ARTICLE | Company News

Ocaliva warning could remove overhang on Intercept shares

February 1, 2018 10:00 PM UTC

Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) announced the addition of a boxed warning to FDA's label of Ocaliva obeticholic acid stating that hepatic decompensation and failure can occur in incorrectly dosed primary biliary cholangitis (PBC) patients with Child-Pugh Class B or C hepatic impairment or decompensated cirrhosis.

The news could remove an overhang on Intercept's stock, which hit an intra-day high of $70.74 -- up 14% -- Thursday before finishing the day off $0.08 at $62.02. Some investors had been concerned that FDA could implement stronger measures, such as limiting the drug's use to patients with milder disease, holding an advisory committee meeting or otherwise restricting Ocaliva's use. Intercept said the warning addresses about 2-3% of the PBC patient population...