FDA Strikes Out Intercept Pharma's Obeticholic Acid Application For NASH Patients, Focus Shifts To Rare Liver Diseases
Portfolio Pulse from Vandana Singh
The FDA has issued a Complete Response Letter to Intercept Pharmaceuticals' marketing application for obeticholic acid (OCA) for pre-cirrhotic fibrosis due to NASH. Intercept will discontinue NASH-related investment and restructure to focus on rare liver diseases, aiming for profitability in 2024. The company will reduce its workforce by one-third and prioritize a fixed-dose combination of OCA and bezafibrate.
June 23, 2023 | 11:54 am
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Intercept Pharmaceuticals' OCA application for NASH patients was denied by the FDA, leading the company to restructure and focus on rare liver diseases. The workforce will be reduced by one-third.
The FDA's denial of Intercept Pharmaceuticals' OCA application for NASH patients is a significant setback for the company. As a result, Intercept will discontinue NASH-related investment and restructure its operations to focus on rare liver diseases. This will lead to a reduction in the workforce by one-third, which could negatively impact the company's stock price in the short term.
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