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Measures reinforce Company’s ability to drive growth in PBC business and continue developing innovative new medicines Company to discontinue all NASH-related investment and reduce workforce by approximately one third Company anticipates achieving profitability in 2024 ...
Planned interim analysis from the first of two Phase 2 studies shows combination of OCA 5-10 mg + bezafibrate 400 mg normalized a range of biomarkers of PBC (ALP, total bilirubin, GGT, ALT and AST) in 58% of patients at 12 weeks ALP normalized in 75% of patients in the OCA 5-10 mg + bez...
2023-06-22 18:37:40 ET Intercept Pharmaceuticals ( NASDAQ: ICPT ) said it is halting investment its drug development program for nonalcoholic steatohepatitis, or NASH, after receiving negative feedback on its market application for its NASH drug candidate obeticholic acid. The ...
Company to discontinue all NASH-related investment and restructure the Company’s operations to strengthen its focus on rare and serious liver diseases Company anticipates achieving profitability in 2024 as a result of planned actions Conference call scheduled for Fr...
2023-06-12 15:19:02 ET Summary Akero Therapeutics is making strong progress in developing a treatment for NASH, an area of high unmet medical need. The company's lead product candidate has shown promising and highly significant results in Phase 2b trials for NASH, primary and seco...
Interim analysis of ongoing Phase 2 study shows combination of OCA 5-10 mg + bezafibrate 400 mg improved levels of multiple biochemical markers associated with clinical outcomes in PBC including ALP, total bilirubin, ALT, and GGT at 12 weeks OCA 5-10 mg + bezafibrate 400 mg also showed ...
MORRISTOWN, N.J., May 31, 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 inv...
2023-05-30 01:19:54 ET Summary Madrigal Pharmaceuticals' drug, resmetirom, for non-alcoholic fatty liver diseases, received FDA's Breakthrough Therapy designation. The company is now focused on the MAESTRO-NASH-OUTCOMES trial. Madrigal's Q1 2023 financial reports show a decrease i...
2023-05-29 15:00:00 ET The Institute for Clinical and Economic Review (ICER), the influential U.S. drug pricing watchdog, has warned about the affordability of two medications currently undergoing studies for liver disease, nonalcoholic steatohepatitis (NASH). Issuing a so-called access...
2023-05-24 13:17:07 ET Shares of the clinical-stage drugmaker Madrigal Pharmaceuticals (NASDAQ: MDGL) were up by 6.2% on elevated volume as of 12:16 p.m. ET Wednesday. The biotech appears to be benefiting from two key tailwinds. First, a Food and Drug Administration (FDA) panel ...
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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% ...