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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. ....
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 ....
Press release content from Globe Newswire. The AP news staff was not involved in its creation. UPDATE: Sumitovant Biopharma Announces Myovant Sciences Positive One-Year Data from Phase 3 . Sumitovant BiopharmaJanuary 26, 2021 GMT NEW YORK, LONDON,, Jan. 26, 2021 (GLOBE NEWSWIRE) Sumitovant Biopharma Ltd., a majority shareholder of Myovant Sciences (NYSE: MYOV), announced today that Myovant Sciences’ 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-menstrual pelvic pain over one year (52 weeks) with minimal and stable bone mineral density loss. The dat a are consistent with the efficacy and safety profile observed through 24 weeks in the Phase 3 SPIRIT 1 and SPIRIT 2 studies. These results will be included in the New Drug Applicat ....
ObsEva Provides Update on Yselty® (Linzagolix) Clinical Development Program
- European Medicines Agency Validates Yselty MAA for Uterine Fibroids; US NDA Planned for 1H 2021 - Phase 3 EDELWEISS 3 (Conducted in Europe and US) Study of Yselty for Treatment of Endometriosis is Progressing as Planned; Primary Endpoint Readout Expected 4Q 2021 - Phase 3 EDELWEISS 2 (Conducted in the United States) Yselty Endometriosis Study Discontinued Due to Enrollment Challenges; No Safety Concerns Identified
GENEVA, Switzerland and BOSTON, MA (Jan 11, 2021) – ObsEva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health, today announced several important updates on its Yselty program. ....