Inventiva Sets Sights on Lanifibranor Approval with Disciplined Clinical and Biostatistical Milestones
In a recent conference call to discuss its full year 2025 financial results and business update, Inventiva's CEO Andrew Obenshain outlined the company's strategy for advancing lanifibranor towards approval for patients with Metabolic Associated Steatohepatitis (MASH).
According to Obenshain, since joining the company six months ago, he has been struck by the depth of scientific conviction behind lanifibranor and the dedication of the team. With a single objective in mind - advancing lanifibranor towards approval for patients with MASH - every resource, decision, and member of the team is now aligned behind this goal.
The company's main focus is its global phase III clinical trial, NATiV3, which was completed in April 2025. The expected timing of top-line readout has been updated to Q4 2026, reflecting the disciplined sequencing of clinical and biostatistical milestones. Obenshain believes that the data from the NATiV3 trial, if positive, has the potential to carry weight with regulators, physicians, and most importantly, patients.
Inventiva made a strategic decision in the first half of 2025 to concentrate all resources on lanifibranor and MASH. As part of this plan, the company sold its global rights to odiparcil to Biosil in Q4 2025, potentially receiving up to $90 million in milestone payments and royalties if approved.
The company has strengthened its leadership team to align with the level of opportunity demanded by lanifibranor's potential approval. Dr. Jason Campagna joined as CMO and President of R&D, Martine Zimmermann as EVP and Head of Quality and Regulatory Affairs, and Nazira Amra as Chief Commercial Strategy Officer.
The opportunity for lanifibranor is real, according to Obenshain. MASH has been underdiagnosed and undertreated for too long, but awareness is growing, screening is improving, and metabolic disease is finally getting the attention it deserves. With an estimated 18 million people in the U.S. living with MASH, only around 10% have been diagnosed, and that number has grown by 25% compared to 2024 estimates.
Among those diagnosed with clinically actionable F2 or F3 disease, only around 40% are currently under the care of a treating physician. If Inventiva's NATiV3 trial can replicate the 18% fibrosis improvement seen in phase II, lanifibranor could be well-positioned as a potential best-in-disease oral therapy with significant commercial impact.
