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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...
Intercept Pharma ( NASDAQ: ICPT ) is scheduled to announce Q4 earnings results on Thursday, March 2nd, before market open. The consensus EPS Estimate is -$0.46 (+62.6% Y/Y) and the consensus Revenue Estimate is $78.08M (-15.5% Y/Y). Over the last 1 year, ICPT has beaten EPS ...
MORRISTOWN, N.J., Feb. 27, 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 Jerry Durso, President and Chi...
Intercept Pharmaceuticals ( NASDAQ: ICPT ) and Apotex reached a settlement in regards to patent claims against Apotex over Intercept's rate liver disease treatment Ocaliva. Intercept ticked up 0.7%. The settlement was disclosed in a Delaware court filing on Friday. The settlem...
MORRISTOWN, N.J., Feb. 23, 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 fourth quarter and full-year...
The shares of Intercept Pharmaceuticals ( NASDAQ: ICPT ) added ~8% on Wednesday after the biotech announced an agreement with generic drugmaker Amneal Pharmaceuticals ( NYSE: AMRX ) to settle a patent dispute over the liver disease therapy Ocaliva. The Jan. 24 agreement ai...
Summary Due to what is seemingly a successful comeback, you can expect Intercept Pharmaceuticals to potentially deliver several-fold returns. Ocaliva's revenue for PBC alone is nearly enough to bank a net profit. The FDA recently accepted the New Drug Application of Ocaliva for non-...
Summary FDA has set June 22nd as the action date for its review of Ocaliva in NASH. Approval of Ocaliva in NASH is a long shot. Ocaliva’s growth in Primary Biliary Cholangitis is slowing. Intercept ( ICPT ) just announced that the FDA has set an action date ...
Intercept Pharmaceuticals ( NASDAQ: ICPT ) added ~2% pre-market Thursday after announcing that the FDA accepted its marketing application for obeticholic acid (OCA) as a treatment for pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis (NASH). The regulator has assign...
NDA is supported by robust NASH clinical development program, including two positive interim analyses from the Phase 3 REGENERATE study demonstrating OCA’s improvement in liver fibrosis without worsening of NASH PDUFA target action date set for June 22, 2023 MORRISTOWN, N.J.,...
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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% ...