Shares of Myovant Sciences MYOV went up about 14% after SPIRIT 1, the second of the two phase III studies on its pipeline candidate, relugolix, in women with pain associated with endometriosis, met its co-primary endpoints. In the study,the once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) also met all seven key secondary endpoints. Shares of Myovant have surged 28.2% so far this year compared with the industry’s growth of 13.6%.
According to the top-line data, the relugolix combination therapy demonstrated clinically-meaningful pain reductions for 74.5% of women with dysmenorrhea(menstrual pain) and 58.5% of women with non-menstrual pelvic paincompared to 26.9% and 39.6% of women in the placebo group, respectively. The study achieved all seven key secondary endpoints, including dyspareunia (painful intercourse) and a greater proportion of women not using opioids, with a generally well-tolerated safety profile, including minimal bone mineral density loss over 24 weeks.
The results were consistent with the previously announced SPIRIT 2 study.
Women who completed the SPIRIT 1 or SPIRIT 2 studies were offered the opportunity to enroll in an extension study, with one-year results expected in the first quarter of 2021. According to Myovant, these results from the extension study along with data from the SPIRIT 1 and SPIRIT 2 studies will form the basis of a marketing application for relugolix.
Relugolix is also being developed for two other indications to treat women with heavy menstrual bleeding from uterine fibroids as well as men with advanced prostate cancer. The company has filed a new drug application (NDA) to the FDA for the treatment of men with advanced prostate cancer.
Potential approval of relugolix for treating endometriosis, prostate cancer and uterine fibroids will be a significant milestone for Myovant and boost its share price.
The company is 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.
Zacks Rank and Other Stocks to Consider
Myovant is currently a Zacks Rank #2 (Buy) stock.
Some other top-ranked stocks in the biotech sector are AkceaThrapeuticss Inc. AKCA, Emergent Biosolutions Inc. EBS and AytuBioScience Inc. AYTU, all carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Akcea’s loss per share estimates have narrowed from $2.07 to $1.37 for 2020 and from $2.46 to $1.85 for 2021 in the past 60 days.
Emergent’s earnings per share estimates have increased from $3.43 to $4.03 for 2020 and from $3.54 to $3.73 for 2021 in the past 60 days.
Aytu’s loss per share estimates have narrowed from $1.26 to 12 cents for 2020 in the past 60 days.
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