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Intercept: FDA Postpones Meeting On NDA For Liver Fibrosis Treatment; Stock Down

Intercept Pharmaceuticals Inc. (ICPT) said that the U.S. Food and Drug Administration has postponed its advisory committee meeting, which was tentatively scheduled on June 9, 2020, relating to the company's new drug application or NDA for obeticholic acid or OCA for the treatment of liver fibrosis due to nonalcoholic steatohepatitis or NASH.

In Friday pre-market trade, ICPT is trading at $81.57, down $10.12 or 11.04 percent.

The FDA has requested additional data on the NDA, and the company intends to submit within the next week, Intercept said in a statement.

The FDA has indicated that it will reach out to Intercept in the near future with a new proposed meeting date.

Intercept now anticipates that the FDA's review of its NDA will extend beyond the Prescription Drug User Fee Act (PDUFA) target action date of June 26, 2020.

Intercept previously announced the FDA's acceptance of the NDA and granting of priority review. OCA has received Breakthrough Therapy designation from the FDA for the treatment of NASH patients with liver fibrosis.

Nonalcoholic steatohepatitis or NASH is a serious progressive liver disease caused by excessive fat accumulation in the liver that induces chronic inflammation, resulting in progressive fibrosis (scarring) that can lead to cirrhosis, eventual liver failure, cancer and death. Advanced fibrosis is associated with a substantially higher risk of liver-related morbidity and mortality in patients with NASH.

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