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Sumitovant Biopharma Announces Publication in the New England Journal of Medicine of Myovant ...

Press release content from Globe Newswire. The AP news staff was not involved in its creation.
Sumitovant Biopharma Announces Publication in the New England Journal of Medicine of Myovant .
Sumitovant BiopharmaFebruary 18, 2021 GMT
New York, London, Feb. 17, 2021 (GLOBE NEWSWIRE) Sumitovant Biopharma Ltd., a majority shareholder of Myovant Sciences (NYSE: MYOV), announced today that the New England Journal of Medicine published Myovant Sciences’ Phase 3 LIBERTY 1 and LIBERTY 2 studies of investigational once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with uterine fibroids. As previously reported, both studies achieved the primary endpoint of response rates in menstrual blood loss in addition to six of the seven key secondary endpoints, while maintaining bone mineral density comparable to placebo as part of a well-tolerated safety profile over 24 weeks. ....

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Myovant Sciences and Pfizer Announce Publication in the New England Journal of Medicine of Phase 3 LIBERTY Studies of Once-Daily Relugolix Combination Therapy in Women with Uterine Fibroids

Myovant Sciences and Pfizer Announce Publication in the New England Journal of Medicine of Phase 3 LIBERTY Studies of Once-Daily Relugolix Combination Therapy in Women with Uterine Fibroids
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Myovant Sciences Announces Corporate Updates and Financial Results for Third Quarter of Fiscal ...

Press release content from Globe Newswire. The AP news staff was not involved in its creation.
Myovant Sciences Announces Corporate Updates and Financial Results for Third Quarter of Fiscal .
Myovant Sciences, Inc.February 11, 2021 GMT
ORGOVYX™ (relugolix) approved by the
U.S. Food and Drug Administration (FDA) in December 2020 as the first and only oral GnRH receptor antagonist for adult patients with advanced prostate cancer; ORGOVYX launched in the U.S. in early January 2021
Announced collaboration with Pfizer in December 2020 to jointly develop and commercialize relugolix in oncology and relugolix combination tablet in women’s health in the U.S. and Canada ....

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Myovant Sciences and Pfizer Announce Positive One-Year Data from Phase 3 SPIRIT Extension Study of Once-Daily Relugolix Combination Therapy in Women with Endometriosis

Published: Jan 26, 2021
84.8% and 73.3% of women reported clinically meaningful reductions in dysmenorrhea (menstrual pain) and non-menstrual pelvic pain at one year
82.8% average reduction from baseline
on the Numerical Rating Scale for dysmenorrhea from 7.4 (severe pain) to 1.3 (mild pain)
over one year
Bone mineral density loss was minimal at Week 24 and remained stable through one year
Data to be included in New Drug Application submission to U.S. Food and Drug Administration anticipated in first half of 2021
BASEL, Switzerland and NEW YORK, Jan. 26, 2021 (GLOBE NEWSWIRE) Myovant Sciences (NYSE: MYOV) and Pfizer Inc.. (NYSE: PFE) today announced that the Phase 3 SPIRIT long-term extension study of the investigational once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with endometriosis reported clinically meaningful reductions in dysmenorrhea (menstrual pain) and non-m ....

United States , San Francisco , Albert Liao , Bryan Crowe , Steve Danehy , James Rusnak , Chuck Triano , Linda Giudice , Juan Camilo Arjona Ferreira , University Of California , Program Steering Committee Member , Reproductive Sciences , Global Product Development At Pfizer , Pfizer Inc , Virtual Congress , Myovant Sciences Forward , American Society For Reproductive Medicine , Myovant Sciences , Drug Administration , Exchange Commission , Myovant Sciences Contacts , Myovant Sciences Inc , Sumitomo Dainippon Pharma Co Ltd , Sumitovant Biopharma Ltd , Program In Endometriosis , Numerical Rating Scale ,

UPDATE: Sumitovant Biopharma Announces Myovant Sciences Positive One-Year Data from Phase 3 SPIRIT Extension Study of Once-Daily Relugolix Combination Therapy in Women with Endometriosis

•84.8% and 73.3% of women reported clinically meaningful reductions in dysmenorrhea (menstrual pain) and non-menstrual pelvic pain at one year •Data to be included in New Drug Application submission to U.S. Food and Drug Administration anticipated in first half of 2021 ....

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