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Intercept Makes No Changes To Ocaliva NASH Study Despite PBC Safety Issues

 
• By Joseph Haas

Data monitoring safety board okays continuation of pivotal REGENERATE study in non-alcoholic steatohepatitis despite deaths of patients receiving Ocaliva for primary biliary cholangitis.

Liver

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).

Over a two-day period last week, Intercept’s stock price decreased 38% from $98.59 to $61.59 as US FDA issued a safety communication outlining 19 patient deaths and 11 serious liver...

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