Intercept Gets Complete Response Letter From FDA For Obeticholic Acid As A Treatment For Pre-Cirrhotic Fibrosis Due To NASH
Portfolio Pulse from Benzinga Newsdesk
Intercept Pharmaceuticals received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for obeticholic acid (OCA) as a treatment for pre-cirrhotic fibrosis due to NASH. The company will discontinue all NASH-related investment and restructure its operations to focus on rare and serious liver diseases.
June 22, 2023 | 9:46 pm
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Intercept Pharmaceuticals' stock may be negatively impacted by the FDA's CRL for its obeticholic acid treatment for NASH, leading to discontinuation of NASH-related investment and restructuring.
The FDA's CRL for Intercept's obeticholic acid treatment for NASH is a significant setback for the company, as it will lead to discontinuation of NASH-related investment and restructuring of the company's operations. This is likely to have a negative impact on the company's stock price in the short term.
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