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Myovant Sciences and Pfizer announced promising results from the Phase 3 LIBERTY randomized withdrawal study of relugolix combination therapy for uterine fibroids. The study showed that 78.4% of women continuing treatment remained responders through Week 76, compared to 15.1% who discontinued. After 104 weeks, 69.8% remained responders. However, 88.3% of those who stopped treatment relapsed with heavy menstrual bleeding. The therapy maintains bone density and shows consistent safety results. The FDA decision on the treatment is expected by June 1, 2021.
Myovant Sciences (NYSE: MYOV) announced the inaugural recipients of its Forward for Health Equity grants, aimed at improving healthcare access and reducing racial disparities in prostate cancer and uterine fibroids in the U.S. Four nonprofit organizations received up to $50,000 each for innovative projects. Notable recipients include Emmanual Health Education and the University of California, San Francisco for prostate cancer initiatives, and the Center for Black Health & Equity and Boston Medical Center for uterine fibroid projects. This initiative reflects Myovant's commitment to health equity.
Myovant Sciences (NYSE: MYOV) will host webcasts at two upcoming investor conferences. The SVB Leerink 10th Annual Global Healthcare Conference is on February 25, 2021, where CEO David Marek and CFO Frank Karbe will engage in a fireside chat at 3:40 p.m. ET. The Cowen 41st Annual Health Care Conference follows on March 2, 2021, at 11:10 a.m. ET, featuring similar participation from management. Presentations will be available on Myovant's website.
Myovant Sciences (MYOV) and Pfizer published results from the Phase 3 LIBERTY 1 and LIBERTY 2 studies in the New England Journal of Medicine. The investigational relugolix combination therapy showed a 73.4% and 71.2% response rate in menstrual blood loss, with an 84.3% average reduction from baseline. Six out of seven key secondary endpoints, including pain reduction, were achieved. Bone mineral density remained stable compared to placebo. The data is part of the New Drug Application for relugolix for uterine fibroids, with an FDA decision expected by June 1, 2021.
Myovant Sciences (NYSE: MYOV) announced the approval of equity awards for 7 new employees, granting a total of 30,000 restricted stock units (RSUs) effective February 16, 2021. The RSUs will vest incrementally, with 25% vesting on the one-year anniversary and the remainder vesting quarterly based on continued employment. This offering aligns with Myovant's 2020 Inducement Plan and adheres to NYSE regulations. The company focuses on innovative treatments for men's and women's health, including its FDA-approved drug ORGOVYX™ for advanced prostate cancer.
Myovant Sciences (NYSE: MYOV) and HealthyWomen have launched the "Voices of Periods" initiative, aiming to address menstrual health stigma through personal storytelling. Six women share their experiences in a new video series, explored through a workshop with The Moth. The initiative emphasizes the importance of listening to women's narratives and encourages wider conversation around menstruation. Myovant's CEO, David Marek, highlights the goal of breaking the silence on this topic. More information and video stories can be found at femaleforwardtogether.com.
Myovant Sciences (MYOV) reported financial results for Q3 FY2020, highlighting the FDA's approval of ORGOVYX™ as the first oral GnRH receptor antagonist for advanced prostate cancer and its collaboration with Pfizer, which includes a $650 million upfront payment. Cash and equivalents totaled $745.8 million as of December 31, 2020. The company aims for a June 1, 2021 FDA decision on the relugolix combination tablet for uterine fibroids. Despite a net loss of $73.8 million, there are positive indicators from ongoing clinical studies and commercial readiness for product launches.
Myovant Sciences (NYSE: MYOV) announced a webcast and conference call on February 11, 2021, at 8:30 a.m. ET, to discuss its Q3 2020 financial results for the period ending December 31, 2020. Investors can access the live event via Myovant’s investor relations page. The company currently has one FDA-approved medicine, ORGOVYX™, and is awaiting regulatory review for its lead product candidate for uterine fibroids. Myovant aims to redefine care for men and women with innovative treatments.
Myovant Sciences and Pfizer announced positive results from the Phase 3 SPIRIT long-term study of relugolix combination therapy for endometriosis, showing 84.8% and 73.3% of participants achieving significant reductions in dysmenorrhea and non-menstrual pelvic pain respectively over one year. The average pain score dropped from 7.4 to 1.3, indicating an 82.8% reduction. Minimal bone mineral density loss was noted. A New Drug Application to the FDA is expected in the first half of 2021.
Myovant Sciences (NYSE: MYOV) announced equity awards for its newly appointed CEO, David Marek, consisting of 223,076 restricted stock units (RSUs) and an option to purchase 306,427 common shares. Additionally, RSUs for 87,300 shares were granted to eight other employees. The awards, effective January 15, 2021, will vest in installments over several years, contingent on continued employment. The option's exercise price is set at $20.54, reflecting the closing price on the grant date. Myovant focuses on innovative treatments for women's and men's health, including advanced prostate cancer and uterine fibroids.