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Inventiva
Inventiva (IVA) investor relations material
Inventiva Leerink Global Healthcare Conference 2026 summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Leerink Global Healthcare Conference 2026 summary10 Mar, 2026
Program overview and clinical development
Lead asset lanifibranor is a pan-PPAR agonist in phase 3 trials for MASH, with pivotal data expected in the second half of 2024 and a focus on F2/F3 patients.
Phase 3 NATiV3 trial completed enrollment in April 2024, enrolling about 1,000 patients for 18 months, compared to 247 in the earlier phase 2b trial.
Patient population in phase 3 is enriched for diabetics and F3 fibrosis, reflecting real-world disease trends.
GLP-1 therapies, including semaglutide, are allowed as background medications in NATiV3, with stratification by diabetes status and fibrosis stage.
An exploratory cohort of 410 patients, including F4, is being studied for safety and to inform future outcomes studies.
Efficacy and safety insights
Phase 2b data showed 26% NASH resolution and 18% fibrosis improvement at 6 months; expectations are for a deepening effect at 18 months in phase 3.
Lanifibranor is designed to avoid the safety issues of earlier PPARs, with a novel scaffold and blunted PPAR-gamma effects, resulting in less weight gain and fluid retention.
Blinded interim analyses in NATiV3 indicated dropout rates below 30%, meeting investor milestones and suggesting good tolerability.
Non-invasive biomarkers (Pro-C3, MRI-PDFF) and imaging data support histology findings, with expectations for stronger signals at 18 months.
Weight gain is generally muted, with about half of patients gaining no weight and only 10% reporting it as an adverse event in phase 2.
Regulatory and commercial strategy
Accelerated approval is being pursued for F2/F3, with a confirmatory outcomes study planned in F4/portal hypertension patients.
Regulatory alignment with FDA is ongoing, with plans to initiate the outcomes trial by NDA filing and leverage safety data from the exploratory cohort.
Commercialization plans include building a targeted sales force for GI and hepatology, following the model established by peers, with the ability to launch independently.
Patent protection for lanifibranor extends to 2041 based on polymorph patents, despite composition of matter expiring in 2026.
Positive outcomes data from competitors in F4 could validate the surrogate endpoints and benefit the entire field.
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Next Inventiva earnings date
Barclays 28th Annual Global Healthcare Conference11 Mar, 2026
Inventiva
Next Inventiva earnings date
Barclays 28th Annual Global Healthcare Conference11 Mar, 2026
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Frequently asked questions
Inventiva S.A. is a clinical-stage biopharmaceutical company focused on the development of orally administered small molecule therapies for the treatment of serious diseases. The company's research primarily targets conditions related to fibrosis, lysosomal storage disorders, and oncology. Inventiva leverages its proprietary technology platform to identify and develop novel compounds that modulate nuclear receptors, transcription factors, and epigenetic regulation. The company's lead products are developed through strategic collaborations with other pharmaceutical companies, aiming to advance these therapies through clinical trials and regulatory approval. The company is headquartered in Daix, France, and its shares are listed on the Nasdaq.
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