RTTNews | Aug 17, 2020 10:10AM EDT

10:09 Monday, August 17, 2020 (RTTNews.com) - Shares of Myovant Sciences Ltd. (MYOV) are rising over 7% Monday morning, after the company announced that its New Drug Application or NDA for once-daily, oral relugolix combination tablet for the treatment of women with heavy menstrual bleeding associated with uterine fibroids has been accepted for review by the U.S. FDA.

The stock has been trading in the range of $4.14 - $22.07 for the past one year, and is currently trading at $18.09, up $1.19 or 7.04%.

The company noted that the FDA has set a target action date of June 1, 2021 under the Prescription Drug User Fee Act or PDUFA. In its acceptance letter, the FDA also stated that it is currently not planning to hold an advisory committee meeting for this application.

Relugolix (120 mg) is under Priority Review by the FDA for the treatment of men with advanced prostate cancer, with a target action date of December 20, 2020. Additionally, Myovant submitted a Marketing Authorization Application to the European Medicines Agency in March 2020 for relugolix combination tablet for the treatment of women with uterine fibroids. Myovant has also reported positive data from two replicate Phase 3 studies evaluating relugolix combination therapy in women with endometriosis.

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