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FDA Finds Deficiencies in Myovant (MYOV), Pfizer's Myfembree sNDA
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Myovant Sciences announced that it received a notice from the FDA last week, which identifies deficiencies that preclude decision on labelling and/or post-marketing requirements in MYOV’s supplemental new drug application (sNDA) for Myfembree.
This sNDA, accepted by the FDA in October 2021, seeks approval for Myfembree (relugolix 40 mg, estradiol 1 mg and norethindrone acetate 0.5 mg) to manage moderate to severe pain associated with endometriosis. Though the notice does not provide any additional information on the deficiencies, the regulatory agency continues to review Myovant’s sNDA and is yet to communicate its final decision. At the time of accepting the sNDA, the FDA had set a target action date of May 6, 2022.
Shares of Myovant fell more than 20% in pre-market trading on Apr 12 following the news. The stock has declined 10.9% so far this year compared with the industry’s 13.9% decrease.
Image Source: Zacks Investment Research
The sNDA, accepted by the FDA, was supported by results from the phase III SPIRIT program. Data from the program demonstrated a clinically meaningful reduction in dysmenorrhea (menstrual pain) and non-menstrual pelvic pain in participants who were administered the drug.
Myfembree received its first FDA approval in May 2021 for the management of heavy menstrual bleeding associated with uterine fibroids. The drug is also approved in Europe for a similar indication and marketed under the trade name Ryeqo. MYOV anticipates submitting a regulatory application in Europe, seeking label expansion of Ryeqo for endometriosis-associated pain later this year.
Myfembree is part of a collaboration agreement with Pfizer (PFE - Free Report) . The deal was formalized in December 2020 to jointly develop and commercialize relugolix for oncology and women’s health in the United States and Canada.
Per the agreement terms, Myovant will be responsible for all the clinical development and regulatory interactions plus record the entire drug sales. However, MYOV will share profits and certain expenses equally with Pfizer. In return, the former will be eligible to receive milestone payments from PFE.
Myovant received $650 million as an upfront payment in December 2020 at the time of signing the agreement. The initial approval for Myfembree to address menstrual breeding resulted in a $100-million regulatory milestone fee from Pfizer, which MYOV received in July 2021.
If Myfembree was approved for endometriosis, it could fetch another $100-million regulatory milestone payment from Pfizer. Such label expansions will not only boost Myovant’s’s growth but also provide it with cash to support its pipeline development and operations.
Apart from Myfembree, Myovant has Orgovyx (relugolix) in its portfolio, approved by the FDA in 2020 as the first and the only oral gonadotropin-releasing hormone (GnRH) receptor antagonist for the treatment of adult patients with advanced prostate cancer.
Angion Biomedica’s loss per share estimates for 2022 have narrowed from $2.52 to $1.92 in the past 60 days. The same for 2023 has narrowed from $3.11 to $2.19 in the past 60 days.
Earnings of Angion Biomedica beat estimates in three of the last four quarters and missed the mark in one, the average surprise being 47.5%.
Collegium Pharmaceutical’s earnings per share estimates for 2022 have increased from $3.79 to $5.59 in the past 60 days. The same for 2023 has increased from $4.79 to $7.44 in the past 60 days. Shares of COLL have risen 5.3% year to date.
Earnings of Collegium Pharmaceutical missed estimates in three of the last four quarters and beat the mark on one occasion, the negative surprise being 57.6%, on average.
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FDA Finds Deficiencies in Myovant (MYOV), Pfizer's Myfembree sNDA
Myovant Sciences announced that it received a notice from the FDA last week, which identifies deficiencies that preclude decision on labelling and/or post-marketing requirements in MYOV’s supplemental new drug application (sNDA) for Myfembree.
This sNDA, accepted by the FDA in October 2021, seeks approval for Myfembree (relugolix 40 mg, estradiol 1 mg and norethindrone acetate 0.5 mg) to manage moderate to severe pain associated with endometriosis. Though the notice does not provide any additional information on the deficiencies, the regulatory agency continues to review Myovant’s sNDA and is yet to communicate its final decision. At the time of accepting the sNDA, the FDA had set a target action date of May 6, 2022.
Shares of Myovant fell more than 20% in pre-market trading on Apr 12 following the news. The stock has declined 10.9% so far this year compared with the industry’s 13.9% decrease.
Image Source: Zacks Investment Research
The sNDA, accepted by the FDA, was supported by results from the phase III SPIRIT program. Data from the program demonstrated a clinically meaningful reduction in dysmenorrhea (menstrual pain) and non-menstrual pelvic pain in participants who were administered the drug.
Myfembree received its first FDA approval in May 2021 for the management of heavy menstrual bleeding associated with uterine fibroids. The drug is also approved in Europe for a similar indication and marketed under the trade name Ryeqo. MYOV anticipates submitting a regulatory application in Europe, seeking label expansion of Ryeqo for endometriosis-associated pain later this year.
Myfembree is part of a collaboration agreement with Pfizer (PFE - Free Report) . The deal was formalized in December 2020 to jointly develop and commercialize relugolix for oncology and women’s health in the United States and Canada.
Per the agreement terms, Myovant will be responsible for all the clinical development and regulatory interactions plus record the entire drug sales. However, MYOV will share profits and certain expenses equally with Pfizer. In return, the former will be eligible to receive milestone payments from PFE.
Myovant received $650 million as an upfront payment in December 2020 at the time of signing the agreement. The initial approval for Myfembree to address menstrual breeding resulted in a $100-million regulatory milestone fee from Pfizer, which MYOV received in July 2021.
If Myfembree was approved for endometriosis, it could fetch another $100-million regulatory milestone payment from Pfizer. Such label expansions will not only boost Myovant’s’s growth but also provide it with cash to support its pipeline development and operations.
Apart from Myfembree, Myovant has Orgovyx (relugolix) in its portfolio, approved by the FDA in 2020 as the first and the only oral gonadotropin-releasing hormone (GnRH) receptor antagonist for the treatment of adult patients with advanced prostate cancer.
Zacks Rank & Key Picks
Myovant presently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the overall healthcare sector are Angion Biomedica and Collegium Pharmaceutical (COLL - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Angion Biomedica’s loss per share estimates for 2022 have narrowed from $2.52 to $1.92 in the past 60 days. The same for 2023 has narrowed from $3.11 to $2.19 in the past 60 days.
Earnings of Angion Biomedica beat estimates in three of the last four quarters and missed the mark in one, the average surprise being 47.5%.
Collegium Pharmaceutical’s earnings per share estimates for 2022 have increased from $3.79 to $5.59 in the past 60 days. The same for 2023 has increased from $4.79 to $7.44 in the past 60 days. Shares of COLL have risen 5.3% year to date.
Earnings of Collegium Pharmaceutical missed estimates in three of the last four quarters and beat the mark on one occasion, the negative surprise being 57.6%, on average.