BOULDER, Colo. — Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced that the European Medicines Agency (EMA) has granted Orphan Drug Designations for sevasemten for the treatment of Becker muscular dystrophy (Becker) and for the treatment of Duchenne muscular dystrophy (Duchenne). Sevasemten is an investigational...
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BOULDER, Colo. — Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for EDG-5506 for the treatment of Duchenne. EDG-5506 is an investigational orally administered small molecule designed to prevent contraction-induced muscle damage...
BOULDER, Colo. – Edgewise Therapeutics, Inc., (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for rare muscle disorders, today announced the publication of the first cross-sectional, retrospective study to describe selective elevation of fast but not slow skeletal muscle fiber injury biomarkers in the...
BOULDER, Colo. – Edgewise Therapeutics, Inc., (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for rare muscle disorders, today announced the appointment of Joanne M. Donovan, M.D., Ph.D., to the position of Chief Medical Officer. Dr. Donovan will be responsible for leading clinical, medical...
BOULDER, Colo. — Edgewise Therapeutics, Inc., a leading muscle disease biopharmaceutical company, today announced the launch of an educational website dedicated to the Becker muscular dystrophy (Becker) community: www.beckermusculardystrophy.com. This is the first website solely focused on providing Becker-specific resources to help individuals and caregivers better understand the disease, learn...
New open label data in Becker demonstrated sustained disease stabilization up to three years, reinforcing prior clinical findings Ongoing pivotal trial and FDA Type C meeting provide clear path to potential sevasemten registration as the first ever therapy for Becker Encouraging Phase 2 observations in Duchenne define the dose and...
BEIJING & CAMBRIDGE, Mass. – EdiGene, Inc. (“Company”, or “EdiGene”), today announced the first patient enrolled in multicenter Phase I clinical study of its investigational gene-editing hematopoietic stem cell therapy ET-01 for patients with transfusion dependent β-thalassemia at the Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC, and...
FUKUOKA, Japan — EditForce, Inc. (Headquarters: Fukuoka, Japan) is pleased to announce that a research paper on the results of a joint study with the research group led by Professor Masayuki Nakamori of the Department of Neurology of the Yamaguchi University Graduate School of Medicine, and Professor Hideki Mochizuki of the Department of Neurology of...
IRVINE, Calif. — Edwards Lifesciences (NYSE: EW) announced today that the U.S. Food and Drug Administration (FDA) has approved its transcatheter aortic valve replacement (TAVR) therapy, the SAPIEN 3 platform, for severe aortic stenosis (AS) patients without symptoms, marking the first FDA approval for TAVR in asymptomatic patients. Approval of...
An over-the-counter prostate cancer test kit could be coming to a pharmacy near you, thanks to the collaborative work of a University of Central Florida chemist and M.D. Anderson Cancer Center Orlando researchers. UCF’s Qun “Treen” Huo and M.D. Anderson-Orlando’s Dr. Cheryl Baker and Jimmie Colon teamed up about 18...