The Update On Intercept Pharmaceuticals
Intercept Pharmaceuticals (ICPT) is a well-recognized commercial stage mid-cap ($3.29B) liver therapeutics company. Its lead drug candidate is obeticholic acid ((OCA)), a prototype FXR agonist. OCA is currently in two Phase 3 clinical trials for NASH fibrosis and NASH compensated cirrhosis. The data readout for the NASH fibrosis trial is imminent. It is anticipated that OCA would successfully achieve one of the two clinical endpoints mandated by FDA for accelerated conditional approval (see below).
A significant proportion of OCA treated patients relative to placebo achieving at least