Intercept's NASH drug is again rejected by FDA, leading the company to restructure in pivot from disease
Intercept Pharmaceuticals’ NASH drug obeticholic acid was rejected by the FDA for a second time on Thursday, and the company says it will now discontinue “all NASH-related investment,” pivot its focus to rare and serious liver diseases, and lay off about one-third of its workforce.
A resubmission would require, at a minimum, complete data from the long-term outcomes phase of its pivotal REGENERATE study, Intercept said it was told by the FDA.
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