Myovant Sciences Ltd (MYOV)

[Cosa]

This is going to boom. They will get approval from FDA. 50-100% Gain coming within a year. Some key notes below. Good luck! Myov

The open-label extension study also met the primary endpoint with relugolix combination therapy demonstrating an 87.7% response rate at one year, showing the durability of the response observed in LIBERTY 1 and 2. In addition, women experienced, on average, an 89.9% reduction in menstrual blood loss from baseline. Changes in bone mineral density through one year, as assessed by DXA every three months, were consistent with LIBERTY 1 and 2. The incidence of adverse events over one year was consistent with that observed in LIBERTY 1 and 2, with no new safety signals observed.

Relugolix combination tablet is under review by the U.S. Food and Drug Administration (FDA) for the treatment of women with uterine fibroids, with a target action date of June 1, 2021. Myovant submitted a Marketing Authorization Application to the European Medicines Agency in March 2020 for relugolix combination tablet in uterine fibroids. Additionally, 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. Myovant has also reported positive data from two replicate Phase 3 studies evaluating relugolix combination therapy in women with endometriosis.