Intercept Pharma gains on resubmitting NASH drug for FDA review

Hanall Biopharma

23/12/2022 14:07

** Shares of biopharma co Intercept Pharmaceuticals Inc
 ICPT.O  rise 7.7% to $14.5 premarket 
    ** Co re-submits application to U.S. FDA for obeticholic
acid for the treatment of liver scarring due to non-alcoholic
steatohepatitis (NASH)
    ** NASH is a serious progressive liver disease caused by
excessive fat accumulation in the liver 
    ** Co says the application includes two positive interim
analysis data from its late-stage NASH trial 
    ** That follows ICPT's trial in September, which failed to
meet the main goal as obeticholic acid when compared with
placebo, was not statistically significant in improving
fibrosis, with no worsening of NASH 
    ** The health regulator had earlier declined to approve the
drug on uncertainty over whether benefits of treatment outweigh
its risk and recommended co to submit additional data from the
late-stage study
    ** The latest set of study shows 25 mg dosage of OCA had a
statistically significant improvement in liver fibrosis by at
least 1 stage without worsening of NASH, ICPT says
    ** Co expects FDA to classify this application as a Class 2
resubmission with a PDUFA target review time of 6 months
    ** Stock down 17.3% YTD, as of last close 
 (Reporting by Pratik Jain in Bengaluru)
 ((Pratik.Jain@thomsonreuters.com;))