![]() ![]() SVB Securities analyst Thomas Smith believes the company may discontinue the NASH program and pivot its focus on only primary biliary cholangitis (PBC), a chronic liver disease for which OCA was approved in 2016 and is sold under brand name, Ocaliva. Intercept will provide an update on OCA once the FDA decides on the drug's application by June 22, and if the regulator declines to approve it, the company will shift its focus to becoming profitable, CEO Jerry Durso said in a conference call on Monday. ![]() ![]() The FDA usually follows the panel's recommendations. Shares of Intercept, which fell nearly 15% last week after the FDA's staff reviewers flagged serious concerns related to the drug ahead of the meeting, were down about 16% at $11.50 in early trading. Food and Drug Administration said on Friday study data suggested the benefits of Intercept's drug, obeticholic acid (OCA), did not outweigh the risks in patients with NASH (non-alcoholic steatohepatitis) and fibrosis, or scarring. May 22 (Reuters) - Shares of Intercept Pharmaceuticals Inc (ICPT.O) fell about 16% on Monday over concerns about the prospects of the company's drug to treat a type of fatty liver disease after the regulator's advisory panel voted to defer an accelerated approval.Ī panel of advisers to the U.S. ![]()
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