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Myovant's Drug To Treat Uterine Fibroids Hits Key Goals In Phase III Study

(RTTNews) - Myovant Sciences' (MYOV) phase III study of once daily Relugolix combination therapy met its primary and key secondary goals in women with uterine fibroids and heavy menstrual bleeding.

The study, dubbed LIBERTY 1, achieved the primary efficacy endpoint demonstrating highly statistically significant 73.4% response rate, with women experiencing, on average, an 84.3% reduction in menstrual blood loss.

Relugolix combination therapy also maintained bone mineral density at levels comparable to placebo over 24 weeks and was generally well tolerated, according to the Company.

The six key secondary endpoints including mean change in menstrual blood loss from baseline to week 24, reduction in pain in women with pain at baseline, improvement in quality of life, amenorrhea defined as no or negligible blood loss, improvement in anemia in those women with anemia at baseline, and reduction in uterine volume were also achieved with statistical significance compared to placebo.

Another phase III study of once daily Relugolix combination therapy in women with uterine fibroids and heavy menstrual bleeding, dubbed LIBERTY 2, is underway, with data expected in the third quarter of 2019.

If all goes well as planned, the Company plans to submit a New Drug Application for Relugolix to the FDA in the fourth quarter of 2019.

MYOV has traded in a range of $14.32 to $27.45 in the last 1 year. In pre-market trading on Tuesday, the stock is up 0.75% to $17.35.

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