This morning before the U.S. markets opened, healthcare company Myovant Sciences Ltd. (MYOV:NYSE), which is focused on developing innovative treatments for women's health and prostate cancer, announced positive results for its Phase 3 HERO study for oral relugolix. The firm indicated that in the study once-daily, oral relugolix (120 mg) met its primary efficacy endpoint and all six key secondary endpoints in men with advanced prostate cancer and that "these results support a New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) in Q2/20 and future regulatory submissions in Europe and Japan."
The Phase 3 HERO program plans include the enrollment of approximately 1,100 patients. It is a multinational clinical study designed to evaluate the safety and efficacy of relugolix in men with androgen-sensitive advanced prostate cancer who required at least one year of continuous androgen deprivation therapy. The firm states that the trial includes 138 Chinese patients residing in China and Taiwan in order to support future registration in China.
According to Neal Shore, M.D., medical director of the Carolina Urologic Research Center and HERO Program Steering Committee Member, "An oral gonadotropin-releasing hormone, or GnRH, antagonist for advanced prostate cancer has been an aspiration for many years...If approved, relugolix would become the first-of-its-kind oral option for men with advanced prostate cancer."
Lynn Seely, M.D., president and CEO of Myovant Sciences commented, "With the exciting results from the HERO study demonstrating the potential of relugolix to provide unique benefits compared to leuprolide, we look forward to submitting an NDA to the FDA...We are now closer to our goal of bringing a precision oral medicine to the broad spectrum of men with advanced prostate cancer."
The company advises that "prostate cancer is the second most prevalent form of cancer in men and the second leading cause of death due to cancer in men in the U.S. Approximately three million men in the U.S. are currently living with prostate cancer, and approximately 170,000 men are estimated to be newly diagnosed in 2019. Advanced prostate cancer is prostate cancer that has spread or come back after treatment."
The firm explains that Relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces testicular testosterone production, the hormone primarily responsible for stimulating prostate cancer, and ovarian estradiol production, a hormone known to stimulate the growth of uterine fibroids and endometriosis.
Myovant Sciences 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 approximately $543.1 million with about 89.62 million shares outstanding, along with a 4.50% short interest. MYOV shares opened 120% higher today at $13.37 (+$7.31, +120.63%) over yesterday's $6.06 closing price. The stock has traded today between $10.37 to $17.17 per share and closed at $12.92 (+$6.86, +113.20%) on very high volume.
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