Negative briefing docs underscore FDA's concerns for Intercept's OCA in NASH

Shares of US drug developer Intercept Pharmaceuticals (Nasdaq: ICPT) closed down 14.7% at $13.83 yesterday, after the US Food and Drug Administration released briefing document ahead of the FDA’s Gastrointestinal Drugs Advisory Committee.

The meeting set for May 19 will discuss Intercept’s obeticholic acid (OCA) for the treatment of pre-cirrhotic liver fibrosis due to non-alcoholic steatohepatitis (NASH).

Intercept’s push for an accelerated approval was first rejected by the FDA in 2020 after multiple delays. The drug is marketed as Ocaliva in primary biliary cholangitis.