Intercept, Shares

Intercept Shares Plummet Following FDA’s Landmark Regulatory Action

13.09.2025 - 08:27:03

A Pattern of Mounting Regulatory Scrutiny

Intercept Pharmaceuticals faces a severe market downturn after the biopharma firm initiated a voluntary withdrawal of its key medication, Ocaliva, from the U.S. market. This decisive action came at the direct request of the Food and Drug Administration (FDA), which simultaneously imposed a full clinical hold on all U.S. studies involving the drug’s active ingredient, obeticholic acid. The one-two regulatory punch represents a devastating development for the company.

This market withdrawal is not an isolated incident but the culmination of persistent regulatory concerns. The FDA had previously refused to grant full approval for Ocaliva in November 2024, issuing a Complete Response Letter that cited significant safety issues. Agency officials specifically highlighted an elevated risk of severe liver injury... Read more...

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