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Myovant (MYOV), Pfizer sNDA for Myfembree Accepted by the FDA

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Myovant Sciences (MYOV - Free Report) recently announced that the FDA has accepted for review a supplemental new drug application (sNDA) for Myfembree (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg).

The drug is being jointly developed and commercialized by Myovant and partner Pfizer (PFE - Free Report) in the United States.

The sNDA is seeking approval of the drug for the management of moderate to severe pain associated with endometriosis. The FDA has set a target action date of May 6, 2022.

The sNDA is supported by results from the phase III SPIRIT program. It included two multinational, replicate clinical studies (SPIRIT 1 and SPIRIT 2) in more than 1,200 women with pain associated with endometriosis for 24 weeks, and an open-label extension study for eligible women who completed either SPIRIT 1 or SPIRIT 2 through one year.

We remind investors that the FDA approved Myfembree as the first and only once-daily oral treatment for the management of heavy menstrual bleeding associated with uterine fibroids. It was launched in mid-June 2021.  The approval triggered a $100.0 million regulatory milestone payment from Pfizer, which the company received in July 2021.

Myovant’s shares have declined 9.1% so far this year against the industry’s growth of 1.3%.


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A potential label expansion of the drug will boost the company’s growth.

Earlier, in May, the FDA placed a partial clinical hold on phase III SERENE study evaluating Myfembree for the prevention of pregnancy, pending certain study protocol modifications. In July 2021, Myovant provided an amended study protocol for the SERENE study to the agency.

Myovant has another approved drug in its portfolio, Orgovyx (relugolix), which was approved by the FDA in 2020 as the first and only oral gonadotropin-releasing hormone (GnRH) receptor antagonist for the treatment of adult patients with advanced prostate cancer.

Myfembree is relugolix combination tablet. In July 2021, the European Commission also approved the same under the brand name Ryeqo. 

Zacks Rank & Stocks to Consider

Myovant currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks are Regeneron Corporation (REGN - Free Report) and Moderna (MRNA - Free Report) , currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Earnings estimates for Regeneron have moved up 62 cents for 2021 in the past 60 days.  The stock is up 33.8% year to date.

Earnings estimates for Moderna have moved up 17 cents for 2021 in the past 30 days.  The stock is up 336.4% year to date.