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Intercept 'disappointed' after FDA setback for top NASH contender; stock drops 16%

Intercept Pharmaceuticals saw a 16% drop in its stock value after an FDA advisory committee declined to approve obeticholic acid in pre-cirrhotic patients with liver fibrosis due to nonalcoholic steatohepatitis. The vote before the Gastrointestinal Drug Advisory Committee on May 19 was Intercept’s second bid to put its 25 mg obeticholic acid product (Ocaliva) in a lead position as the first
Thomas Capozza Jerry Durso Ruby Mehta Intercept Pharmaceuticals Gastrointestinal Drug Advisory Committee On Office Of New Drugs
Source: healio.com

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SRN - US News - Taylorville Daily News

By Leroy Leo and Sriparna Roy (Reuters) -A panel of advisers to the U.S. Food and Drug Administration, wary of the safety of Intercept Pharmaceuticals’ oral drug for a type of fatty liver disease, recommended on Friday holding off on an accelerated approval of the medicine. The panel of outside experts voted 15-to-1 against the approval for obeticholic acid (OCA) based on surrogate biomarker data suggesting it was likely to benefit patients with NASH (non-alcoholic steatohepatitis) and ...
United States Leroy Leo Jacqueline Wong James Floyd Kanjyik Ghosh Ruby Mehta

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