Intercept Pharmaceuticals, Inc.
|Company Name||Intercept Pharmaceuticals, Inc.|
On June 29, 2020, Intercept disclosed receipt of a complete response letter ("CRL") from the U.S. Food and Drug Administration ("FDA") regarding the New Drug Application for obeticholic acid ("OCA") for the treatment of fibrosis due to nonalcoholic steatohepatitis ("NASH"). According to the CRL, the FDA found that "the predicted benefit of OCA based on a surrogate histopathologic endpoint remains uncertain and does not sufficiently outweigh the potential risks to support accelerated approval for the treatment of patients with liver fibrosis due to NASH."
On this news, the Company's share price fell as much as $29.78, or 38%, during intraday trading on June 29, 2020.
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