Shares of CymaBay Therapeutics soared after the company announced the experimental primary biliary cholangitis (PBC) treatment seladelpar hit the mark in a Phase III study that sets up potential regulatory approval for this indication.
Following negative interim data from the company’s experimental treatment for non-alcoholic steatohepatitis (NASH) and fibrosis, France’s GENFIT will discontinue the Phase III RESOLVE-IT study of elafibranor in this indication.
CymaBay Therapeutics Inc. is scrapping two mid-stage trials of the liver disease drug seladelpar after biopsies found a type of liver damage in some patients, sending the company’s shares down more than 75 percent.
Genfit’s elafibranor was granted Breakthrough Therapy Designation by the U.S. FDA for the treatment of Primary Biliary Cholangitis (PBC) in adults with inadequate response to ursodeoxycholic acid.
The FDA warned health-care providers to stick to dosing recommendations for Intercept Pharma’s liver disease medicine Ocaliva after 19 patient deaths were reported.
Intercept Pharmaceuticals Inc. said its liver drug received conditional approval from the European Commission to treat patients with primary biliary cholangitis (PBC).
Drugmaker Intercept Pharmaceuticals Inc.’s drug to treat a rare liver condition was conditionally approved an advisory committee to the European Medicines Agency.