Myovant set to file for approval following solid Ph III data for relugolix
Shares of Myovant Sciences (NYSE: MYOV), a clinical-stage healthcare firm that is part of the Roivant family of companies, leapt 17.8% at $9.61 in pre-market trading after releasing positive results for its uterine fibroids treatment.
The company announced that LIBERTY 2, the second of two Phase III studies of once-daily relugolix combination therapy (relugolix 40mg plus estradiol 1.0mg and norethindrone acetate 0.5mg), met its primary efficacy endpoint and six key secondary endpoints in women with uterine fibroids.
In addition, relugolix combination therapy maintained bone mineral density at levels comparable to placebo over 24 weeks and was generally well-tolerated. These results confirm the previously announced data from the Phase III LIBERTY 1 study and enable a New Drug Application (NDA) submission to the US Food and Drug Administration by the end of this year.
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