No Read-Through Expected: NASH Field Unfazed By Intercept’s FDA Rejection

While analysts were divided on whether there were broader implications for non-alcoholic steatohepatitis (NASH) R&D following the complete response letter that Intercept Pharmaceuticals Inc. revealed on 29 June, executives from three companies with mid-stage or later NASH candidates think the US Food and Drug Administration’s concerns are specific to Intercept and its drug, obeticholic acid (OCA).

Intercept CEO Mark Pruzanski indicated during a same-day investor call that it was possible that shifting terrain in NASH – including the Phase III miss by Genfit SA’s elafibranor...