Intercept Provides Regulatory Update Regarding sNDA for OCALIVA
October 17, 2024 08:59 ET
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Intercept Pharmaceuticals, Inc.
MORRISTOWN, N.J., Oct. 17, 2024 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc., a wholly owned subsidiary of Alfasigma S.p.A., today announced that the U.S. Food and Drug Administration (FDA)...
Company Statement on FDA Advisory Committee Meeting
September 13, 2024 19:40 ET
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Intercept Pharmaceuticals, Inc.
MORRISTOWN, N.J., Sept. 13, 2024 (GLOBE NEWSWIRE) -- The Gastrointestinal Drugs Advisory Committee (GIDAC) of the U.S. Food and Drug Administration (FDA) met today to discuss Intercept’s...
Findings From COBALT Trial, Including External Control Arm, Published in The American Journal of Gastroenterology
September 06, 2024 10:30 ET
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Intercept Pharmaceuticals, Inc.
Analysis compares results from confirmatory trial COBALT in PBC with real-world data from a pre-specified external control group utilizing the Komodo Health U.S. claims database Findings include...
Intercept Presents New Data on the Results of OCA-Bezafibrate Combination Therapy in PBC After Six Months of Treatment in Late-Breaking Poster Presentation at EASL Congress 2024
June 05, 2024 12:00 ET
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Intercept Pharmaceuticals, Inc.
MORRISTOWN, N.J., June 05, 2024 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc., a biopharmaceutical company and wholly owned subsidiary of Alfasigma S.p.A. focused on the development and...
Intercept Presents New Sub-Analyses of Phase 3 POISE Data Showcasing the Effect of OCA on Key Liver Biomarkers in Patients with PBC at EASL Congress 2024
June 04, 2024 11:00 ET
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Intercept Pharmaceuticals, Inc.
MORRISTOWN, N.J., June 04, 2024 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc., a biopharmaceutical company and wholly owned subsidiary of Alfasigma S.p.A. focused on the development and...
Intercept Announces New Data to be Presented at the European Association for the Study of the Liver (EASL) Congress 2024
May 29, 2024 08:00 ET
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Intercept Pharmaceuticals, Inc.
MORRISTOWN, N.J., May 29, 2024 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc., a biopharmaceutical company and wholly owned subsidiary of Alfasigma S.p.A. focused on the development and...
Intercept Presents New Sub-Analyses of Phase 3 POISE Data Showcasing the Effect of OCA on Key Liver Biomarkers and Fibrosis in Patients with PBC at Digestive Disease Week® 2024
May 20, 2024 08:00 ET
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Intercept Pharmaceuticals, Inc.
OCA normalizes levels of ALT and AST, liver biomarkers associated with poor clinical outcomes in a significantly higher proportion of patients after 12 months of treatment compared to placebo;...
Intercept Presents New Data Demonstrating the Impact of OCA-Bezafibrate Combination Therapy on ALP and Metabolic Outcomes After Six Months of Treatment at Digestive Disease Week® 2024
May 18, 2024 08:00 ET
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Intercept Pharmaceuticals, Inc.
Results from a Phase 2 study show combination of OCA 5-10mg and bezafibrate 400mg induced the greatest percent change from baseline in ALP at Month 6 OCA and bezafibrate combination therapy has...
Intercept Announces New PBC Data Analyses to be Presented at Digestive Disease Week® 2024 Conference
May 09, 2024 08:00 ET
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Intercept Pharmaceuticals, Inc.
MORRISTOWN, N.J., May 09, 2024 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc., a biopharmaceutical company and wholly owned subsidiary of Alfasigma S.p.A. focused on the development and...
Intercept Announces FDA Acceptance of Supplemental New Drug Application for Ocaliva® (obeticholic acid) for the Treatment of PBC
February 29, 2024 08:30 ET
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Intercept Pharmaceuticals, Inc.
sNDA intended to satisfy post-marketing requirements to confirm a clinical benefit in patients with PBCPrecedent-setting submission includes data from post-marketing studies COBALT and Study 401 as...