(Reuters) – Shares of Intercept Pharmaceuticals Inc 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.
A panel of advisers to the U.S. 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.
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. The FDA usually follows the panel’s recommendations.
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.
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.
NASH, a progressive fatty liver disease, affects about 5% of adults in the U.S., according to the American Liver Foundation, and presents an unmet need with no approved drugs.
Drugmakers such as Novo Nordisk, Madrigal Pharmaceuticals and Akero Therapeutics are also developing treatments for the disease.
Intercept should immediately stop their late-stage NASH trial and first see if the data is encouraging, Baird analyst Brian Skorney said, adding that “beyond that last glimmer of hope in NASH”, the company can only maximize its market share in treating PBC.
(Reporting by Leroy Leo in Bengaluru; Editing by Shinjini Ganguli)
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