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FDA Advisory Committee Votes Against Approval for NASH Drug

The committee members voted 15 to 1 to defer approval, citing concerns with increased risk for drug-induced liver injury while on the drug.

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Intercept Pharma (ICPT) Announces Vote Not Favoring Obeticholic Acid as a Treatment for Pre-Cirrhotic Fibrosis due to NASH

Intercept Pharma (ICPT) Announces Vote Not Favoring Obeticholic Acid as a Treatment for Pre-Cirrhotic Fibrosis due to NASH
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Intercept Announces Outcome of FDA Advisory Committee Meeting for Obeticholic Acid as a Treatment for Pre-Cirrhotic Fibrosis due to NASH

Intercept Announces Outcome of FDA Advisory Committee Meeting for Obeticholic Acid as a Treatment for Pre-Cirrhotic Fibrosis due to NASH
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Intercept Pharma (ICPT) Reports Efficacy and Safety Data from Phase 3 REGENERATE Study

Intercept Pharma (ICPT) Reports Efficacy and Safety Data from Phase 3 REGENERATE Study
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Intercept Resubmits New Drug Application to U S FDA for

NDA supported by robust NASH clinical development program, including two positive interim analyses from the Phase 3 REGENERATE study NDA includes.

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