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Why Are Intercept Pharmaceuticals Shares Falling Today?

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·1 min read
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  • Intercept Pharmaceuticals Inc (NASDAQ: ICPT) has withdrawn its European marketing application seeking approval for obeticholic acid (OCA) for liver fibrosis due to nonalcoholic steatohepatitis (NASH).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.

  • Related Link: Intercept Posts Long-Term Data For Obeticholic Acid In Chronic Liver Disease Patients.

  • Price Action: ICPT shares are down 8.53% at $15.65 during the market session on the last check Thursday.

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