NDA is supported by positive data from two Phase 3 studies and a long-term extension study, demonstrating sustained reduction in heavy menstrual bleeding while maintaining bone health through one year If approved, relugolix combination tablet would be the first once-daily, oral treatment for women with heavy menstrual bleeding associated with uterine fibroids in the U.S. NEW […]
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Category: Sumitovant
Sumitovant Biopharma Announces Myovant Sciences’ Additional Positive Efficacy and Cardiovascular Safety Data from Phase 3 HERO Study of Once-Daily, Oral Relugolix in Advanced Prostate Cancer and Publication in the New England Journal of Medicine
Phase 3 data presented in oral presentation during the ASCO20 Virtual Scientific Program, with simultaneous publication in the New England Journal of Medicine Presentation expands on previous results demonstrating superiority of relugolix to leuprolide acetate, with additional data on testosterone suppression and recovery, prostate-specific antigen (PSA) response, and cardiovascular safety Relugolix treatment showed a 54% […]
Sumitovant Biopharma’s Family of Companies Achieve Multiple Clinical and Corporate Milestones in the First Full Quarter of Sumitovant’s Operation
Urovant Announces Publication of Phase 3 EMPOWUR Trial Results in the Journal of Urology Urovant Announces U.S. FDA Acceptance of NDA for Vibegron in OAB Myovant Submits Marketing Authorization Application to the European Medicines Agency for Relugolix Combination Therapy in Women with Uterine Fibroids Altavant Sciences Acquires Onspira Therapeutics Adding Research Program to Potentially Address […]
Sumitovant Biopharma Announces Publication of Myovant Abstracts Detailing Additional Efficacy and Safety Findings from Phase 3 Liberty Studies in Uterine Fibroids in Obstetrics & Gynecology
Abstracts accepted for presentation in oral and poster sessions at the 2020 American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting Data from Phase 3 program shows treatment with relugolix combination therapy can result in significant improvements in pain and quality of life in women with heavy menstrual bleeding associated with uterine […]
Sumitovant Biopharma Reports Key Clinical and Regulatory Milestones by Myovant Sciences
Myovant Sciences submits New Drug Application (NDA) to the FDA for once-daily, oral relugolix (120 mg) for the treatment of men with advanced prostate cancer. Myovant announces positive results from Phase 3 SPIRIT 2 study evaluating once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with […]
Sumitovant Biopharma Reports Key Clinical and Regulatory Milestones by Myovant Sciences
Sumitovant Biopharma Reports Key Clinical and Regulatory Milestones by Myovant Sciences Myovant Sciences submits New Drug Application (NDA) to the FDA for once-daily, oral relugolix (120 mg) for the treatment of men with advanced prostate cancer. Myovant announces positive results from Phase 3 SPIRIT 2 study evaluating once-daily relugolix combination therapy (relugolix 40 mg plus […]
Sumitovant Biopharma Created and Launched as Sumitomo Dainippon Pharma and Roivant Sciences Close Transaction for Strategic Alliance
Sumitomo Dainippon Pharma and Roivant Sciences complete strategic alliance and formation of new company, Sumitovant Biopharma, a wholly owned subsidiary of Sumitomo Dainippon Pharma Sumitovant will be led by Chief Executive Officer Myrtle Potter, former Roivant Vant Operating Chair and President and COO of Genentech Roivant has received USD $3 billion from Sumitomo Dainippon Pharma […]
Sumitomo Dainippon Pharma and Roivant Sciences Sign Definitive Agreement for Strategic Alliance
Alliance will include Roivant’s ownership interests in Myovant, Urovant, Enzyvant, Altavant, and Spirovant, a new company focused on developing innovative gene therapies for cystic fibrosis Sumitomo Dainippon Pharma will leverage Roivant’s technology platforms to digitally transform its business The new company will be led by Chief Executive Officer Myrtle Potter, former President and COO of […]
Sumitomo Dainippon Pharma and Roivant Sciences Enter into a Memorandum of Understanding to Create Broad Strategic Alliance to Deliver Promising New Medicines to Patients
Sumitomo Dainippon-Roivant Alliance (“Alliance”) encompasses up to 11 biopharmaceutical Vants with more than 25 innovative clinical programs and multiple potential product launches from 2020 to 2022, and access to key elements of Roivant’s proprietary technology platforms including DrugOme and Digital Innovation Sumitomo Dainippon Pharma to enter into contract agreements with Roivant Health technology Vants including […]