H.C. Wainwright doubtful of Intercept Pharma's NASH drug getting FDA approval

Intercept Pharmaceuticals

23/12/2022 18:31

(Updates)
    ** Biopharma co Intercept Pharmaceuticals Inc's shares
 ICPT.O  reverse course, fall 10.9% to ~$12
    ** Co re-submits application to U.S. FDA for obeticholic
acid (OCA) to treat 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 
    ** 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
    ** Brokerage H.C. Wainwright and Co skeptical of OCA's
approval 
        ** Even if approved, OCA's label is likely to be
restricted to NASH patients without late stage liver scarring -
brokerage
  
    ** Co expects FDA to classify this application as a Class 2
resubmission with a 6-month PDUFA target review time 
    ** Including session moves, stock down 26.3% YTD
 (Reporting by Pratik Jain in Bengaluru)
 ((Pratik.Jain@thomsonreuters.com;))