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Myovant (MYOV), Pfizer Start Dosing in Relugolix Combo Study

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Myovant Sciences (MYOV - Free Report) and partner Pfizer Inc. (PFE - Free Report) announced that the first participant has been dosed in the late-stage study evaluating the contraceptive efficacy of the relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg).

The phase III SERENE study will enroll 900 sexually active, healthy women aged 18-35 years with presumed normal fertility. The primary efficacy endpoint is the at-risk Pearl Index, defined as the number of on-treatment pregnancies (pregnancies with an estimated conception date between the first day of study intervention intake up to and including seven days after the last intake of study medication) per 100 women-years of treatment.  The study will also collect the safety data.

The contraceptive potential of the relugolix combination tablet was supported by a prior phase I study that demonstrated 100% ovulation inhibition.

Positive data from the SERENE study will complement data from the previous phase III LIBERTY and SPIRIT programs, which demonstrated the promise of the relugolix combination therapy as a potential treatment for uterine fibroids and endometriosis.

Please note that the relugolix combination tablet is under review by the FDA for the treatment of women with uterine fibroids. The agency has set a target action date of Jun 1, 2021. It is also under review in Europe for this indication. A new drug application for the relugolix combination therapy to treat endometriosis in women is expected to be filed in the first half of 2021.

Myovant’s shares have plunged 37.9% so far this year compared with the industry’s decline of 7%.

We remind investors that, in December 2020, the FDA approved Orgovyx (relugolix) for the treatment of adult patients 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.

In the same month, Myovant signed a collaboration and license agreement with Pfizer to jointly develop and commercialize relugolix in oncology and women’s health in the United States and Canada.

The successful development and commercialization of the relugolix combination tablet will be a big boost for the company.

Myovant is also developing MVT-602, an oligopeptide kisspeptin-1 receptor agonist, which has completed a phase IIa study on female infertility as part of assisted reproduction.

It currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the biotech sector include Repligen (RGEN - Free Report) and Moderna, Inc. (MRNA - Free Report) . While Repligen sports a Zacks Rank #1 (Strong Buy), Moderna carries a Zacks Rank #2 (Buy), at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Repligen’s earnings estimates for 2021 have increased to $1.91 from $1.66 in the past 60 days.

Moderna’s earnings estimates for 2021 have increased to $22.72 from $12.72 in the past 60 days.

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