FibroGen Receives FDA Clearance to Proceed with Clinical Study of FG-3019 in Duchenne Muscular Dystrophy

FibroGen, Inc. (Nasdaq:FGEN), a research-based biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has completed its review of the Company’s investigational new drug (IND) application for the study of FG3019 in patients with Duchenne muscular dystrophy (DMD), and clinical study may proceed. FG-3019 is a fully human monoclonal antibody that inhibits the activity of connective tissue growth factor (CTGF), a common mediator of fibrotic disease. FG-3019 is currently in Phase 2 clinical studies for idiopathic pulmonary fibrosis and pancreatic cancer

Capricor Therapeutics Research Update for Duchenne

Capricor Therapeutics and CureDuchenne hosted a webinar on June 19, 2015. The presentation discussed the HOPE-DUCHENNE Trial. The U.S. Food and Drug Administration has cleared Capricor’s Investigational New Drug Application for the clinical development of CAP-1002 for the treatment of patients with Duchenne muscular dystrophy.

Akashi Reports Positive Clinical Data on HT-100

Akashi Therapeutics Inc., a clinical stage biopharmaceutical company developing treatments for Duchenne muscular dystrophy (DMD), today announced positive interim clinical data from an ongoing Phase 1b/2a clinical program with HT-100 (delayed-release halofuginone) an orally available, small molecule developed to reduce fibrosis and inflammation and promote healthy muscle fiber regeneration in boys with DMD.