US Food and Drug Administration (FDA) has granted Priority Review for New Drug Application (NDA) for elafibranor in PBC, and European Medicine Agency (EMA) has also validated the Marketing...
New Drug Application granted priority review with PDUFA date set for June 10, 2024European Medicines Agency (EMA) has also validated the Marketing Authorization Application (MAA) for elafibranor...
ELATIVE® Phase III trial confirms potential for investigational elafibranor as a novel, first-in-class, dual PPAR α,δ agonist for patients with primary biliary cholangitis.Elafibranor demonstrates...
PARIS, FRANCE, 30 June 2023 – Ipsen (Euronext: IPN; ADR: IPSEY) and GENFIT (Nasdaq and Euronext: GNFT) today announced positive topline data from the pivotal ELATIVE Phase III trial. In the trial the efficacy and safety of elafibranor, an investigational dual ?,? PPAR agonist, is being assessed for the treatment of patients with the rare cholestatic liver disease, primary biliary cholangitis (PBC), who have an inadequate response or intolerance to the current standard of care therapy, ursodeoxycholic acid (UDCA).
Trial met primary endpoint with a statistically significant higher percentage of patients achieving a clinically meaningful cholestasis response compared to placeboElafibranor was well tolerated with...
The companies will partner on elafibranor, the once-failed nonalcoholic steatohepatitis (NASH) drug that is going through late-stage tests for primary biliary cholangitis (PBC), according to a Friday statement.
Genfit was hit hard last year when it abandoned a phase 3 nprogramme for elafibranor in non-alcoholic steatohepatitis (NASH), but npledged to press on with the drug in other indications – and now has thenhelp of fellow French pharma group Ipsen.
Ipsen (Euronext: IPN; ADR: IPSEY) and GENFIT (Nasdaq and Euronext: GNFT) have entered into a long-term strategic partnership for global collaboration between the two companies. The agreement gives Ipsen exclusive worldwide* license to develop, manufacture and commercialize GENFIT’s investigational treatment elafibranor, for people living with Primary Biliary Cholangitis (PBC). The partnership also gives Ipsen access to future clinical programs led by GENFIT and combines GENFIT’s scientific expertise and proprietary technologies in liver disease with Ipsen’s development and commercialization capabilities. To underscore the long-term commitment represented by this partnership, Ipsen will also purchase newly issued GENFIT equity representing 8% post-issuance through a €28m investment in GENFIT, becoming one of the largest shareholders.
Lille, France; Cambridge, MA; November 02, 2021 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and chronic liver diseases, today announced that it will be presenting new clinical data on its investigational compound elafibranor at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® 2021 to be held from November 12 to November 15, 2021
Lille, France; Cambridge, M.A.; September 24, 2020 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and liver diseases, today announced the first patient first visit for ELATIVE, the global, pivotal, Phase 3 study evaluating elafibranor in Primary Biliary Cholangitis (PBC).