What GENFIT does

GENFIT SA is a late-stage biopharmaceutical company headquartered in Loos, France (near Lille), founded in 1999 by Jean-Fran\u00e7ois Mouney. Listed on Euronext Paris under ticker GNFT (and previously on Nasdaq until a voluntary delisting in November 2025), GENFIT employs 150+ people across offices in Lille and Paris (France), Zurich (Switzerland) and Cambridge, MA (USA). The company focuses exclusively on rare and life-threatening liver diseases where there are few or no approved therapies, and combines in-house drug discovery, clinical development, regulatory affairs and non-invasive diagnostics expertise.

The commercial engine is Iqirvo (elafibranor), an oral dual PPAR \u03b1/\u03b4 agonist discovered and developed internally by GENFIT that received Accelerated Approval from the FDA, EMA and UK MHRA in 2024 for Primary Biliary Cholangitis (PBC) and is commercialized worldwide by Ipsen under a 2021 exclusive licensing deal. Beyond Iqirvo, the R&D portfolio comprises eight programs across multiple stages of development: in ACLF and hepatic encephalopathy, NTZ/G1090N (nitazoxanide reformulation with FDA Orphan Drug Designation), SRT-015 (licensed ASK1 inhibitor), CLM-022 (licensed NLRP3 inflammasome inhibitor) and VS-02-HE (urease inhibitor); in other life-threatening indications, GNS561 (PPT-1 inhibitor for KRAS-mutated cholangiocarcinoma, in Phase 1b/2a) and VS-01-HAC (liposomal platform for hyperammonemic crises in urea cycle disorders, FDA Rare Pediatric Disease designation); and in diagnostics, NIS4/NIS2+ blood-based biomarker algorithms for at-risk NASH/MASH (commercially available via Labcorp as NASHnext) plus a prototype TS-01 point-of-care ammonia device. The portfolio is backed by 1,000+ patents.

GENFIT monetizes primarily through licensing royalties and milestone payments rather than direct sales. FY2025 revenue was \u20ac65.4 million, comprised of \u20ac21.8 million in royalties on Ipsen's $208 million of Iqirvo net sales and \u20ac43.6 million in milestone payments (including a \u20ac17 million performance milestone and a \u20ac26.5 million Italy pricing/reimbursement milestone). Go-to-market is via channel partners: Ipsen for Iqirvo commercialization globally and Labcorp for the NIS4/NASHnext diagnostic. The company held \u20ac101.1 million in cash at year-end 2025 (\u20ac136.1 million as of March 31, 2026 after activating an additional \u20ac30 million HCRx royalty-financing tranche in January 2026), with stated cash runway extending beyond end of 2028 despite an \u20ac86.0 million FY2025 net loss driven in part by a \u20ac46.2 million non-cash impairment tied to the September 2025 discontinuation of the VS-01 ACLF program.

Name

GENFIT

Legal name

GENFIT SA

Website

https://genfit.com

Company type

Public

Founded year

1999

Operating status

Operating

Headcount range

101–250 employees

Short description

GENFIT SA is a France-based, Euronext Paris-listed biopharmaceutical company that develops therapies and diagnostics for rare and life-threatening liver diseases, generating revenue primarily through royalties and milestones from Ipsen's commercialization of Iqirvo (elafibranor) for Primary Biliary Cholangitis.

Ownership category

akta.pro rank

Product category

Liver Disease Biopharmaceuticals

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), In-Vitro Diagnostic Substance Manufacturing (325413), Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Pharmaceutical Preparations (2834), In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Genomic & Multi-Omic Biomarkers (NGS panels, transcriptomics, proteomics, metabolomics) (HLAAAMAJ)

akta.pro secondary industries

Proteomics & Biomarker Analytical Testing (HLAGADAG), Molecular Diagnostics & Genomics Laboratories (HLAFAMAE)

Keywords

• Liver disease therapeutics
• Rare disease biopharmaceuticals
• Non-invasive diagnostics
• Biomarker algorithm testing
• Clinical stage drug development

Headquarters

HQ city

Loos

HQ country

France

HQ region

Europe

Offices6 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales

Revenue model

1. Royalties from Iqirvo Sales: GENFIT receives royalty revenue from Ipsen's sales of Iqirvo (elafibranor) for Primary Biliary Cholangitis. In 2025, royalty revenue was €21.8 million, up from €2.7 million year-over-year.
2. Milestone Payments: One-time payments triggered by clinical, regulatory, or commercial milestones. In 2025, GENFIT received €43.6 million in milestone payments, including a €17 million milestone triggered by Ipsen's strong Iqirvo performance, and a €26.5 million milestone for pricing/reimbursement approval in Italy.
3. Royalty Financing Agreement: GENFIT activated an additional €30 million tranche under its royalty-financing agreement with HCRx in January 2026, extending cash runway beyond end of 2028.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels8 records

Core offering

GENFIT is a biopharmaceutical company that discovers, develops, and commercializes therapeutic drug candidates and non-invasive diagnostic technologies for rare and life-threatening liver diseases. Its commercial offering includes Iqirvo (elafibranor), a dual PPAR α/δ agonist approved for Primary Biliary Cholangitis in 2024 and marketed by Ipsen, plus the NIS4/NIS2+ blood-based diagnostic biomarkers for NASH/MASH identification (commercialized as NASHnext via Labcorp). The development pipeline targets Acute-on-Chronic Liver Failure (ACLF), cholangiocarcinoma, urea cycle disorders, and hepatic encephalopathy through multiple proprietary mechanisms.

Product overview

GENFIT is a biopharmaceutical company focused on rare, life-threatening liver diseases. Its product portfolio comprises therapeutic drug candidates across multiple development stages and a diagnostic franchise. The therapeutic pipeline includes Iqirvo® (elafibranor), a dual PPAR α/δ agonist for Primary Biliary Cholangitis (PBC) now commercialized by Ipsen following FDA/EMA/MHRA approval in 2024, and multiple investigational programs for ACLF and associated conditions: G1090N (NTZ reformulation), SRT-015 (ASK1 inhibitor), CLM-022 (NLRP3 inflammasome inhibitor), and VS-02-HE (urease inhibitor for hepatic encephalopathy), all in preclinical or early clinical stages. The diagnostics franchise includes NIS4® and NIS2+®, non-invasive blood-based biomarker technologies for identifying at-risk NASH/MASH patients (commercially available as NASHnext® via Labcorp), and TS-01, a prototype point-of-care device for blood ammonia measurement. Additional therapeutic programs target cholangiocarcinoma (GNS561 in Phase 1b/2a) and urea cycle disorders (VS-01-HAC in preclinical). The company's pipeline covers eight programs across ACLF, other life-threatening indications, and diagnostics.

Differentiator

Problem solved

Functional benefit

Brands

• NIS4: Non-invasive blood-based molecular diagnostic technology for identifying patients with at-risk NASH/MASH with NAS≥4 and significant fibrosis F≥2
• NIS2+
• TS-01
• Iqirvo

Products and services

• Iqirvo (elafibranor) A dual PPAR α/δ agonist originally discovered and developed by GENFIT for treatment of Primary Biliary Cholangitis (PBC). Received Accelerated Approval from FDA, EMA, and MHRA in 2024 and is commercialized by Ipsen in the US and several European countries under a global licensing agreement.
• NIS4 First-generation blood-based molecular diagnostic technology integrating four NASH/MASH-associated biomarkers (alpha-2-macroglobulin, YKL-40, hemoglobin A1c, miR-34a-5p) through an algorithm to produce a single score for identifying patients with at-risk NASH/MASH. Commercially available as NASHnext via Labcorp.
• NIS2+ Optimized blood-based molecular diagnostic technology demonstrating robust improved clinical performance for efficient identification of at-risk NASH/MASH regardless of patient characteristics such as age, sex, and type 2 diabetes.
• TS-01 Point-of-care diagnostic device based on transmembrane pH-gradient polymersome technology for at-home measurement of ammonia in blood, designed to be fast, selective, and sensitive across a wide range covering physiological and pathological ammonia levels.
• G1090N (NTZ reformulation) A new reformulation of nitazoxanide (NTZ) being developed for Acute-on-Chronic Liver Failure (ACLF), with anti-inflammatory and anti-apoptotic properties targeting gut microbiota and bacterial overgrowth, designed to optimize dose-response and provide dosing flexibility for ACLF patients with renal or hepatic impairment.
• SRT-015 An ASK1 (Apoptosis Signal-Regulating Kinase 1) inhibitor with injectable formulation licensed exclusively worldwide from Seal Rock Therapeutics in May 2023 for acute liver disease including ACLF. Preclinical and clinical evidence supports multi-system benefits including blocking hyper-inflammatory response, reducing ROS-related immune response, reducing apoptosis, and protecting macrophages.
• CLM-022 A first-in-class NLRP3 (nucleotide-binding domain, leucine-rich-containing family, pyrin domain-containing-3) inflammasome inhibitor licensed exclusively worldwide from Celloram Inc. in July 2023 for liver disease applications, showing promise in animal models for reducing liver damage and inflammation.
• VS-02-HE A hydroxamic acid derivative designed as a urease inhibitor to treat Hepatic Encephalopathy (HE), a common complication of ACLF, developed as a unique oral and colon-active formulation designed to minimize systemic absorption of ammonia and reduce glutamine levels in the brain.
• VS-01-HAC A liposomal therapeutic candidate based on proprietary scavenging liposomal technology administered directly into the peritoneal cavity following drainage of ascites, being developed as a potential first-line lifesaving treatment for acute hyperammonemic crises associated with Urea Cycle Disorders (UCD) and Organic Acidemias (OA). Granted Rare Pediatric Disease designation by the FDA.
• GNS561 in CCA A Palmitoyl Protein Thioesterase-1 (PPT-1) inhibitor in-licensed from Genoscience Pharma in 2021 that blocks cancer cell proliferation by inhibiting late-stage autophagy, being evaluated in a Phase 1b/2a trial combined with trametinib for KRAS-mutated cholangiocarcinoma. FDA Orphan Drug Designation obtained.

Quantifiable outcome

• Iqirvo generated $208M in net sales by Ipsen in 2025, triggering $20M milestone payment to GENFIT one year ahead of schedule
• +3 more outcomes

Named customers2 records

Segments6 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability2 records

Feature6 records

Partnerships

Seven partnerships are on record, tiered strategic and core.

• EF CLIFstrategicStrategic or Co-development Partner · 1 January 2026Co-hosting annual ACLF Insights event at EASL Congress 2026. Collaboration on landmark global consensus meeting to forge unified definition of ACLF.
• Celloram Inc.strategicTechnology or Integration · 1 July 2023Exclusive worldwide licensing of CLM-022, a first-in-class NLRP3 inflammasome inhibitor for liver disease applications.
• Seal Rock TherapeuticsstrategicTechnology or Integration · 1 May 2023Exclusive worldwide licensing of SRT-015 (ASK1 inhibitor) for injectable formulation in acute liver disease including ACLF treatment (21 consecutive days or less).
• Versantis AGcoreStrategic or Co-development Partner · 1 September 2022Acquisition completed in 2022 for CHF 40 million upfront (~$41 million) plus up to CHF 65 million in milestones. Swiss clinical-stage biotech focused on liver diseases, bringing VS-01 liposomal technology and VS-02 urease inhibitor programs. Total potential deal value of CHF 105 million.
• IpsencoreChannel Partner/ Reseller/ Distributor · 17 June 2021Exclusive global licensing agreement for elafibranor (Iqirvo) for Primary Biliary Cholangitis. Ipsen commercializes the drug in the US, Europe, and other markets. Ipsen also became an 8% shareholder in GENFIT in 2021. Ipsen initiated the only global Phase 3 trial (ELASCOPE2) for PSC in February 2026.
• LabcorpcoreChannel Partner/ Reseller/ Distributor · 1 January 2021Agreement to commercialize NASHnext, powered by GENFIT's proprietary NIS4 diagnostic technology for identifying at-risk NASH/MASH.
• Genoscience PharmacoreTechnology or Integration · 1 January 2021Exclusive licensing of GNS561 (PPT-1 inhibitor) for cholangiocarcinoma treatment. GNS561 blocks cancer cell proliferation by inhibiting late-stage autophagy.

Scale indicators20 records

Recent moves8 records

Expansion highlights6 records

Emerging players

• 89bio: Clinical-stage biopharma focused on MASH with lead asset pegozafermin (FGF21 analog) in Phase 3. Comparable in therapeutic-area focus and size to GENFIT, with similar specialization in liver metabolic diseases.
• Terns Pharmaceuticals: Clinical-stage biopharma developing oral therapies for MASH and other chronic liver diseases. Overlaps with GENFIT's hepatology and biomarker-based diagnostic positioning, addressing similar fibrotic and metabolic liver indications.
• Pliant Therapeutics: Clinical-stage biopharma focused on integrin-based therapies for fibrotic diseases including liver fibrosis and PSC, intersecting with GENFIT's liver fibrosis and cholestatic disease focus.
• Enyo Pharma: European clinical-stage biopharma developing therapeutics for hepatitis B and acute liver diseases. Comparable in size and European origin to GENFIT, addressing overlapping liver disease therapeutics.

Direct peers

• Inventiva SA: French late-stage clinical biopharmaceutical company developing therapeutics for liver diseases, including lead asset lanifibranor for MASH. Direct fellow French liver-focused biotech comparable in size, stage, and therapeutic-area focus to GENFIT.
• Intercept Pharmaceuticals: Maker of Ocaliva (obeticholic acid), the first FDA-approved therapy for Primary Biliary Cholangitis. Direct competitor to GENFIT's Iqirvo in PBC with similar orphan-liver-disease positioning.
• Madrigal Pharmaceuticals: US biopharma that developed Rezdiffra (resmetirom), the first FDA-approved therapy for MASH with moderate-to-advanced fibrosis. Direct peer in the hepatology space and overlapping biomarker/diagnostic themes relevant to NIS4/NIS2+.

Broad incumbents

• Gilead Sciences: Global biopharmaceutical leader with broad hepatology presence, including recent acquisition of CymaBay Therapeutics (seladelpar for second-line PBC). Competes broadly with GENFIT in liver disease and now markets a direct PBC competitor to Iqirvo.
• Ipsen: Global specialty biopharma that is GENFIT's commercialization partner for Iqirvo and an 8% shareholder. Operates a broader hepatology and rare-disease portfolio (including Albireo) overlapping GENFIT's PBC and ACLF focus.

Others

• BioMarin Pharmaceutical: Independent global rare-disease biopharma with a similar 'small commercial-stage plus specialty pipeline' business model and focus on orphan drug commercialization. Comparable as a strategic model archetype for GENFIT's pursuit of rare-disease and orphan pricing economics.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/genfit_pharma
• YouTubeyoutube.com/@genfit6760/videos
• LinkedInlinkedin.com/company/genfit

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Subsidiaries1 record

Funding overview

Funding rounds9 records

Investors6 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A1 record

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about GENFIT