ICPT - Intercept stock trading halted ahead of FDA panel meeting for liver disease drug

2023-05-19 07:51:30 ET

• Intercept Pharmaceuticals ( NASDAQ: ICPT ) said Nasdaq has halted trading of its common stock ahead of a U.S. Food and Drug Administration (FDA) panel meeting today to review its liver disease therapy Obeticholic Acid (OCA).
• The FDA's Gastrointestinal Drugs Advisory Committee (GIDAC) is meeting today (Friday) to review OCA as a treatment for pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis (NASH).
• On Wednesday, the company's stock fell (closing -14.68%) after the FDA issued briefing documents in which reviewers raised concerns about the drug's risk-benefit profile. Raymond James also downgraded the stock citing a potential rejection.
• The FDA's advisory committees issue non-binding recommendations but the agency usually considers them while making a final decision.
• The FDA is expected to make a decision by June 22.
• Intercept noted that trading of its stock will resume at Nasdaq's discretion.

• More on Intercept

• Navigating The NASH Storm: Intercept Pharmaceuticals' Uncertain Voyage
• Intercept Pharmaceuticals: Will OCA Win Approval For NASH In June?

For further details see: