Lanifibranor - (NATiV3)

September 2, 2026: Inventiva (NASDAQ: IVA) said the last patient completed the final 72-week visit in the Phase 3 NATiV3 trial of lanifibranor for non-cirrhotic MASH with moderate to advanced fibrosis. NATiV3 enrolled 1,009 adults with biopsy-proven MASH and F2/F3 fibrosis in the main cohort, plus 410 patients in an exploratory cohort spanning F1-F4 fibrosis.

NATiV3 is a randomized, double-blind, placebo-controlled study testing lanifibranor 800 mg daily and 1200 mg daily, with histologic endpoints including MASH resolution and at least one-stage fibrosis improvement after 72 weeks. Patients could then enter a 48-week open-label extension for longer-term safety.

The key upcoming catalyst is topline NATiV3 results, expected in Q4 2026. If results are favorable, Inventiva said it anticipates a regulatory submission in H1 2027 and is preparing for a potential U.S. launch in 2028, subject to FDA approval.

Separately, the company said it will participate in the Morgan Stanley Global Healthcare Conference on September 15, 2026, and in the Stifel Virtual Cardiometabolic Forum and Jefferies Healthcare C-Suite series on September 30, 2026. Inventiva also moved its H1 2026 financial results update to September 28, 2026.