MYOV News and Press, Myovant Sciences Ltd. From 04/21/22

CAMBRIDGE, Mass. and BASEL, Switzerland, April 21, 2022 (GLOBE NEWSWIRE) -- Enzyvant, a commercial-stage biotechnology company with a focus on regenerative medicines for rare diseases, announced today plans to develop a Good Manufacturing Practice (GMP)-compliant regenerative medicine manuf...

Myovant Sciences ( NYSE: MYOV ) and Pfizer ( NYSE: PFE ) announced an update for an sNDA for MYFEMBREE, which is designed to manage severe to moderate pain linked to endometriosis. According to the ongoing review of this new application, the FDA provided notice that ...

Myovant markets and sells Relugolix - a once-daily, oral, gonadotropin-releasing hormone (“GnRH”) receptor antagonist - across two indications. These are prostate cancer, as ORGOVYX, and menstrual bleeding caused by uterine fibroids, as MYFEMBREE. The company splits ...

Shares of Myovant Sciences plunged this week after a regulatory setback for Myfembree. No reasons were provided by the FDA yet, and the deficiency letter comes as a big surprise. Orgovyx in advanced prostate cancer remains the key revenue growth driver for the company. Myovant...

Gainers: Lixte Biotechnology Holdings (LIXT) +205%. PolarityTE (PTE) +96%. Biodesix (BDSX) +29%. MiNK Therapeutics (INKT) +27%. Enservco (ENSV) +25%. Actinium Pharmaceuticals (ATNM) +21%. Compass Therapeutics (CMPX) +21%. Sunshine Biopharma (SBFM) +22%. Singularity Future Technology (SGLY) +2...

Shares of Myovant Sciences (NYSE: MYOV) had crashed by 23.4% as of 11 a.m. ET on Tuesday. The steep decline came after the company and its partner, Pfizer (NYSE: PFE) , announced that the Food and Drug Administration (FDA) had identified deficiencies in the Supplemental New ...

Gainers: Lixte Biotechnology LIXT +263%. BioCardia BCDA +29%. Biodesix BDSX +27%. Aeglea BioTherapeutics AGLE +16%. Actinium Pharmaceuticals ATNM +14%. Losers: Hoth Therapeutics HOTH -30%. Altamira Therapeutics CYTO -29%. Myovant Sciences (MYO...

BASEL, Switzerland and NEW YORK, April 12, 2022 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV) and Pfizer (NYSE: PFE) announced today an update on the Supplemental New Drug Application (sNDA) for MYFEMBREE® (relugolix 40 mg, estradiol 1 mg and norethindrone acetate 0.5 mg) for the m...

Supplemental New Drug Application of MYFEMBREE for pain associated with endometriosis has been submitted to FDA; PDUFA date of May 6, 2022 has been set. If FDA approval of MYFEMBREE for pain associated with endometriosis is achieved, then Myovant would be eligible to earn $100 million...

Commercial-stage pharma company, Myovant Sciences (MYOV -0.7%) announced Friday that an expert panel of the European Medicines Agency (EMA) issued a positive opinion on Orgovyx for its approval in the treatment of adults with advanced hormone-sensitive prostate cancer. The decision by the EMA...