Myovant Sciences MYOV announced that it has submitted a new drug application (“NDA”) to the FDA seeking approval for a combination regimen of oral relugolix (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) as a treatment for women with heavy menstrual bleeding associated with uterine fibroids.
The NDA was based on positive data from two phase III studies — LIBERTY 1 & 2 — which evaluated the combination regimen as a treatment for heavy menstrual bleeding associated with uterine fibroids. Data from the studies showed that more than 70% of patients displayed response rate who were treated with relugolix combo regimen, compared to almost or above 15% for placebo. Data from the studies also showed that women receiving treatment with relugolix combo regimen achieved an 84.3% reduction in menstrual blood loss from baseline at week 24, on average.
Myovant had already submitted a regulatory application seeking approval for combination regimen of oral relugolix for uterine fibroids earlier this year.
The company had also filed a NDA in April seeking approval for relugolix (120mg) for the treatment of men with advanced prostate cancer. The regulatory application was filed based on data from a phase III HERO study.
Shares of Myovant have gained 9.1% so far this year compared with the industry’s increase of 9.5%.
The company is also developing relugolix in combination with estradiol and norethindrone acetate for treating endometriosis-associated pain. Top-line data from two phase III studies — SPIRIT 1 & 2 — evaluating the relugolix combo in patients suffering from endometriosis-associated pain are expected in the first half of 2020.
The company is also developing another pipeline candidate, MVT-602, as a potential treatment for female infertility. Notably, Myovant has in-licensed both relugolix and MVT-602 from Takeda TAK.
Potential approval of relugolix for treating prostate cancer and uterine fibroids will be significant milestones for Myovant and will likely boost its share price.
However, we note that there are several drugs approved for prostate cancer and/or uterine fibroids including J&J’s JNJ Erleada and Zytiga, and AbbVie’s ABBV Lupron. Moreover, there are several generic versions of Zytiga available in the market. If approved, Relugolix is likely to face competition from these drugs.
Myovant Sciences Ltd. Price
Myovant Sciences Ltd. price | Myovant Sciences Ltd. Quote
Myovant currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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