Intercept Pharma down as FDA staff raise concerns for liver disease treatment

Intercept Pharmaceuticals

17/05/2023 14:21

** Shares of Intercept Pharmaceuticals Inc  ICPT.O  fall
20.5% to $12.9 before the bell 
    ** FDA staff reviewers raised safety concerns about ICPT' s
oral tablets for treatment of a type of fatty liver disease
    ** ICPT's drug can cause significant drug-induced liver
injury - FDA briefing document
    ** The drugmaker had resubmitted its application in July
last year based on interim analysis that showed the treatment
led to statistically significant reduction in fibrosis in
patients with NASH after 18 months compared to the placebo 
    ** 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 will commence a meeting of outside experts to provide
a recommendation on the drug - set for May 19 
    ** U.S. health regulator is set to make final decision on
Intercept's drug by June 22
    ** Up to Tuesday's close, stock had fallen ~31% YTD
    

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