Genfit

GNFTPhase 3

Loos, FranceFounded 1999genfit.com

GENFIT is a French biopharmaceutical company with a 20+ year history, pioneering research in nuclear receptors and metabolic diseases. Its strategic focus is on advancing elafibranor, a first-in-class PPAR agonist, through late-stage development for PBC and exploring its potential in other liver and metabolic conditions. The company is also commercializing NIS4®, a non-invasive blood-based diagnostic technology for NASH, and maintains a discovery pipeline fueled by its integrated research platform. GENFIT is publicly traded on the Euronext Paris and Nasdaq exchanges.

Market Cap

$240M

Founded

1999

Employees

200-300

Focus

Small Molecules

AI Company Overview

Technology Platform

Expertise in nuclear receptor (PPAR) biology integrated with a multi-omics and biomarker discovery platform for developing therapeutics and non-invasive diagnostics for metabolic and liver diseases.

Pipeline Snapshot

22 drugs in pipeline, 1 in Phase 3

Drug	Indication	Stage
Elafibranor + Placebo	Nonalcoholic Steatohepatitis (NASH) With Fibrosis	Phase 3
Elafibranor 80mg + Elafibranor 120mg	Non Alcoholic Steatohepatitis	Phase 2
GFT505 80mg + Placebo	Insulin Resistance	Phase 2
GFT505 80mg + GFT505 120mg + Placebo	Non-Alcoholic Steatohepatitis (NASH)	Phase 2
GFT505 80mg + Placebo	Impaired Glucose Tolerance	Phase 2

Opportunities

The primary near-term opportunity is the regulatory approval and commercialization of elafibranor for PBC, a significant unmet need.

Concurrently, the global rollout of the NIS4® diagnostic test for NASH screening represents a major commercial opportunity.

Further pipeline expansion through business development in metabolic/liver diseases offers long-term growth.

Risk Factors

Key risks include regulatory rejection or delays for elafibranor in PBC, challenges in building a commercial organization and achieving market uptake, intense competition in both the PBC therapeutic and NASH diagnostic markets, and the ongoing need for capital to fund operations without excessive dilution.

Competitive Landscape

In PBC, GENFIT competes with Intercept's Ocaliva and CymaBay's seladelpar, differentiating elafibranor on its dual PPAR mechanism targeting both disease markers and pruritus. In NASH diagnostics, NIS4® competes with other blood tests (FIB-4, ELF) and imaging, competing on specificity for active NASH with significant fibrosis.