[4] In November 2024, the U.S. Food and Drug Administration (FDA) declined to grant full approval for Ocaliva as a treatment for primary biliary cholangitis (PBC), a rare autoimmune liver disease.

This decision followed a September 2024 advisory committee meeting where 13 out of 14 panel members concluded that Intercept's data did not adequately demonstrate Ocaliva's clinical benefit.

The FDA is continuing to review data from these studies, including trial 747-302 (NCT02308111), and has noted concerns about serious liver injury in some patients without severe scarring.

On January 9, 2014, the stock skyrocketed from $72.39 to $275.49, or about 280%, after a planned interim analysis by the independent data safety monitoring board showed that Obeticholic acid met the main goal (improvement of liver histology) at the mid-stage in the FLINT trial in NASH, sponsored by NIDDK.

In March 2014, the company released the results of the POISE study of Obeticholic acid in PBC, which showed the drug met the trial's primary endpoint of a reduction in serum alkaline phosphatase, a biomarker for the disease.