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With a Friday advisory committee meeting looming, the sole indication for Intercept Pharmaceuticals’ Ocaliva appears to be at risk as the regulator flags issues regarding its post-marketing results.

The regulator has delayed its respective decision dates on whether to grant full approval to Amgen’s Lumakras in metastatic colorectal cancer and Intercept Pharmaceuticals’ Ocaliva for primary biliary cholangitis.

Ocaliva recently failed to secure the FDA’s traditional approval for primary biliary cholangitis due to safety concerns.

Alfasigma S.p.A. (“Alfasigma”) and Intercept Pharmaceuticals, Inc. (“Intercept”) announced today the completion of the acquisition of Intercept by Alfasigma through its wholly owned subsidiary Interstellar Acquisition Inc.

Intercept Pharmaceuticals, Inc. announced nine abstracts related to primary biliary cholangitis and alcohol-related liver disease will be presented at EASL Congress 2024.

Intercept Pharmaceuticals, Inc., a biopharmaceutical company and wholly owned subsidiary of Alfasigma S.p.A. focused on the development and commercialization of novel therapeutics to treat rare and serious liver diseases, announced five abstracts on primary biliary cholangitis will be presented at Digestive Disease Week® 2024.