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Intercept Pharmaceuticals Inc (NASDAQ: ICPT) has withdrawn its European marketing application seeking approval for obeticholic acid (OCA) for liver fibrosis due to nonalcoholic steatohepatitis (NASH).
The initial application was filed in December 2019 was supported by the interim analysis results from the Phase 3 REGENERATE study, which remains ongoing.
Intercept says it expects to generate additional efficacy and safety data from REGENERATE, including a full reread of Month 18 biopsies using a new consensus biopsy reading approach and adjudicated safety data to support a potential refiling in the U.S.
The established application timeline could not be extended to allow for the submission of the additional data, which is expected in the early part of 2022.
Based on the data review submitted to date, the CHMP could not determine a positive benefit-risk.
As a result, the Company has decided to withdraw the application.
Price Action: ICPT shares are down 8.53% at $15.65 during the market session on the last check Thursday.
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