Myovant Sciences has filed an S-1 form with the U.S. Securities and Exchange Commission (SEC) for its initial public offering (IPO). No pricing details were given in the filing, but the offering is valued up to $172.5 million. The company intends to list its shares on the New York Stock Exchange under the symbol MYOV.

The underwriters for this offering are Citigroup, Cowen, Evercore ISI and Barclays.

This is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for women’s health diseases and other endocrine-related disorders. Its lead product candidate is relugolix, an oral, once-daily, small molecule that acts as a gonadotropin-releasing hormone (GnRH) receptor antagonist. The company is advancing relugolix for the treatment of heavy menstrual bleeding associated with uterine fibroids, endometriosis-associated pain and advanced prostate cancer.

Relugolix has been evaluated in over 1,300 subjects to date, in Phase 1 and multiple large, randomized Phase 2 clinical trials, some of which are ongoing. These trials have produced favorable results in each indication. In these trials, relugolix was shown to be generally well tolerated and to successfully suppress estrogen and progesterone levels in women and testosterone levels in men. The suppression of estrogen and progesterone levels in women has been shown to effectively treat the symptoms of uterine fibroids and endometriosis, and the suppression of testosterone levels in men has been shown to effectively treat advanced prostate cancer.

In a double-blind, placebo-controlled Phase 2 clinical, relugolix posted results that were statistically significant for each treatment arm versus the placebo. Essentially, relugolix markedly decreased menstrual blood loss associated with uterine fibroids.

In two randomized Phase 2 clinical trials in 228 men with advanced prostate cancer, relugolix demonstrated an ability to decrease testosterone to very low levels and to reduce levels of prostate-specific antigen, a key prostate cancer biomarker. These results for relugolix were consistent with those for leuprolide acetate, or leuprolide, a GnRH agonist typically used in androgen deprivation therapy, or ADT, and for degarelix, an injectable GnRH antagonist.

The company intends to use the net proceeds from this offering to further fund its late stage trials of relugolix for multiple indications. The remainder will be used for working capital and general corporate purposes, which may include research and development of relugolix and RVT-602 for other indications.

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