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Watch Out For Tuesday - Will Myovant's HERO Prove Its Mettle?

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Myovant Sciences Ltd. (MYOV) is slated to present results from its phase III study of once-daily, oral Relugolix in men with advanced prostate cancer on Tuesday, November 19, 2019.

In the 1,100-patient phase III study, dubbed HERO, the benefit and safety of Relugolix 120 mg orally once daily was evaluated against *Leuprolide in participants with androgen-sensitive advanced prostate cancer who require at least 1 year (48 weeks) of continuous androgen deprivation therapy. The primary efficacy outcome of the study is the ability of Relugolix to achieve and maintain serum testosterone suppression to castrate level to more than or equal to 50ng/dL for 48 weeks. (*Leuprolide is an injectable, man-made human gonadotropin-releasing hormone (GnRH) that is used for treating prostate cancer).

Relugolix is also under a phase III clinical program consisting of two international, replicate pivotal clinical studies, dubbed SPIRIT 1 and SPIRIT 2, in women with endometriosis-associated pain, and in a phase III program, consisting of two studies LIBERTY 1 and LIBERTY 2, in women with heavy menstrual bleeding associated with uterine fibroids.

Myovant in-licensed Relugolix from Takeda in 2016 for territories outside of Japan and Asia.

Relugolix is a small molecule, gonadotropin-releasing hormone (GnRH) receptor antagonist. As a GnRH receptor antagonist, Relugolix binds to and blocks the GnRH receptor (GnRHR) in the anterior pituitary gland.

Blocking GnRH receptors decreases the release of gonadotropins - luteinizing hormone (LH) and follicle-stimulating hormone (FSH) - thereby decreasing the downstream production of estrogen and progesterone by the ovaries in women and testosterone by the testes in men.

Relugolix, under brand name Relumina Tablets 40 mg, was approved in Japan early this year for the improvement of symptoms of uterine fibroids (heavy menstrual bleeding, lower abdominal pain, lower back pain, and anemia).

MYOV closed Monday's trading at $6.06, down 1.78%. In after-hours, the stock was up 14.69% to $6.95.

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