized as one of the Best Places to Work for the second consecutive year by the Orange County Business Journal. This accolade, based on employee feedback, highlights the company's people-focused culture and commitment to enhancing urologic care. Additionally, Urovant received the Great Place to Work certification in 2022, further underscoring its workplace excellence. Urovant’s CEO, James Robinson, expressed pride in these recognitions, emphasizing the company's values of integrity and innovation.
Urovant Sciences has partnered with Pierre Fabre Médicament SAS to register and commercialize vibegron for treating Overactive Bladder (OAB) in the European Economic Area, including the UK and Switzerland. The agreement entitles Urovant to potential payments up to USD 75 million linked to regulatory and sales milestones, as well as royalties based on sales. Urovant retains U.S. commercialization rights. Both companies will also collaborate on clinical trials for pediatric populations in Europe. This partnership enhances Urovant's market reach and aims to improve patient access to effective OAB treatments.
Myovant Sciences and Pfizer announced positive results from their Phase 3 SPIRIT 1 and SPIRIT 2 studies on relugolix combination therapy for endometriosis pain. Over 1,200 women participated, achieving significant reductions in dysmenorrhea and non-menstrual pelvic pain. In the relugolix group, 75% reported meaningful dysmenorrhea reduction compared to 27% in placebo. Safety was acceptable with minimal bone density loss (<1%). The results were published in The Lancet and support a supplemental New Drug Application for MYFEMBREE with a PDUFA action date set for August 6, 2022.
Myovant Sciences (NYSE: MYOV) announced the approval of equity awards for 23 new employees on June 15, 2022, under its 2020 Inducement Plan. The total award comprises 231,800 restricted stock units (RSUs) that will vest over four years, contingent upon continued employment. Myovant seeks to enhance its workforce as it focuses on redefining care in women's and men's health, backed by successful Phase 3 trials and regulatory approvals in the U.S. and Europe for its treatments.
Better Therapeutics (NASDAQ: BTTX) has announced the appointment of Frank Karbe as President and CEO starting July 5, 2022. He replaces co-founder Kevin Appelbaum, who will continue until then. Karbe brings extensive experience, having previously raised approximately $2 billion at Myovant Sciences and over $4 billion at Exelixis. The company is poised for a potential FDA submission of its first digital therapeutic for type 2 diabetes, supported by positive trial data indicating significant improvements in patient outcomes.
Myovant Sciences (NYSE: MYOV) announced that CEO David Marek and CFO Uneek Mehra will participate in a fireside chat at the Goldman Sachs 43rd Annual Global Healthcare Conference on June 16, 2022, at 11:00 a.m. Eastern Time. This event aims to provide insights into Myovant's mission to redefine care for both women and men through innovative science and advocacy. The chat will be available for the public to listen via the Myovant website.
Myovant has received FDA and EC approvals for treatments related to prostate cancer and uterine fibroids and is advancing several clinical trials.
Myovant Sciences (NYSE: MYOV) and Pfizer Inc. (NYSE: PFE) announced that the FDA accepted a supplemental New Drug Application (sNDA) for MYFEMBREE (relugolix, estradiol, norethindrone acetate). This sNDA aims to update the product's prescribing information based on data from the Phase 3 LIBERTY study involving premenopausal women with heavy menstrual bleeding due to uterine fibroids. The FDA's target action date for this review is January 29, 2023. Results showed 78.4% of women on MYFEMBREE maintained a sustained responder rate through Week 76, indicating effective long-term treatment.
Spirovant Sciences has inaugurated a new research laboratory and corporate headquarters in Philadelphia to enhance its development of gene therapies for respiratory diseases, particularly cystic fibrosis. The state-of-the-art facility aims to accelerate the production of their lead programs and expand their therapeutic pipeline. With support from the Science Center and located in the vibrant uCity Square district, this expansion reinforces Spirovant's commitment to biotech innovation and growth in the life sciences sector of Philadelphia.
