ARTICLE | Company News

Intercept provides OCA clinical update

January 14, 2015 2:28 AM UTC

Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) gained $6.78 to $152.70 on Tuesday after updating investors on its clinical development plans for OCA obeticholic acid to treat liver diseases.

In December, Intercept began submitting a rolling NDA to FDA for OCA to treat primary biliary cirrhosis (PBC). This half, the company plans to complete the NDA submission and to submit an MAA to EMA. The oral farnesoid X receptor (FXR; NR1H4) agonist has Orphan Drug designation from FDA and EMA, as well as Fast Track designation from FDA, in the indication. ...