Myovant Sciences Ltd. ( MYOV Quick Quote MYOV - Free Report) , along with partner Pfizer ( PFE Quick Quote PFE - Free Report) , announced positive data from a late-stage study evaluating relugolix combination therapy (relugolix 40 mg plus estradiol 1 mg and norethindrone acetate 0.5 mg) for the treatment of uterine fibroids in women.
The phase III LIBERTY randomized withdrawal study assessed the safety and efficacy of continued treatment with relugolix combination therapy for up to two years in the given patient population.
Data from the above-mentioned study shows that 78.4% of women who continued treatment with the relugolix combination therapy achieved the sustained responder rate through week 76 as compared to 15.1% of women who discontinued relugolix combination therapy and initiated placebo – the primary endpoint on the study.
The study also achieved all three key secondary endpoints– sustained responder rate at two years, time to relapse of heavy menstrual bleeding and amenorrhea rate. Moreover, 69.8% of women who continued treatment with relugolix combination therapy remained responders through week 104, while 88.3% of women who discontinued treatment relapsed with heavy menstrual bleeding.
Shares of Myovant were down 6.8% on Wednesday despite the positive announcement. In fact, the stock has plunged 21% so far this year compared with the
industry’s decrease of 0.6%. Please note that relugolix combination therapy is currently under review in the United States for the treatment of uterine fibroids in women. A decision from the FDA is expected by Jun 1, 2021. Relugolix combination therapy is also under regulatory review in Europe for the given indication.
We remind investors that, in December 2020, the FDA approved Orgovyx (relugolix) as monotherapy for the treatment of men with advanced prostate cancer. Following the nod, the drug became the first and only oral GnRH receptor antagonist to be approved by the FDA for the given indication.
The company plans to file a marketing authorization application for use of relugolix monotherapy for advanced prostate cancer in Europe in the first quarter of 2021.
Also, in December 2020, Myovant
signed a collaboration agreement with Pfizer for the development and commercialization of Orgovyx. The companies also decided to jointly develop and commercialize Myovant’s relugolix combination tablet for uterine fibroids and endometriosis.
Notably, in January 2021, the companies announced positive one-year safety and efficacy data from the phase III SPIRIT long-term extension study on relugolix combination therapy in women with endometriosis. A new drug application for relugolix combination therapy to treat endometriosis in women is expected to be filed in the first half of 2021.
Zacks Rank & Stocks to Consider
Myovant currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include
Nabriva Therapeutics AG ( NBRV Quick Quote NBRV - Free Report) and Repligen Corporation ( RGEN Quick Quote RGEN - Free Report) , both carrying a Zacks Rank #2 (Buy) at present. You can see . the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
Nabriva Therapeutics’ loss per share estimates have narrowed 34.3% for 2021 and 44.7% for 2022 over the past 60 days.
Repligen’s earnings estimates have been revised 15.1% upward for 2021 and 9.8% for 2022 over the past 60 days.
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