Why Intercept Pharmaceuticals Is Plunging Today

Shares of Intercept Pharmaceuticals (NASDAQ: ICPT) are plunging on Friday after the company announced some bad news regarding its new drug application (NDA) for Ocaliva as a treatment for fibrosis (buildup of scar tissue) in the liver due to nonalcoholic steatohepatitis (NASH). Intercept's shares are down by 14.4% as of 11:34 a.m. today.

Intercept submitted an NDA to the U.S. Food and Drug Administration (FDA) for Ocaliva as a treatment for fibrosis due to NASH back in September 2019, and Ocaliva was granted priority review by the health industry regulator. Also, the FDA tentatively scheduled an advisory committee meeting regarding this application for June 9, 2020. Today Intercept announced that the FDA has decided to postpone this meeting indefinitely. This decision by the FDA will delay the approval process for Ocaliva as a treatment for fibrosis due to NASH.

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