Intercept Pharmaceuticals, Inc. is a biopharmaceutical company focused on bringing novel therapeutics to treat chronic liver diseases to market. The company's focus is on treating orphan and more prevalent liver diseases with limited treatment options. The company received FDA approval for Ocaliva an farnesoid X receptor against in combination with ursodeoxycholic acid, for the treatment of primary biliary cholangitis in adults with an inadequate response to UDCA or as monotherapy in adults who are intolerant to UDCA. Ocaliva was approved in the EU for the same indication. The drug was approved in Canada. OCA is also being developed for additional indications like primary sclerosing cholangitis and non-alcoholic steatohepatitis. The FDA accepted its New Drug Application for OCA seeking accelerated approval for the treatment of fibrosis due to NASH. Intercept received a complete response letter from the FDA stating that its NDA for OCA for the treatment of liver fibrosis due to NASH could not be approved.