GENFIT S.A.

GENFIT S.A. is a biopharmaceutical company headquartered in Loos, France, with additional facilities in Cambridge, MA, USA, and Zurich, Switzerland. The company's mission is to discover and develop therapeutic solutions for rare and life-threatening liver diseases with high unmet medical needs.

GENFIT's pipeline focuses on several severe liver conditions, including Acute-on-Chronic Liver Failure (ACLF), Cholangiocarcinoma (CCA), Urea Cycle Disorders (UCD), and Organic Acidemias (OA). Key therapeutic assets include NTZ (nitazoxanide) for ACLF, SRT-015, CLM-022, VS-02-HE for ACLF/Hepatic Encephalopathy, GNS561 for CCA, and VS-01-HAC for UCD/OA. The company also maintains a diagnostic franchise with NIS2+® for NASH/MASH and TS-01 for blood ammonia levels. Its lead asset, Iqirvo® (elafibranor), discovered and developed by GENFIT, received accelerated approval from the FDA, EMA, and MHRA in 2024 for Primary Biliary Cholangitis (PBC) and is commercialized by Ipsen.

Pascal Prigent has served as CEO since September 2019, with Sakina Sayah-Jeanne appointed Chief Scientific Officer in September 2025. In March 2026, GENFIT received FDA Orphan Drug Designation for NTZ for the treatment of ACLF. The company reported €65.4 million in revenue for 2025, driven by royalties and milestone payments from Iqirvo®, though it recorded a net loss of €86.0 million. Iqirvo® sales by Ipsen exceeded $200 million in its first full year (2025), triggering a $20 million commercial milestone payment to GENFIT. GENFIT became a BCorp™ certified company in 2025. The company voluntarily delisted its American Depositary Shares from the Nasdaq Stock Market in 2025.