ICPT News and Press, Intercept Pharmaceuticals Inc. From 01/19/23

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.,...

Ahead of its presentation at the J.P. Morgan Annual Healthcare Conference, liver drugmaker Intercept Pharmaceuticals ( NASDAQ: ICPT ) pre-announced its financials for 2022 on Wednesday, indicating ~$343M non-GAAP adjusted net sales for the year. New York-based biotech markets Ocaliva ...

MORRISTOWN, N.J., Jan. 05, 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...

MORRISTOWN, N.J., Jan. 04, 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 two abstracts on obeticholic acid (...

Summary Madrigal's lead drug candidate was already expected to be successful in its pivotal trial. FDA approval would then be earned by a positive on one of the trial’s dual endpoints. Because both endpoints were met, something not seen in Phase 3, Madrigal will rule the mark...

Intercept Pharmaceuticals ( NASDAQ: ICPT ) said it resubmitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for obeticholic acid (OCA) to treat patients with pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis (NASH). In...

NDA supported by robust NASH clinical development program, including two positive interim analyses from the Phase 3 REGENERATE study NDA includes detailed safety analysis of 2,477 patients with nearly 1,000 patients on study drug for 4 years MORRISTOWN, N.J., Dec. 23, 2022 (GLOBE ...

Summary The recent Phase 3 (MAESTRO-NAFLD-1) study delivered extremely strong results. This month, Madrigal is expected to release the data for its Phase 3 (MAESTRO-NASH) trial. Depending on the results of the said study, Madrigal shares are either going to rise to a new height or t...

Summary Sage Therapeutics, Inc. completed its rolling submission to the FDA for zuranolone in two indications. Zuranolone is a better formulation of Sage Therapeutics' marketed postpartum drug. However, clinical experience on the major depression side is shaky. ...

MORRISTOWN, N.J., Dec. 08, 2022 (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, is pleased to share that The American Journal of ...