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Intercept Pharmaceuticals said Monday that the Food and Drug Administration rejected its drug to treat the fatty liver disease known as NASH — a decision that has obvious negative consequences for Intercept but could also raise concerns for other drugmakers developing similar treatments.

According to a statement from Intercept, FDA officials determined the “predicted benefit” of the company’s drug called obeticholic acid, or OCA, “does not sufficiently outweigh the potential risks” to support approval as a treatment for patients with NASH. The FDA further recommended that Intercept submit additional efficacy and safety data from its Phase 3 clinical trial.

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  • The NASH companies that will benefit from this are the ones that have clinical outcomes for the endpoints. Not just some measure of histology under the microscope.

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