Intercept shares tumble on concerns over NASH drug prospects

Intercept Pharmaceuticals

22/05/2023 12:54

May 22 (Reuters) - Shares of Intercept Pharmaceuticals
Inc  ICPT.O  fell 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 that 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.
    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 after numerous
clinical failures by several drugmakers.
    Drugmakers such as Novo Nordisk  NOVOb.CO , Madrigal
Pharmaceuticals  MDGL.O  and Akero Therapeutics  AKRO.O  are
also developing treatments for the disease, and competition is
expected to increase by the time Intercept will be ready with
its pivotal trial data.
    The best next step for Intercept at this point would be to
immediately halt an ongoing late-stage trial to see if there are
any encouraging signals in the larger dataset that could open
the door for a potential submission for full approval, Baird
analyst Brian Skorney said.
    "Beyond that last glimmer of hope in NASH", Skorney said,
the company can only maximize its market share in treating PBC. 
    Intercept's PBC drug use, however, was restricted in 2021 in
patients with advanced cirrhosis of the liver because of the
potential for serious harm.

 (Reporting by Leroy Leo in Bengaluru; Editing by Shinjini
Ganguli)
 ((Leroy.Dsouza@thomsonreuters.com ; Twitter: https://twitter.com/LeroyLeo7;))