ICPT

Intercept Pharmaceuticals, Inc.

ICPT

Market cap $795M

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Delisted

ICPT was delisted on the 7th of November, 2023.

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Intercept Pharma withdraws liver disease drug from US market

Intercept Pharmaceuticals said on Thursday it is voluntarily withdrawing its liver disease treatment from the U.S. market following a request from the Food and Drug Administration.

Intercept Pharma withdraws liver disease drug from US market

US FDA says Intercept's drug can cause liver injury in patients without scarring

Intercept Pharmaceuticals' liver disease drug can cause injury to the organ in patients without severe scarring, the U.S. Food and Drug Administration said on Thursday, based on its review of postmarket clinical trial data.

US FDA says Intercept's drug can cause liver injury in patients without scarring

US FDA declines full approval for Intercept's liver disease drug

The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals' liver disease drug, raising questions about its future in the market.

US FDA declines full approval for Intercept's liver disease drug

Intercept Receives Complete Response Letter from FDA Addressing OCALIVA supplemental New Drug Application (sNDA)

MORRISTOWN, N.J., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc., a wholly owned biopharmaceutical subsidiary of Alfasigma S.p.A., today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) that addresses the supplemental New Drug Application (sNDA) for OCALIVA® (obeticholic acid, OCA) seeking full approval for the treatment of indicated patients with primary biliary cholangitis (PBC) – a rare, progressive disease that disproportionally affects women.

Intercept Receives Complete Response Letter from FDA Addressing OCALIVA supplemental New Drug Application (sNDA)

FDA advisers vote against confirmatory data for Intercept's liver disease drug

Independent advisers to the U.S. Food and Drug Administration voted on Friday against confirmatory trial data for Intercept Pharmaceuticals' liver disease drug, putting into question the treatment's future in the U.S. market.

FDA advisers vote against confirmatory data for Intercept's liver disease drug

FDA staff raises efficacy concerns over Intercept's liver disease drug

The U.S. Food and Drug Administration's staff on Wednesday raised concerns over the efficacy of Intercept Pharmaceuticals' liver disease drug, which is awaiting the regulator's traditional approval.

FDA staff raises efficacy concerns over Intercept's liver disease drug

Intercept Announces FDA Acceptance of Supplemental New Drug Application for Ocaliva® (obeticholic acid) for the Treatment of PBC

MORRISTOWN, N.J., Feb. 29, 2024 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc., a biopharmaceutical company and wholly owned subsidiary of Alfasigma S.p.A. focused on the development and commercialization of novel therapeutics to treat rare and serious liver diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for Ocaliva for the treatment of individuals with primary biliary cholangitis (PBC). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 15, 2024. In this communication, the agency informed Intercept that they are planning to hold an Advisory Committee meeting to discuss the application.

Intercept Announces FDA Acceptance of Supplemental New Drug Application for Ocaliva® (obeticholic acid) for the Treatment of PBC

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