Genfit S.A.

GENFIT announced it will investigate nangibotide in a Phase 2 clinical trial for the treatment of Acute-on-Chronic Liver Failure, or ACLF, following its acquisition of the late-stage asset in summer 2026. The company expects to initiate a Phase 2a proof-of-concept study in the fourth quarter of 2026, with data readout targeted in 2027, and will disclose more details during The Liver Meeting in Denver in November 2026. Nangibotide has been evaluated in four clinical trials with more than 400 subjects exposed, and post-hoc analyses of Phase 2 trials in septic shock and COVID-19 showed multiple efficacy signals, including a statistically significant reduction in mortality in severe COVID-19 and significant improvements in SOFA score from baseline in septic shock, with no meaningful differences versus placebo in safety outcomes. GENFIT said the existing regulatory and CMC packages for nangibotide are well advanced to support rapid clinical development in ACLF. CEO Pascal Prigent said ACLF represents one of the most significant unmet needs in liver disease and that nangibotide could be a strategic fit for the company's ACLF portfolio.