Intercept wins priority review for OCA

The FDA granted Intercept's ($ICPT) obeticholic acid (OCA) application for primary biliary cirrhosis a priority review, setting the PDUFA date at February 29, 2016. That move slices four months off the regulatory review process for one of the most closely watched drugs in the industry pipeline, with blockbuster aspirations for treating NASH. "Priority review designation accelerates the FDA review timelines, potentially bringing Intercept closer to its goal of delivering the first new medicine for PBC in close to 20 years," says CEO Mark Pruzanski. Release