Inventiva Completes Final Phase 3 Trial Visits for Lanifibranor in MASH Treatment — Inventiva S.A.

Event summary

Inventiva completed the last patient visit in the NATiV3 Phase 3 clinical trial for lanifibranor, treating MASH with moderate and advanced fibrosis.
The trial enrolled 1,009 patients in the main cohort and 410 in the exploratory cohort.
Topline results from NATiV3 are expected in Q4 2026, with potential regulatory submission in H1 2027 and a U.S. launch in 2028 if approved.
Inventiva will participate in three investor conferences in September 2026 and release H1 2026 financial results on September 28, 2026.

The big picture

Inventiva's completion of the NATiV3 Phase 3 trial marks a critical milestone in the development of lanifibranor for MASH treatment. The trial's success could position lanifibranor as a leading therapy in a market with significant unmet needs. The strategic focus on pan-PPAR agonism differentiates lanifibranor from other treatments, potentially offering a broader mechanism of action. The upcoming topline results and regulatory submissions will be key indicators of the drug's commercial potential.

What we're watching

Regulatory Timeline: Whether the topline results from NATiV3 will support a regulatory submission in H1 2027 and a potential U.S. launch in 2028.
Clinical Efficacy: How the long-term safety and efficacy data from the 72-week treatment period will impact the approval process.
Market Positioning: The pace at which Inventiva can position lanifibranor as a leading treatment for MASH if approved.