Company Statement on FDA Advisory Committee Meeting
13 sept. 2024 19h40 HE
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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
06 sept. 2024 10h30 HE
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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
05 juin 2024 12h00 HE
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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
04 juin 2024 11h00 HE
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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
29 mai 2024 08h00 HE
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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
20 mai 2024 08h00 HE
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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
18 mai 2024 08h00 HE
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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
09 mai 2024 08h00 HE
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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
29 févr. 2024 08h30 HE
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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...
Intercept Announces New Phase 2 Data Showing Significant Impact of OCA-Bezafibrate Combination on Normalization of Multiple Key Biomarkers of PBC-Induced Liver Damage at AASLD The Liver Meeting® 2023
13 nov. 2023 08h00 HE
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Intercept Pharmaceuticals, Inc.
Data from two Phase 2 studies in PBC show combination of OCA + bezafibrate achieved biochemical remission (normalization of ALP, total bilirubin, GGT, ALT and AST) in 40-44% of patients in the first...