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Myovant Sciences (NYSE: MYOV) announced positive top-line results from the SPIRIT 1 Phase 3 trial of relugolix combination therapy for endometriosis. The therapy met co-primary endpoints with response rates of 74.5% for dysmenorrhea and 58.5% for non-menstrual pelvic pain, significantly outperforming placebo. On average, participants reported a 73.3% reduction in dysmenorrhea pain. Moreover, all seven key secondary endpoints were achieved, demonstrating the therapy's effectiveness. The drug was well-tolerated with minimal adverse effects, and a New Drug Application to the FDA is planned, marking further advancements for Myovant in women's healthcare.
Myovant Sciences (MYOV) announced that the FDA has accepted its New Drug Application for relugolix, an oral treatment for advanced prostate cancer, for Priority Review. The FDA's target action date is December 20, 2020. Relugolix showed superior efficacy in the Phase 3 HERO study, achieving 96.7% testosterone suppression compared to 88.8% for leuprolide acetate, with a 54% lower risk of major adverse cardiovascular events. If approved, relugolix would be the first oral GnRH receptor antagonist for this indication.
Myovant Sciences presented significant results from its Phase 3 HERO study on relugolix, an oral medication for advanced prostate cancer, during the ASCO20 Virtual Scientific Program. The data reveal that relugolix demonstrated superior testosterone suppression compared to leuprolide acetate, with 96.7% achieving sustained levels below 50 ng/dL through 48 weeks. Notably, it also showed a 54% reduced risk of major cardiovascular events. The company aims to accelerate the FDA approval process for relugolix, highlighting its potential to improve quality of life for patients.
Myovant Sciences (MYOV) announced positive results from the Phase 3 SPIRIT 2 study for endometriosis, achieving co-primary and multiple secondary endpoints. The company submitted a New Drug Application (NDA) for relugolix monotherapy for advanced prostate cancer, with results expected in Q3 2020. A Marketing Authorization Application for the relugolix combination tablet for uterine fibroids is also under evaluation in Europe. Myovant reported a net loss of $64.9 million for Q4 2020, a decrease from $75.0 million the previous year, with total resources of $365.9 million as of March 31, 2020.
Myovant Sciences (NYSE: MYOV) announced the presentation of new data from the Phase 3 HERO study for relugolix, an oral treatment for men with advanced prostate cancer, at the ASCO20 Virtual Scientific Program on May 29-31, 2020. Dr. Neal Shore will present findings comparing relugolix to leuprolide acetate, showcasing efficacy and cardiovascular safety. This data supports Myovant's New Drug Application submitted to the FDA in April 2020. Myovant aims to redefine care for men and women with innovative therapies including relugolix for uterine fibroids and endometriosis.