Attempting to stem a significant downturn in its share price, Intercept Pharmaceuticals Inc. told an investor call Sept. 25 that its Phase III REGENERATE study of Ocaliva in non-alcoholic steatohepatitis will continue unaltered despite recent safety concerns about the drug in its already approved indication of primary biliary cholangitis (PBC).
Intercept Makes No Changes To Ocaliva NASH Study Despite PBC Safety Issues
Data monitoring safety board okays continuation of pivotal REGENERATE study in non-alcoholic steatohepatitis despite deaths of patients receiving Ocaliva for primary biliary cholangitis.
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