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.

GENFIT annonce que Medicare couvrira et remboursera NASHnext®, un test sanguin non invasif développé par Labcorp à partir de sa technologie NIS4®, à compter du 10 août 2026. Le remboursement s'élèvera à environ 252 dollars par test dans le cadre du barème des frais de laboratoire clinique. Cette décision vise à faciliter l'adoption à grande échelle du test, qui identifie les patients atteints de MASH à risque, notamment ceux présentant un prédiabète, un diabète de type 2, une obésité ou une dyslipidémie. GENFIT prévoit que cette couverture ouvre la voie à une future prise en charge par les assureurs privés et génère une deuxième source de revenus récurrents, avec plus de détails attendus à l'automne.

GENFIT announced positive Phase 1b results for its investigational drug GNS561 in combination with a MEK inhibitor in heavily pretreated cholangiocarcinoma patients. The study enrolled 19 patients with advanced KRAS-mutated cholangiocarcinoma who had failed one or two prior lines of standard-of-care therapy, and observed a favorable safety and tolerability profile with no dose-limiting toxicities. Approximately half of patients achieved stable disease at Week 6, including one patient maintaining this status up to Week 30. Based on these findings, GENFIT will expand the Phase 1b study with additional higher-dose cohorts while keeping the Phase 2 initiation on track for the second half of 2026.