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November 12, 2024 08:00 ET | Source: Intercept Pharmaceuticals, Inc.

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...
October 17, 2024 08:59 ET | Source: Intercept Pharmaceuticals, Inc.

Intercept Provides Regulatory Update Regarding sNDA for OCALIVA

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)...
September 13, 2024 19:40 ET | Source: Intercept Pharmaceuticals, Inc.

Company Statement on FDA Advisory Committee Meeting

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...
September 06, 2024 10:30 ET | Source: Intercept Pharmaceuticals, Inc.

Findings From COBALT Trial, Including External Control Arm, Published in The American Journal of Gastroenterology

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...
June 05, 2024 12:00 ET | Source: Intercept Pharmaceuticals, Inc.

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

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...
June 04, 2024 11:00 ET | Source: Intercept Pharmaceuticals, Inc.

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

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...
May 29, 2024 08:00 ET | Source: Intercept Pharmaceuticals, Inc.

Intercept Announces New Data to be Presented at the European Association for the Study of the Liver (EASL) Congress 2024

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...
May 20, 2024 08:00 ET | Source: Intercept Pharmaceuticals, Inc.

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

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;...
May 18, 2024 08:00 ET | Source: Intercept Pharmaceuticals, Inc.

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

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...
May 09, 2024 08:00 ET | Source: Intercept Pharmaceuticals, Inc.

Intercept Announces New PBC Data Analyses to be Presented at Digestive Disease Week® 2024 Conference

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...