Company remains on track to resubmit new drug application (NDA) for OCA in its lead indication of fibrosis due to NASH by year end based on its positive Phase 3 REGENERATE study MORRISTOWN, N.J., Sept ...
On Friday, the Gastrointestinal Drugs Advisory Committee voted against the approval of OCA for treating nonalcoholic steatohepatitis (NASH). The recommendation to delay approval until additional trial ...
Shares of Intercept Pharmaceuticals, Inc. ICPT gained 12.4% in the last six months compared with the industry’s growth of 0.3%. Investors are upbeat on the performance of lead drug Ocaliva and the ...