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MORRISTOWN, N.J., April 13, 2023 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, will announce its first quarter 2023 financia...
2023-04-12 12:54:05 ET Summary Intercept Pharmaceuticals markets and sells Ocaliva to patients with primary biliary cholangitis. Sales grew >10% in 2022 and are forecast to grow ~14% in 2023, to ~$325m, but the much larger market opportunity is in non-alcoholic steatohepatitis ...
2023-03-29 23:40:24 ET Summary NASH, or nonalcoholic steatohepatitis, is a liver inflammatory disease that can progress to fibrosis and cirrhosis. NASH is now the second leading cause of liver transplantation, and the US patient population is forecast to increase from 16 million i...
2023-03-22 07:44:35 ET Liver disease drug developer 89bio ( NASDAQ: ETNB ) added ~47% on Wednesday after announcing topline data from its Phase 2b ENLIVEN trial for pegozafermin in patients with nonalcoholic steatohepatitis (NASH). The trial involved 219 patients who wer...
2023-03-10 09:23:14 ET The FDA announced on Friday that a group of independent experts would meet in May to discuss the marketing application for Obeticholic Acid (OCA), a liver disease candidate developed by Intercept Pharmaceuticals ( NASDAQ: ICPT ) for nonalcoholic steatohepa...
Advisory Committee Meeting scheduled for May 19, 2023 PDUFA Target Action Date is June 22, 2023 MORRISTOWN, N.J., March 10, 2023 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT), a biopharmaceutical company focused on the development and commercialization of nove...
MORRISTOWN, N.J., March 09, 2023 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced that it will be participating in i...
Intercept Pharmaceuticals, Inc. (ICPT) Q4 2022 Results Conference Call March 02, 2023 08:30 AM ET Company Participants Nareg Sagherian - Executive Director, Investor Relations Jerry Durso - President and Chief Executive Officer Linda Richardson - Chief Commercial Offic...
Intercept Pharma press release ( NASDAQ: ICPT ): Q4 GAAP EPS of -$0.50 misses by $0.26 . Revenue of $77.22M (+12.5% Y/Y) misses by $0.86M . As of December 31, 2022, Intercept had cash, cash equivalents, restricted cash, and investment debt securities available for sale...
U.S. Ocaliva ® net sales of $77.2 million and $285.7 million for the fourth quarter and full year 2022, representing 13% and 10% growth over the prior year Worldwide Ocaliva ® non-GAAP adjusted net sales of $343.8 million for the full year 2022 As of December 3...
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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 commercialization of novel therapeutics to treat rare and serious liver diseases, today announced five abs...
sNDA intended to satisfy post-marketing requirements to confirm a clinical benefit in patients with PBC Precedent-setting submission includes data from post-marketing studies COBALT and Study 401 as well as real-world evidence from a claims database and patient registries FDA has assign...
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 12 weeks OCA 5 or 5-10 mg + bezafibrate 400 mg cohorts in both studies showed a >60% ...