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 FDA-approved NASH treatment. In 2020, the FDA rejected Intercept’s application for NASH on the grounds that the benefits of obeticholic acid (OCA) did not outweigh potential risks — aRead More

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