Intercept Pharma down as FDA staff raises concerns over liver disease treatment

Intercept Pharmaceuticals

17/05/2023 15:44

(Updates)
    ** Shares of Intercept Pharmaceuticals Inc  ICPT.O  fall
20.5% to $12.9 - biggest pct loser across U.S. stock exchanges 
    ** FDA staff reviewers raised various safety concerns about
ICPT's oral tablets for the treatment of a type of fatty liver
disease
    ** During the course of the review, FDA identified modest
benefits and serious risks of using ICPT's drug for treatment of
nonalcoholic steatohepatitis (NASH) - the staff said in the
document 
    ** The data from interim analysis showed the drug being
superior compared to placebo in terms of reduction in liver
scarring in NASH patients after 18 months, but FDA staff
expressed uncertainty over meaningful clinical outcomes
    ** NASH is a serious progressive liver disease in people who
drink little to no alcohol but have excessive fat accumulation
that starts causing inflammation and cell damage in the organ
    ** FDA staff has asked the regulator's advisory panel to
consider whether the modest benefits from using the drug for
NASH treatment outweigh the serious risks associated with it;
the panel meeting is set for May 19
    ** The U.S. health regulator will take a final decision on
Intercept's drug by June 22
    ** Including session losses, stock up ~5% YTD

 (Reporting by Khushi Mandowara in Bengaluru)
 ((Khushi.Mandowara@thomsonreuters.com;))