Before the market opened on May 17, 2023, the U.S. Food and Drug Administration (FDA) released briefing documents for an upcoming Gastrointestinal Drugs Advisory Committee meeting scheduled for May 19, 2023 to review Intercept Pharmaceuticals’ liver disease candidate, Obeticholic Acid (OCA).
The briefing documents include concerns by FDA reviewers about the drug’s risk-benefit profile, with the FDA noting, "Trial results for obeticholic acid indicate it causes multiple off-target effects that require multiple risk mitigation strategies with low likelihood of effectiveness."
Shares of Intercept Pharmaceuticals stock were down more than 20% in premarket trading and dropped more than 25% in intraday trading once the market opened on May 17, 2023.
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