Intercept tumbles on concerns over prospects of fatty liver disease drug (updated)

Intercept Pharmaceuticals

22/05/2023 14:46

(Updates shares in paragraph 1, adds company comments in
paragraph 4)
    By Leroy  Leo
       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. 
    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  NOVOb.CO , Madrigal
Pharmaceuticals  MDGL.O  and Akero Therapeutics  AKRO.O  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)
 ((Leroy.Dsouza@thomsonreuters.com ; Twitter: https://twitter.com/LeroyLeo7;))