GAINESVILLE, Fla. – Cyclo Therapeutics, Inc. (Nasdaq: CYTH) (“Cyclo Therapeutics” or the “Company”), a clinical stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families suffering from disease, today announced a positive opinion has been adopted from the Paediatric Committee (PDCO) of the European Medicines...
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NEWARK, Calif. — CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, today announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for seladelpar, an investigational treatment for the management of primary biliary cholangitis (PBC)...
NEWARK, Calif. – CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced that seasoned biopharma executive Lewis Stuart has joined the company as Chief Commercial Officer. Mr. Stuart brings more than 25 years of...
NEWARK, Calif. — CymaBay Therapeutics, Inc., a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for investigational treatment, seladelpar, for the management of primary biliary cholangitis,...
NEWARK, Calif. – CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced that medical and clinical leader Dennis D. Kim, MD, MBA, is joining the company as Chief Medical Officer. “Improving patient lives is...
This weekend community members are uniting in the Gallatin Valley to raise awareness about a disease that currently has no cure. Researchers say cystic fibrosis is the most common genetic disease of children and young adults and over time weakens a person’s lungs and heart. Eight-year-old Carsten Manring of Three...
The inherited progressive disorder cystic fibrosis (CF) causes severe damage to the lungs, and other tissues in the body by affecting the cells that produce mucus, sweat, and digestive juices. In individuals carrying mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, which encodes an ion channel controlling the...
BETHESDA, Md. — The Cystic Fibrosis Foundation announced that it will provide up to $15 million to Prime Medicine for preclinical research into gene editing for cystic fibrosis. Prime Medicine is using a gene editing technology called prime editing — a technology that enables insertions or deletions of small segments of...
VANCOUVER, Wash. — CytoDyn Inc. (OTCQB: CYDY), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that the Company has submitted its revised HIV clinical trial protocol to the FDA. The Company believes this submission will lead to the removal of the...
SOUTH SAN FRANCISCO, Calif. and WASHINGTON – Cytokinetics, Incorporated (Nasdaq: CYTK) and The ALS Association today announced the continuation of their partnership in the fight against ALS. Cytokinetics is a sponsor of the 2021 ALS Roundtables and ALS Focus, a patient and caregiver led survey program to learn about individual...