Healthcare company Myovant Sciences Ltd. (MYOV:NYSE) today announced that "it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its once-daily relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for the treatment of women with heavy menstrual bleeding associated with uterine fibroids."
The company' CEO Lynn Seely, M.D., commented, "An estimated five million women in the U.S. suffer from symptoms of uterine fibroids, which may include heavy menstrual bleeding, pain, and anemia—yet effective non-invasive treatment options are very limited...If approved, we hope to redefine care for these women with relugolix combination tablet, a potential new treatment that demonstrated a predictable and clinically-meaningful reduction in menstrual blood loss while maintaining bone health in the Phase 3 LIBERTY program."
The company highlighted in the report that "the NDA is supported by positive data from two Phase 3 studies and a long-term extension study, demonstrating sustained reduction in heavy menstrual bleeding while maintaining bone health through one year, and that if approved, relugolix combination tablet would be the first once-daily, oral treatment for women with heavy menstrual bleeding associated with uterine fibroids in the U.S."
The firm additionally pointed out that this NDA is the third such regulatory application it has submitted this year noting that it filed a Marketing Authorization Application to the European Medicines Agency in uterine fibroids and an NDA in advanced prostate cancer.
The company explained that "uterine fibroids are noncancerous tumors that develop in or on the muscular walls of the uterus and are among the most common reproductive tract tumors in women." The firm noted that around five million women in the U.S. suffer from symptoms of uterine fibroids.
The company listed that "relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces ovarian estradiol production, a hormone known to stimulate the growth of uterine fibroids and endometriosis, and testicular testosterone production, a hormone known to stimulate the growth of prostate cancer."
The company is presently developing a relugolix combination tablet for use by women with uterine fibroids and for women with endometriosis and is also working on a relugolix monotherapy tablet for men with advanced prostate cancer.
Myovant Sciences Ltd. is a clinical-stage biopharmaceutical company focused on developing and commercializing therapies for the treatment of women's health, prostate cancer and endocrine diseases. The company's lead product candidate is relugolix, a once-daily, oral GnRH receptor antagonist that binds to and inhibits receptors in the anterior pituitary gland. The company has three late-stage clinical programs for relugolix in uterine fibroids, endometriosis and prostate cancer.
Myovant Sciences began the day with a market capitalization of around $1.1 billion with approximately 89.87 million shares outstanding and a short interest of about 3.5%. MYOV shares opened higher today at $12.54 (+$0.29, +2.36%) over Friday's $12.25 closing price. The stock has traded today between $12.44 and $19.00 per share and is currently trading at $16.99 (+$4.74, 38.69%).
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