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NEW YORK, Aug. 03, 2020 (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 second quarter 2020 financial result...
Theratechnologies announces positive report for tesamorelin in NASH Theratechnologies Inc. ( THTX ) announced positive data corroborating the impact of tesamorelin in treating HIV-associated nonalcoholic steatohepatitis. The data has been gleaned from a sub-analysis of the Phase 2 study. T...
A rumor making the rounds says a large activist may be getting involved with Intercept Pharma (NASDAQ: ICPT ) to push for sale. More news on: Intercept Pharmaceuticals, Inc., Stocks on the move, Healthcare stocks news, Read more ...
Introduction: Recent Developments On June 30th, 2020, Galectin Therapeutics ( GALT ) announced the long-awaited commencement of their phase 3 NASH cirrhosis trial, NASH-RX. Recent events highlight the innovative and meaningful design of the NASH-RX trial, data from the NASH-CX trial, and...
Investment Thesis Formulating the launch plans well ahead of the approval, Intercept Pharmaceuticals, Inc. ( ICPT ) caught completely off guard when the FDA refused to sign off OCA, a Intercept’s candidate for liver fibrosis in NASH. The agency, however, hasn’t completely ...
Intercept Pharmaceuticals (NASDAQ: ICPT) fully expected approval from the Food and Drug Administration for obeticholic acid (OCA) in treating non-alcoholic steatohepatitis (NASH). CEO Mark Pruzanski even stated on the company's Q1 conference call last month that the drugmaker would be "prepa...
There's a number of upcoming catalysts in the liver disease treatment space, prompting Needham to update its takes on drugmakers targeting the diseases. More news on: Intercept Pharmaceuticals, Inc., Albireo Pharma, Inc., Mirum Pharmaceuticals, Inc., Healthcare stocks news, Notable Calls ...
Alexion Pharma Receives European Approval for Ultomiris Alexion Pharmaceuticals ( ALXN ) announced that its lead drug candidate Ultomiris has been approved by the European Commission. Ultomiris may now be used for treating adults and children with atypical hemolytic uremic syndrome in Eu...
Gainers: BioHiTech Global (NASDAQ: BHTG ) +62% . More news on: BioHiTech Global, Inc., PDS Biotechnology Corporation, Ideanomics, Inc., Stocks on the move, , Read more ...
Intercept Pharmaceuticals (NASDAQ: ICPT ) -38% on FDA rejection of obeticholic acid in NASH. More news on: Intercept Pharmaceuticals, Inc., Cleveland BioLabs, Inc., China Jo-Jo Drugstores, Inc., Stocks on the move, , Read more ...
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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% ...