SOUTH SAN FRANCISCO, Calif. — Encoded Therapeutics, Inc. (“Encoded”), a clinical-stage biotechnology company developing precision genetic medicines for severe neurological disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to ETX101 for the treatment of SCN1A+ Dravet syndrome. This designation is in addition to...
treatment News
SOUTH SAN FRANCISCO, Calif. — Encoded Therapeutics Inc., a biotechnology company focused on developing genetic medicines for severe central nervous system (CNS) disorders, today outlined the global development strategy for its lead gene therapy candidate, ETX101, for the treatment of SCN1A+ Dravet syndrome. Individuals with Dravet syndrome, the most common...
SOUTH SAN FRANCISCO, Calif. — Encoded Therapeutics Inc., a clinical-stage genetic medicines company, today announced upcoming presentations of interim clinical data from its ongoing POLARIS Phase 1/2 open-label trials evaluating ETX101 in children with SCN1A+ Dravet syndrome. The data will be featured at the American Epilepsy Society Annual Meeting, taking place...
SAN DIEGO – Endeavor BioMedicines, a clinical-stage precision medicine company targeting the core drivers of multiple terminal diseases including oncology and fibrosis, announced that the company has dosed its first patient in a Phase 2 trial of taladegib (ENV-101) to treat idiopathic pulmonary fibrosis (IPF). Taladegib is a small-molecule inhibitor...
SAN DIEGO, Calif. — Endeavor BioMedicines, a clinical-stage biotechnology company developing medicines with the potential to deliver transformational clinical benefits to patients with life-threatening diseases, today announced successful completion of its Phase 2a clinical trial evaluating the company’s lead investigational compound, ENV-101, in patients with idiopathic pulmonary fibrosis (IPF). ENV-101...
SAN DIEGO, Calif. — Endeavor BioMedicines (“Endeavor”), a clinical-stage biotechnology company developing medicines with the potential to deliver transformational clinical benefits to patients with life-threatening diseases, today announced that The Lancet Respiratory Medicine has published results from a Phase 2a trial evaluating the safety and efficacy of taladegib (ENV-101) in patients with idiopathic...
Northbrook, Ill. — Endevica Bio, a privately held company developing first-in-class peptide drug candidates, announced today the dose administration for the first patient in a Phase 2 trial for its experimental drug TCMCB07 (B07) to prevent weight loss in cancer patients undergoing chemotherapy. The trial, being conducted in partnership with...
SAN DIEGO, Calif. – Endure Biotherapeutics, Inc. (Endure Bio®), a pioneer in engineered engraftable microbial therapeutics, today announced it has been awarded a Phase I Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH). The funding will support the development of a...
BASEL, Switzerland and LINCOLNSHIRE, Illinois — Vaderis Therapeutics today announced that data from its randomized, double-blind, placebo-controlled, multi-center proof-of-concept study and long-term extension of engasertib (VAD044) in Hereditary Hemorrhagic Telangiectasia (HHT) have been published in The New England Journal of Medicine (NEJM). This peer-reviewed publication marks an important milestone following initial release of study...
WILMINGTON, Del. – AstraZeneca Pharmaceuticals LP and Daiichi Sankyo’s supplemental Biologics License Application (sBLA) for ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been accepted and granted Priority Review in the US for the treatment of adult patients with unresectable or metastatic HER2-positive (immunohistochemistry [IHC] 3+) solid tumors who have received prior treatment or...