Genfit S.A. (GNFTY) is a late-stage biopharmaceutical company focused on discovering, developing and advancing therapeutic solutions for patients with rare and life-threatening liver diseases, including acute-on-chronic liver failure (ACLF), acute decompensation (AD), hepatic encephalopathy (HE), cholangiocarcinoma (CCA), urea cycle disorders (UCD) and organic acidemias (OA); its pipeline encompasses eight therapeutic programs across various development stages, including four in ACLF/HE such as G1090N (NTZ reformulation), VS-01 (now refocused on UCD following discontinuation in ACLF), and others targeting key pathophysiological pathways with complementary mechanisms of action, alongside two programs in CCA and UCD/OA; beyond therapeutics, the company maintains a diagnostic franchise in non-alcoholic steatohepatitis (NASH)/metabolic dysfunction-associated steatohepatitis (MASH) and ammonia biomarkers.
Founded in 1999 and headquartered in Lille, France, with additional offices in Paris (France), Zurich (Switzerland) and Cambridge, Massachusetts (USA), Genfit operates primarily in Europe and the United States, targeting high-unmet-need patient populations in rare liver diseases through innovative R&D, clinical expertise, regulatory affairs and data science capabilities.
The company achieved a major milestone with its elafibranor program, discovered and advanced by Genfit, which received accelerated approval as Iqirvo® from the U.S. FDA, EMA and UK MHRA in 2024 for primary biliary cholangitis (PBC), a rare cholestatic liver disease, following positive 52-week Phase 3 ELATIVE® trial results; Iqirvo® is now marketed in several countries by partner Ipsen under an exclusive global licensing and collaboration agreement established in 2021, unlocking milestone payments including €26.5 million upon pricing and reimbursement achievements in 2025.
Recent strategic developments include the completion in March 2025 of a non-dilutive royalty financing agreement with HealthCare Royalty (HCRx) for up to €185 million, featuring a €130 million upfront payment and potential additional €55 million in milestones tied to Ipsen royalties, extending cash runway beyond 2027 and eliminating dilutive convertible debt; in 2025, Genfit attained B Corp™ certification, announced advances in its ACLF pipeline at the AASLD Liver Meeting including new data on G1090N and real-world cirrhosis insights, and refocused VS-01 development on UCD after discontinuing it in ACLF; earlier, the company completed the acquisition of Versantis AG to bolster its pipeline.