Myovant Shares Slide Despite Positive Late-Stage Data For Menstrual Bleeding Drug

Myovant Sciences Ltd MYOV shares were trading sharply lower Tuesday despite seemingly positive news on the company's pipeline candidate for menstrual bleeding in women with uterine fibroids.

What Happened

Myovant released topline data from one of the Phase 3 studies, dubbed LIBERTY 1, which evaluated the drug relugolix. The data showed that the study met its primary efficacy endpoint, with 73.4 percent of women receiving the combo therapy achieving a menstrual blood loss volume of less than 80 ml compared to 18.9 percent for placebo.

Relugolix, an oral once-daily small molecule acting as a gonadotropin-releasing hormone, is being tested in a 40mg dose in combination with 1mg estradiol and 0.5mg norethindrone acetate.

Bone mineral density was comparable between the relugolix combo and placebo groups, according to Myovant. 

The study also achieved six key secondary endpoints with statistical significance relative to placebo, the company said. 

The overall incidence of adverse events in the relugolix combo and placebo were comparable at 62 percent vs. 66 percent, respectively. 

Why It's Important

Relugolix is Myovant's lead candidate and is in the most advanced stages of clinical trials among its pipeline assets. It is being tested for three indications — menstrual bleeding, endometriosis-related pain and advanced prostate cancer in men — in five late-stage studies.

The company has competition from Elagolix, which is copromoted by Neurocrine Biosciences, Inc. NBIX and AbbVie Inc ABBV, as well as from OBE2109 from Obseva SA OBSV. Both drugs are in Phase 3 trials.

What's Next

Myovant said it expects topline data from the second Phase 3 study dubbed LIBERTY 2 to be released in the third quarter of 2019. Contingent on the success of the study, the company said it plans to submit an NDA to the FDA in the fourth quarter of 2019.

Myovant shares were slumping 25.46 percent to $12.88 at the time of publication Tuesday — their lowest level in over a year.

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