A historic milestone achieved by GENFIT
with U.S. FDA Accelerated Approval, and EU Approval as First-in-Class Treatment, of Ipsen’s IQIRVO® (elafibranor) for PBC, a molecule synthesized, for the first time, 20 years ago in Lille, France.
About GENFIT
We are a late-stage biopharmaceutical Company dedicated to improving the lives of patients with rare and life-threatening liver diseases characterized by high unmet medical needs.
We are a pioneer in the discovery and development of drugs targeting liver diseases, with a longstanding history and strong scientific heritage spanning more than two decades. Thanks to our expertise in bringing early-stage assets with high potential to late-stage development and to our strong track record to develop long term collaboration and partnerships, today we boast a growing and diversified pipeline of innovative therapeutic and diagnostic solutions.
We are a world leader in Acute-on-Chronic Liver Failure (ACLF) and its associated medical complications, with five assets in development based on differentiated mechanisms of action leveraging complementary pathways.
Given the high unmet medical need in this indication, some of these programs may qualify for some of the expedited regulatory pathways provided by health authorities
Our Therapeutic Areas
Our R&D pipeline covers targeted therapeutic areas via eight programs across a variety of development stages (preclinical, Phase 1, Phase 2)
- 6 programs in Acute-on-Chronic Liver Failure (ACLF) and Hepatic Encephalopathy (HE), one of the most common complications of ACLF
- 2 programs in Other Life-Threatening Indications: Cholangiocarcinoma (CCA), and Urea Cycle Disorders (UCD)/Organic Acidemias (OA)
Beyond therapeutics, GENFIT’s pipeline also includes a diagnostic franchise focused on NASH/MASH1 and ammonia.
Our Success in PBC
In June 2023, GENFIT and Ipsen announced positive topline 52-week data from the pivotal Phase 3 trial ELATIVE®2 evaluating elafibranor in Primary Biliary Cholangitis (PBC). This asset was discovered and successfully developed by GENFIT. Ipsen is now responsible for regulatory applications and the commercialization of elafibranor, as well as further development and life cycle management.
Our expertise
Our Documentation
Corporate presentation
November 2024
https://ir.genfit.com/static-files/069b79c6-6358-426c-8b59-06226784a333
Half-Year Business and Financial Report
2024 (at June 30 2024)
Latest Press Releases
Our CSR Commitment
We believe that Corporate Social Responsibility (CSR) is a key driver for success. Our positioning in the healthcare sector, at the service of patients, is a central element of our societal commitment, which we complement with proactive social and environmental policies and initiativesdeveloped and carried out by our teams. Our actions are coordinated through a system of corporate governance that meets demanding criteria in terms of ethics, responsibility and fairness.
Nos vidéos
1 At EASL Congress in June 2023 it was announced that nonalcoholic steatohepatitis (NASH) would now be referred to as Metabolic dysfunction-associated steatohepatitis (MASH). Nonalcoholic fatty liver disease (NAFLD) will now be referred to as metabolic dysfunction-associated steatotic liver disease (MASLD). GENFIT is progressively transitioning its documentation over to this new nomenclature and both NASH and MASH terms may appear in our documents during this period
2 GENFIT Communique de presse – 30 juin 2023 : Ipsen et GENFIT annoncent les résultats positifs de l’essai de Phase III ELATIVE® évaluant elafibranor chez des patients atteints de cholangite biliaire primitive, une maladie cholestatique rare du foie