RegulationFast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan), Orphan Drug (South Korea), Priority Review (United States), Breakthrough Therapy (United States)

Structure/Sequence

Molecular FormulaC22H24O4S

InChIKeyAFLFKFHDSCQHOL-UHFFFAOYSA-N

CAS Registry824932-88-9

Clinical Trials associated with Elafibranor

NCT07387549

/ Not yet recruitingPhase 3

A Phase III, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis

The purpose of this study is to find out how well and safely elafibranor works compared to placebo in adult participants with Primary sclerosing cholangitis (PSC). PSC is a rare disease that causes inflammation and scarring of the bile ducts in the liver. Over time, this can lead to liver damage and serious health problems, including the need for a liver transplant and death.
In this study, about 350 participants with large duct PSC will take part. Participants will be randomized to receive either elafibranor 120 mg once daily or a placebo (a tablet with no active medicine). The study includes a screening period, an treatment period, and a post-treatment safety follow-up.
During the study, participants will undergo routine clinical assessments, laboratory testing, imaging evaluations, and complete patient-reassessments to evaluate liver disease progression, symptoms, quality of life and safety.
Following the end of treatment, participants will complete a safety follow-up period at approximately four weeks. Participants may withdraw from the study at any time. Each participant may be in the study for several years, as the treatment period will continue until the study reaches enough health events among participants, which is expected to take about 5 years.

Start Date14 Apr 2026

Sponsor / Collaborator

Ipsen SA

NCT06730061

/ Active, not recruitingPhase 3

A Phase III, Open-label, Single Arm Study to Investigate the Efficacy and Safety of Elafibranor 80 mg in Adult Japanese Participants With Primary Biliary Cholangitis (PBC)

The purpose of this study is to find out about the safety and how well the study intervention (elafibranor) works in participants with PBC. The participants in this study will have confirmed PBC with inadequate response or intolerance to UDCA, which is a medication used in the management and treatment of cholestatic liver disease.
PBC is a slowly progressive disease characterised by damage of the bile ducts in the liver, leading to a build-up of bile acids which causes further damage. The liver damage in PBC may lead to scarring (cirrhosis).
PBC may also be associated with multiple symptoms. Many patients with PBC may require a liver transplant or may die if the disease progresses and a liver transplant is not done. In this study all participants will receive a daily dose of elafibranor (the study intervention).
The main aim of this study is to determine if elafibranor reduces alkaline phosphatase (ALP) and total bilirubin levels. High ALP and bilirubin levels in the blood can indicate liver disease.
There will be 4 periods in this study: A screening period (up to 10 weeks) to assess whether the participant can take part. A treatment period (52 weeks) where all eligible participants will receive elafibranor. A variable treatment extension period (2-5 years) from End Of Treatment (EOT) period up to the commercial availability of elafibranor in Japan. A follow-up period (4 weeks) where participants' health will be monitored.
Participants will undergo blood sampling, urine collections, physical examinations, clinical evaluations, electrocardiograms (ECG: recording of the electrical activity of heart), ultrasound examinations (a non-invasive test that passes a probe over skin to look at the bladder, urinary tract, and liver), and Fibroscan® examinations (to measure stiffness of the liver). They will also be asked to fill in questionnaires. Each participant will be in this study for up to approximately 6 years

Start Date16 Jan 2025

Sponsor / Collaborator

Ipsen SA

NCT06383403

/ Active, not recruitingPhase 3

A Phase IIIb Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study to Evaluate the Effect of Elafibranor 80 mg on Normalisation of Alkaline Phosphatase in Adult Participants With Primary Biliary Cholangitis (PBC) and Inadequate Response or Intolerance to Ursodeoxycholic Acid.

The participants in this study will have confirmed PBC with inadequate response or intolerance to Ursodeoxycholic acid (UDCA), which is a medication used in the management and treatment of cholestatic liver disease.
Primary biliary cholangitis is a slowly progressive disease characterised by damage of the bile ducts in the liver, leading to a build-up of bile acids which causes further damage. The liver damage in PBC may lead to scarring (cirrhosis). PBC may also be associated with multiple symptoms.
Many patients with PBC may require a liver transplant or may die if the disease progresses and a liver transplant is not done. This study will compare a daily dose of elafibranor (the study drug) to a daily dose of placebo (a dummy treatment).
The main aim of this study is to determine if elafibranor is better than placebo in reducing ALP levels to a normal value. High ALP levels in the blood can indicate liver disease.
There will be three periods in this study: A screening period (up to 8 weeks) to assess whether the participant can take part; a treatment period (up to 52 weeks) where eligible participants will be grouped as per their blood ALP levels and randomly assigned to either receive elafibranor or placebo, and a follow-up period (4 weeks) where participants' health will be monitored.
Participants will be twice as likely to receive elafibranor than placebo (2:1 ratio).
Participants will undergo blood sampling, urine collections, physical examinations, clinical evaluations, electrocardiograms (ECG: recording of the electrical activity of heart), ultrasound examinations (a noninvasive test that passes a probe over skin to look at the bladder, urinary tract, and liver), and Fibroscan® examinations (a noninvasive test that passes a probe on skin to measure stiffness of the liver).
They will also be asked to fill in questionnaires. Each participant will be in this study for up to 64 weeks (15 months).

Start Date09 Jul 2024

Sponsor / Collaborator

Ipsen SA

100 Clinical Results associated with Elafibranor

100 Translational Medicine associated with Elafibranor

100 Patents (Medical) associated with Elafibranor

140

Literatures (Medical) associated with Elafibranor

01 Jun 2026·CURRENT THERAPEUTIC RESEARCH-CLINICAL AND EXPERIMENTAL

Understanding Pharmacokinetic-Drug Interactions With Drugs Approved by the US Food and Drug Administration in 2024 to Better Manage the Risk of Drug Interactions With Concomitant Medications: A Review of Clinical Data From New Drug Applications

Review

Author: Owens, Katie ; Argon, Sophie ; Yu, Jingjing ; Ragueneau-Majlessi, Isabelle ; Wang, Yan

Objective:

This analysis aimed to provide a mechanistic understanding and an evaluation of the clinical relevance of pharmacokinetic drug-drug interactions (DDIs) associated with drugs approved by the Food and Drug Administration in 2024.

Methods:

Drug metabolism, transport, and absorption-based DDI data available in New Drug Applications (NDAs) of small molecular drugs approved (n = 34) was analyzed. The mechanism and clinical outcome of these interactions were characterized based on in vitro, in silico, and clinical data.

Results:

As objects, 11 drugs were identified as clinical substrates. Of these, 7 drugs were substrates of CYP3A, 3 of CYP2C9, one of CYP1A2, and one of CYP2C8, including the sensitive substrates vanzacaftor (CYP3A) and vorasidenib (CYP1A2). As precipitants, 6 drugs (acoramidis, cefepime/enmetazobactam, givinostat, lazertinib, mavorixafor, and resmetirom) were clinical inhibitors of CYP enzymes (2C8, 2C9, 2D6, 2E1, and 3A), with mavorixafor being a CYP2D6 strong inhibitor. Two drugs (elafibranor and tovorafenib) showed weak induction of CYP3A. Regarding transporter data, 3 drugs were substrates of transporters, including seladelpar (BCRP and OAT3), sulopenem (OAT3), and vadadustat (OAT1/3), and 8 drugs (arimoclomol, danicopan, givinostat, lazertinib, mavorixafor, resmetirom, vadadustat, and vazacaftor/tezacaftor/deutivacaftor) were inhibitors of transporters. All clinical DDIs with AUC changes ≥ 2-fold triggered labeling recommendations. Several DDIs with an AUC change <2 also had labeling recommendations, pertaining most often to the concomitant use of drugs with a narrow therapeutic index.

Conclusions:

Mechanistic DDI insights from newly approved therapies can be extrapolated to inform the management of commonly co-administered drugs, supporting a safer and more effective use of new drug products in the context of polypharmacy.

01 Jan 2026·JOURNAL OF HEPATOLOGY

Safety and efficacy of elafibranor in primary sclerosing cholangitis: The ELMWOOD phase II randomized-controlled trial

Article

Author: Demir, Münevver ; Bonder, Alan ; Jaitly, Seema ; Gilroy, Richard ; Patel, Bhaktasharan C ; Shiffman, Mitchell L ; Bowlus, Christopher L ; Cazzagon, Nora ; Trivedi, Palak J ; Jacobson, Ira M ; Kugelmas, Marcelo ; Ko, Hin Hin ; Olveira, Antonio ; Cheent, Kuldeep ; Turnes, Juan ; Thorburn, Douglas ; Mukhopadhya, Ashis ; Kowdley, Kris V ; Bilir, Bahri M ; Gomes da Silva, Hugo ; Dill, Michael T ; Cortez-Pinto, Helena ; Kallis, Yiannis ; Levy, Cynthia ; Miller, Benjamin ; Pietrangelo, Antonello ; Abouda, George F ; Eksteen, Bertus ; Milligan, Claire ; Pradhan, Faruq ; Luketic, Velimir ; Salcedo, Magdalena ; Montano-Loza, Aldo J ; Mangia, Alessandra ; Sprinzl, Kathrin ; Swann, Rachael ; Zein, Claudia O ; Thuluvath, Paul J ; Chandok, Natasha ; Tavenard, Aude ; Fenkel, Jonathan M ; Campos-Varela, Isabel

BACKGROUND & AIMS:

Primary sclerosing cholangitis (PSC) is a rare, chronic liver disease. Elafibranor, a dual peroxisome proliferator-activated receptor-α/δ agonist, was investigated in the phase II ELMWOOD trial (NCT05627362).

METHODS:

This 12-week, double-blind trial enrolled adults with PSC and alkaline phosphatase (ALP) ≥1.5× the upper limit of normal. The primary endpoint was elafibranor safety vs. placebo. Additional endpoints included relative mean change from baseline in ALP and enhanced liver fibrosis (ELF) score.

RESULTS:

A total of 68 participants (male: 54.4%; mean age: 46.3 years; inflammatory bowel disease: 55.9%) were randomized to elafibranor 80 mg (n = 22), elafibranor 120 mg (n = 23), or placebo (n = 23). At baseline, 70.6% were on ursodeoxycholic acid, 48.5% had ELF scores >9.8, and the mean ALP level was 369.5 U/L. At Week 12, rates of treatment-emergent adverse events (TEAEs) and TEAEs leading to discontinuation in participants on elafibranor 80 mg, 120 mg, and placebo were 68.2%, 78.3%, and 69.6%, and 4.5%, 4.3%, and 8.7%, respectively. Serious TEAEs occurred only in participants on placebo (4.3%). Participants on elafibranor 80 mg and 120 mg had reductions in ALP vs. placebo (least squares mean treatment difference [95% CI]: -35.3% [-49.2, -21.4] and -54.7% [-68.3, -41.0], respectively). ALP normalization occurred only in participants on elafibranor 80 mg (9.1%) and 120 mg (17.4%). The LS mean treatment differences (95% CI) in change from baseline in ELF scores in participants on elafibranor 80 mg and 120 mg vs. placebo were -0.19 (-0.52, +0.15) and -0.28 (-0.62, +0.06), respectively.

CONCLUSIONS:

Elafibranor was well tolerated in people with PSC and associated with greater biochemical improvements over 12 weeks compared with placebo. A greater magnitude of response was observed with elafibranor 120 mg compared with 80 mg.

IMPACT AND IMPLICATIONS:

For people with primary sclerosing cholangitis (PSC), there is a need for a well-tolerated and effective treatment that will enhance quality of life, prevent disease progression, and improve long-term outcomes. Here, we present results from the double-blind period of the phase II ELMWOOD trial in PSC, wherein elafibranor, a peroxisome proliferator-activated receptor-α/δ agonist, demonstrated a favorable safety profile, provided greater biochemical improvements over 12 weeks compared with placebo, and appeared to stabilize markers of fibrosis and improve pruritus. These findings support larger and longer term investigations of elafibranor to explore its therapeutic potential as a treatment for people with PSC.

01 Jan 2026·Innere Medizin (Heidelberg, Germany)

Review

Author: Herta, Toni ; Berg, Thomas

Primary biliary cholangitis (PBC) is a chronic inflammatory, autoimmune-mediated liver disease that progresses to fibrosis and cirrhosis if left untreated. In addition to preventing complications, the management of burdensome symptoms, particularly pruritus, represents a key therapeutic goal. Ursodeoxycholic acid (UDCA) is the established first-line treatment; however, up to 40% of patients show an inadequate response and require second-line treatment. Bezafibrate, a pan-peroxisome proliferator-activated receptor (PPAR) agonist, has long been used off-label as an effective option to improve parameters of cholestasis and relieve pruritus. More recently, two new PPAR agonists, elafibranor (PPAR alpha/delta) and seladelpar (PPAR delta), have received conditional approval in Germany. Both demonstrated strong biochemical efficacy and a favorable safety profile in clinical trials. This article provides a comprehensive update on the diagnostics, risk stratification and treatment of PBC, with a particular focus on the role of novel PPAR agonists in second-line treatment. Practical strategies for the treatment of pruritus are also discussed. The aim is to support guideline-based care and to improve the treatment of patients with PBC through timely treatment adjustment and individualized treatment concepts.

215

News (Medical) associated with Elafibranor

26 Feb 2026

·ir.genfit.com

GENFIT Reports Fourth Quarter 2025 Financial Information and Provides a Corporate Update

Cash and cash equivalents totaled €101.1 million as of December 31, 2025 Revenues amounted to €65.4 million as of December 31, 2025 Ipsen’s strong performance with Iqirvo® in PBC (>$200M net sales in year one) triggered GENFIT’s €17.0 million ($20.0 million) milestone, included in reported revenues, but not yet reflected in the cash position ACLF and CCA programs progressing according to plan Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), February 26, 2026 - GENFIT (Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announces its fourth quarter 2025 revenues and cash position results1 and provides a corporate update. I. Cash position As of December 31, 2025, the Company’s cash and cash equivalents amounted to €101.1 million compared with €81.8 million as of December 31, 2024 and €119.0 million as of September 30, 2025. In 2025, cash utilization is mainly the result of our research and development efforts in our Acute on-Chronic Liver Failure (ACLF) franchise (notably VS-01, NTZ/G1090N, SRT-015, CLM-022, and VS-02 HE), as well as GNS561 in cholangiocarcinoma (CCA). Cash utilization is offset notably by the €26.55 million milestone received in July 2025 (invoiced in May 2025) upon pricing and reimbursement approval of Iqirvo® (elafibranor) in Italy, the third major European country to do so, as part of our long-term strategic partnership with Ipsen (the “Ipsen Agreement”) signed in December 2021. In January 2026, GENFIT exercised its option to receive (and did in fact receive) the second installment of the Royalty Financing agreement totaling €30.0 million. Both this amount, as well as the first commercial milestone of €17.0 million ($20.0 million) that GENFIT will receive as part of the Ipsen Agreement, are not included in cash and cash equivalents as of December 31, 2025. We expect that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements beyond the end of 2028, enabling the Company to further develop its R&D pipeline focused on ACLF and support general corporate purposes. This is based on current assumptions and programs and does not include exceptional events. This estimation assumes (i) our expectation to receive significant future commercial milestone revenue pursuant to the Ipsen Agreement and Ipsen meeting its sales-based thresholds and (ii) drawing down the third and final, optional installment under the Royalty Financing agreement. RevenueRevenues for 2025 amounted to €65.4 million compared to €67.0 million for the same period in 2024. Royalty revenue is entirely attributable to worldwide sales of Iqirvo® (elafibranor), which amounted to $208 million in 2025. Milestone revenue in 2025 is comprised of two milestones: GENFIT’s first commercial milestone of €17.0 million ($20.0 million) after Ipsen’s Iqirvo® exceeded the $200 million threshold in its first full year of net sales, and GENFIT’s milestone of €26.55 million upon pricing and reimbursement approval of Iqirvo® (elafibranor) in Italy, the third major European country to do so. II. Corporate update and program highlights Acute On-Chronic Liver Failure (ACLF) The key highlight for this pipeline segment in the fourth quarter 2025 was the progress of our lead program, G1090N, which generated preliminary Phase 1 data readout showing a safety profile and a robust anti-Inflammatory activity evidenced through functional ex vivo assays on blood samples from study participants and cirrhotic donors. As communicated earlier, GENFIT will engage with regulatory authorities to determine the best approach for progressing to a Phase 2 proof-of-concept in inflammatory conditions such as ACLF, where systemic immune dysregulation is a critical driver of disease progression. Other assets developed to address the unmet medical need in ACLF continued their preclinical evaluation during the fourth quarter of 2025 to fully assess their potential before advancing into clinical development. Cholangiocarcinoma (CCA) The main highlight in this indication in the fourth quarter of 2025 was the highly encouraging early data delivered from the ongoing Phase 1b study evaluating investigational drug GNS561 with a MEK inhibitor (MEKi) in KRAS mutated CCA, positioning this novel combination as a potential new therapeutic approach for difficult-to-treat cancers. Phase 1b dose escalation continues as planned to confirm the activity signal, with new data for next patient cohorts and recommended Phase 2 combination doses expected in the first half of 2026. Phase 2 initiation remains targeted for the second half of 2026. Ipsen’s Iqirvo® (elafibranor) in Primary Biliary Cholangitis (PBC) and Primary Sclerosing Cholangitis (PSC) PBC: Iqirvo®’s net sales for the fourth quarter 2025 amounted to $88 million, bringing full-year 2025 sales to $208 million, triggering the first commercial milestone payment to GENFIT one year ahead of schedule. PSC: Ipsen confirmed the initiation of the first and only global Phase 3 clinical trial, addressing a significant unmet medical need, as no approved therapies currently exist for this severe and progressive disease. PSC represents a substantial untapped market opportunity, comparable in size to second line PBC. Should Iqirvo® ultimately receive regulatory approval for this indication, GENFIT would be eligible for additional milestone payments as well as additional double‑digit royalties. END ABOUT GENFIT GENFIT is a biopharmaceutical company committed to improving the lives of patients with rare, life-threatening liver diseases whose medical needs remain largely unmet. GENFIT is a pioneer in liver disease research and development with a rich history and a solid scientific heritage spanning more than two decades. Today, GENFIT focuses on Acute on-chronic Liver Failure (ACLF) and associated conditions such as acute decompensation (AD) and hepatic encephalopathy (HE). It develops therapeutic assets which have complementary mechanisms of action, selected to address key pathophysiological pathways. GENFIT also targets other serious diseases, such as cholangiocarcinoma (CCA), urea cycle disorders (UCD) and organic acidemia (OA). Its R&D portfolio, covering several stages of development, ensures a constant news flow. GENFIT's expertise in developing high-potential molecules – from early to advanced pre-commercialization stages – culminated in 2024 with the accelerated approval of Iqirvo® (elafibranor) by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom for the treatment of Primary Biliary Cholangitis (PBC). Iqirvo® is now marketed in several countries.2 Beyond therapies, GENFIT also has a diagnostic franchise including NIS2+® for the detection of Metabolic dysfunction-associated steatohepatitis (MASH, formerly known as NASH for non-alcoholic steatohepatitis). GENFIT, a BCorp™ certified company since 2025, is headquartered in Lille, France and has offices in Paris (France), Zurich (Switzerland) and Cambridge, MA (USA). The Company is listed on the Euronext regulated market in Paris, Compartment B (Euronext: GNFT). In 2021, Ipsen became one of GENFIT's largest shareholders, acquiring an 8% stake in the Company's capital. www.genfit.com FORWARD LOOKING STATEMENTS This press release contains certain forward-looking statements with respect to GENFIT, including, but not limited to, statements about the Company’s cash runway and the development of its clinical and preclinical programs, to the timelines for obtaining results from ongoing studies and initiating upcoming studies, to upcoming discussions with regulatory authorities, to the potential regulatory approval of its product candidates, and to the projected sales of Iqirvo® in PSC should it be approved for this indication. The use of certain words, such as "believe", "potential", "expect", “target”, “may”, “will”, "should", "could", "if" and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on the current expectations and reasonable assumptions of the Company’s management, these forward-looking statements are subject to numerous known and unknown risks and uncertainties, which could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking statements. These risks and uncertainties include, among others, the uncertainties inherent in research and development, including in relation to non-clinical and pre-clinical programs, reproducibility of preclinical results, the translation of animal model data to human biology, in relation to safety of drug candidates, cost of, progression of, and results from, our ongoing and planned clinical trials, patient recruitment, review and approvals by regulatory authorities in the United States, Europe and worldwide, of our drug and diagnostic candidates, pricing, approval and commercial success of elafibranor in the relevant jurisdictions, exchange rate fluctuations, and our continued ability to raise capital to fund our development, as well as those risks and uncertainties discussed or identified in the Company’s public filings with the AMF, including those listed in Chapter 2 "Risk Factors and Internal Control" of the Company's 2024 Universal Registration Document filed on April 29, 2025 (no. 25-0331) with the Autorité des marchés financiers ("AMF"), which is available on GENFIT's website (www.genfit.fr) and the AMF's website (www.amf.org), and those discussed in the public documents and reports filed with the U.S. Securities and Exchange Commission ("SEC"), including the Company’s 2024 Annual Report on Form 20-F filed with the SEC on April 29, 2025 and subsequent filings and reports filed with the AMF or SEC or otherwise made public, by the Company. In addition, even if the results, performance, financial position and liquidity of the Company and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. These forward-looking statements speak only as of the date of publication of this press release. Other than as required by applicable law, the Company does not undertake any obligation to update or revise any forward-looking information or statements, whether as a result of new information, future events or otherwise. CONTACTS GENFIT | InvestorsJean-Christophe Marcoux – Chief Corporate Affairs Officer | Tel: +33 3 2016 4000 | jean-christophe.marcoux@genfit.com GENFIT | MediaBruno ARABIAN – Agence Maarc | Tel : 06 87 88 47 26 | bruno.arabian@maarc.fr Stephanie Boyer – Press relations | Tel: +333 2016 4000 | stephanie.boyer@genfit.com GENFIT | 885 Avenue Eugène Avinée, 59120 Loos - FRANCE | +333 2016 4000 | www.genfit.com 1 Unaudited financial information under IFRS2 Elafibranor is marketed and commercialized, notably in the U.S and Europe, by Ipsen under the trademark Iqirvo® Attachment GENFIT Reports Fourth Quarter 2025 Financial Information and Provides a Corporate Update

Phase 2Phase 1Financial StatementLicense out/inAcquisition

19 Feb 2026

·www.prnewswire.com

Devonian Reports Human Liver-on-a-Chip Data Demonstrating Disease-Relevant Modulation of MASH by Thykamine™, with Dose-Dependent Anti-Fibrotic and Anti-Inflammatory Effects

QUEBEC, Feb. 19, 2026 /PRNewswire/ - Devonian Health Group Inc. ("Devonian" or the Company) (TSXV: GSD) (OTCQB: DVHGF) today announced positive results from a follow-up preclinical study evaluating Thykamine™ in a human metabolic-associated steatohepatitis (MASH) model using PhysioMimix® Liver-on-a-Chip platform. The study was conducted by CN Bio Innovations, Cambridge, UK. Importantly, the study demonstrates that Thykamine™ exerts dose-dependent effects on key pathological hallmarks of MASH, including fibrosis and inflammation, in a physiologically relevant human liver system. These results represent a critical translational bridge between Devonian's previously disclosed efficacy in the mouse STAM® MASH model and a predictive human microphysiological model. Study Design and Dosing Thykamine™ was evaluated at four low concentrations (0.025, 0.05, 0.1, and 0.2 mg/mL) over a 14-day treatment period in a dynamic, triple-cell liver model incorporating primary human hepatocytes, Kupffer cells, and hepatic stellate cells under continuous microfluidic flow to induce a MASH phenotype. Elafibranor, a clinically advanced compound previously evaluated in MASH clinical trials3,4, was included as a reference positive control (20 uM), alongside a vehicle control. Key Findings Demonstrating Impact on the MASH Phenotype Disease-relevant reduction in fibrosis: Thykamine™ produced a clear, dose-dependent reduction in fibrosis-associated biomarkers, including pro-collagen and TIMP-1, with the strongest effects observed at 0.1 and 0.2 mg/mL. These markers are central to extracellular matrix deposition and fibrotic progression in MASH. Suppression of collagen accumulation: Confocal imaging confirmed a significant decrease in Type I collagen deposition, indicating attenuation of one of the core structural features of fibrotic MASH. At higher doses, the magnitude of collagen reduction was greater than that observed with Elafibranor under identical experimental conditions. Modulation of inflammatory signaling: Thykamine™ induced a dose-dependent reduction in pro-inflammatory cytokines IL-6 and IL-8 at later time points, reflecting an effect on inflammatory pathways that contribute to hepatocellular injury and disease progression in MASH. Preservation of liver cell health: LDH levels remained low throughout the study, with no evidence of drug-induced liver injury. Observed changes in albumin production were not associated with cytotoxicity and will be further investigated. "These findings show that Thykamine™ does more than modulate individual biomarkers—it impacts the core biological processes that define MASH, including fibrosis and inflammation," said Dr. André P. Boulet, PhD, Chief Executive Officer of Devonian. "Together with our previously reported mouse STAM® data, this study strengthens the translational rationale for Thykamine™ as a potential disease-modifying therapeutic candidate" added Dr Boulet. The PhysioMimix® Liver-on-a-Chip platform recapitulates key aspects of human MASH pathology by combining multi-cellular liver architecture with physiological flow. The consistent activity of Thykamine™ across in vivo and human organ-on-a-chip models supports its differentiated profile among emerging MASH therapeutics. Devonian plans to advance additional preclinical studies to further characterize Thykamine™'s disease-modifying potential and support continued development in MASH and other fibrotic diseases. About NAFLD/MASH1,2 Nonalcoholic fatty liver disease (NAFLD) is the most common form of chronic liver disease with a worldwide prevalence of 20-30%. It is represented by fat accumulation in the liver, a condition that is commonly associated with features of the metabolic syndrome (MetS), such as obesity, type 2 diabetes, dyslipidemia, and hypertension. NAFLD progresses to metabolic dysfunction-associated steatohepatitis (MASH), the hallmarks of which are inflammation, hepatocellular ballooning, and subsequent worsening fibrosis. Left untreated, MASH can ultimately progress to cirrhosis of the liver and hepatocellular carcinoma, liver failure and death. The global Metabolic Dysfunction-Associated Steatohepatitis (MASH) treatment market is experiencing rapid growth, driven by rising rates of obesity, type 2 diabetes, and metabolic syndrome5. According to DataM Intelligence6, the market was valued at $7.87 billion in 2024 and is projected to reach $31.76 billion by 2033, growing at a 17.7% CAGR from 2025 to 2033. About Thykamine™ Thykamine™, the first pharmaceutical product issued from Devonian's SUPREX™ platform, is a highly innovative product for the prevention and treatment of health conditions related to inflammation and oxidative stress including ulcerative colitis, atopic dermatitis, psoriasis, rheumatoid arthritis, and other autoimmune disorders. The anti-inflammatory, anti-oxidative and immunomodulatory properties of Thykamine™ have been demonstrated by a considerable number of in vitro and in vivo studies as well as in a Phase IIa clinical study in patients with mild-to-moderate distal ulcerative colitis and in a large Phase II study in adult patients with mild-to-moderate Atopic Dermatitis. Both Thykamine™ and SUPREX™ platform are covered by patents issued in several North American, European and Asian countries. About CN Bio CN Bio is on a mission to accelerate drug discovery. As a leading Organ-on-chip (OOC) company, the team is transforming how human-specific efficacy and safety data are generated. CN Bio's human organ models deepen the understanding of disease mechanisms, help uncover new drug targets and enable development of novel, safe, and effective therapeutics. The Company's portfolio of products and services offer deeper and more valuable insights into how drugs are predicted to perform in patients to greatly reduce risk, time and costs. Based in Cambridge (UK), CN Bio leverages over a decade of experience and expertise in bringing single and multi-organ OOC based microphysiological systems (MPS) to the market. The Company's ground-breaking benchtop PhysioMimix® Core System accurately mimics human physiology using advanced, predictive in vitro human organ models, relieving dependence on animals in line with regulatory change. The power of PhysioMimix® technology has been harnessed by 16 leading pharmaceutical companies and is recognized by the US FDA, resulting in the first co-publication between a drug regulator and MPS provider, plus acceptance into the FDA's ISTAND program. PhysioMimix data has informed several regulatory filings, including a regulatory world first in 2023 when the Company supported a successful filing to initiate clinical testing for the treatment of metabolic liver disease. To find out more about how CN Bio is pioneering faster, more accurate drug discovery, please visit: or follow the company on LinkedIn @CN Bio. About Devonian Devonian Health Group Inc. is a clinical stage pharmaceutical company specializing in the development of drugs for various auto-immune fibroinflammatory disease with novel therapeutic approaches to targeting unmet medical needs. Devonian's core strategy is to develop prescription drugs for the treatment of fibroinflammatory autoimmune diseases including but not limited to atopic dermatitis, radiodermatitis and ulcerative colitis. Devonian is also involved in the development of high-value cosmeceutical products leveraging the same proprietary approach employed with their pharmaceutical offerings. Devonian also owns a commercialization subsidiary, Altius Healthcare LP, focused on selling prescription pharmaceutical products in Canada, under licenses from brand name pharmaceutical companies. Devonian Health Group Inc. was incorporated in 2015 and is headquartered in Quebec, Canada where it owns a state-of-the art extraction facility. Devonian is traded publicly on the TSX Venture Exchange (the " Exchange") ( TSXV: GSD) and currently quoted on the OTCQB Venture Market ( OTCQB: DVHGF). For more information, visit . References Ekstedt M, Nasr P and Kechagias S. Natural History of NAFLD/NASH. Curr Hepatology Rep. 16:391-397, 2017. Pierantonelli I. and Svegliati-Baroni G. Nonalcoholic Fatty Liver Disease: basic Pathogerenic Mechanisms in the Progression from NAFLD to NASH. Transplantation, 103(1): p e1-e13, 2019. Ewsome PN and Loomba R. Therapeutic horizons in metabolic dysfunction–associated steatohepatitis. J Clin Invest.135(13):e186425; 2025. GENFIT: Announces Results from Interim Analysis of RESOLVE-IT Phase 3 Trial of Elafibranor in Adults with NASH and Fibrosis, May 11, 2020 Jeffrey V. Lazarus JV, Brennan PN,Mark HE, et al. A call for doubling the diagnostic rate of at-risk metabolic dysfunction-associated steatohepatitis.The Lancet Regional Health – Europe, 54:101320, 2025. NASH/MASH Treatment Market Size, Share, Growth Insights and Forecast 2025-2033. DataM Intelligence, November 2025. Cautionary Note Regarding Forward-Looking Statements All statements, other than statements of historical fact, contained in this press release including, but not limited to those relating to the Common Shares consolidation; the anticipated post-consolidation trading price of the Common Shares; the potential impact of the consolidation on investor interest and liquidity; the ability to satisfy minimum price or other listing requirements of U.S and other stock exchanges; the impacts in perceived trading price following the consolidation; the ability of the Company to maintain compliance with regulatory requirements following the consolidation; and generally, the above "About Devonian" paragraph, all of which essentially describes the Company's outlook, constitute "forward-looking information" or "forward-looking statements" within the meaning of certain securities laws (collectively, "forward-looking statements"), and are based on expectations, estimates and projections as of the time of this press release. Such forward-looking statements may be identified by the use of words such as "intends", "believes", "expects", or variations (including negative and grammatical variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", or "will" be taken, occur or be achieved. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Company as of the time of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies. These estimates and assumptions may prove to be incorrect. Many of these uncertainties and contingencies can directly or indirectly affect, and could cause, actual results to differ materially from those expressed or implied in any forward-looking statements. There can be no assurance that these assumptions will prove to be correct and there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific, and risks exist that estimates, forecasts, projections and other forward-looking statements will not be achieved or that assumptions do not reflect future experience. Forward-looking statements are provided for the purpose of providing information about management's expectations and plans relating to the future. Readers are cautioned not to place undue reliance on these forward-looking statements as a number of important risk factors and future events could cause the actual outcomes to differ materially from the beliefs, plans, objectives, expectations, anticipations, estimates, assumptions and intentions expressed in such forward-looking statements. All of the forward-looking statements made in this press release are qualified by these cautionary statements and those made in our other filings with the applicable securities regulators of Canada. The Company disclaims any intention or obligation to update or revise any forward-looking statements or to explain any material difference between subsequent actual events and such forward-looking statements, except to the extent required by applicable law. Neither the Exchange nor its Regulation Services Provider (as that term is defined in policies of the Exchange) accepts responsibility for the adequacy or accuracy of this release. SOURCE Devonian Health Group Inc. 21% more press release views with Request a Demo

Phase 2Phase 3Clinical Result

12 Feb 2026

·www.biospace.com

GENFIT to receive US$20M milestone after Ipsen’s Iqirvo® exceeds the US$200M threshold in its first full year of net sales

Ipsen reported US$88M of Iqirvo® net sales in PBC for 4Q25, bringing 2025 sales to US$208M, triggering the first commercial milestone payment to GENFIT ahead of schedule 1 Ipsen confirmed its commitment to launch a Phase 3 in PSC, creating a new avenue for potential future upside for GENFIT GENFIT’s CCA Phase 1b study progressing as planned: New dose-escalation cohort fully enrolled with no dose-limiting toxicities reported at the 21-day timepoint Phase 1b data readout and recommended Phase 2 doses remain on track for 1H26 Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), February 12, 2026 - GENFIT (Euronext: GNFT) , a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced that the strong commercial performance of Iqirvo® in its first full year on the primary biliary cholangitis (PBC) market has triggered a US$20M milestone payment from Ipsen under the companies’ licensing agreement. The commercial success of Iqirvo® in 2025 underscores the strength of our partnership with Ipsen and exceeded our initial expectations with first-year net sales reaching US$208M. This performance activated a US$20M milestone payment ahead of plan, reinforcing GENFIT’s financial position. This momentum also led to the receipt of an additional €30M tranche under GENFIT’s royalty‑financing agreement with HCRx, enhancing financial flexibility in a non-dilutive way. In parallel, Ipsen confirmed the initiation of the first and only global Phase 3 clinical trial in primary sclerosing cholangitis (PSC), addressing a significant unmet medical need, as no approved therapies currently exist for this severe and progressive disease. PSC represents a substantial untapped market opportunity, comparable in size to second line PBC. Should Iqirvo® ultimately receive regulatory approval for this indication, GENFIT would be eligible for additional milestone payments as well as additional double‑digit royalties. Beyond Iqirvo®, GENFIT continues to advance its oncology program. The ongoing Phase 1b study in cholangiocarcinoma (CCA), evaluating GNS561 in combination with a MEK inhibitor, is progressing in line with expectations. As communicated in December 2025, early positive activity was observed in the first evaluable patients at Week 6. Enrollment for a the next escalated-dose cohort has now been completed, with no dose-limiting toxicities (DLTs) reported to date. Recruitment for the following one will now proceed, consistent with the predefined dose‑escalation process. Multi-cohort readouts on safety, tolerability and activity along with the determination of the recommended Phase 2 doses remain expected by the end of the first half of 2026. Pascal Prigent, CEO of GENFIT declared: “We are pleased with Ipsen’s continued success with Iqirvo®. Net sales have surpassed US$200M in 2025 and this remarkable performance has allowed us to get the first commercial milestone a year earlier than anticipated. We believe that this commercial trajectory has the potential to be transformative for our business model. We are also pleased with the progress of our GNS561 program, with a new cohort fully recruited. This program might bring significant hope for patients with a devastating disease, and we are eagerly awaiting new data. As we are also anticipating the first ACLF patients to be included in a phase 2 evaluating G1090N in the second half of the year we believe 2026 will be a landmark year for GENFIT.” GENFIT will publish its 4Q25 revenue and cash position on February 26, 2026. All details from Ipsen’s communication are available here: END ABOUT GENFIT GENFIT is a biopharmaceutical company committed to improving the lives of patients with rare, life-threatening liver diseases whose medical needs remain largely unmet. GENFIT is a pioneer in liver disease research and development with a rich history and a solid scientific heritage spanning more than two decades. Today, GENFIT focuses on Acute on-chronic Liver Failure (ACLF) and associated conditions such as acute decompensation (AD) and hepatic encephalopathy (HE). It develops therapeutic assets which have complementary mechanisms of action, selected to address key pathophysiological pathways. GENFIT also targets other serious diseases, such as cholangiocarcinoma (CCA), urea cycle disorders (UCD) and organic acidemia (OA). Its R&D portfolio, covering several stages of development, ensures a constant news flow. GENFIT's expertise in developing high-potential molecules – from early to advanced pre-commercialization stages – culminated in 2024 with the accelerated approval of Iqirvo® (elafibranor) by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom for the treatment of Primary Biliary Cholangitis (PBC). Iqirvo® is now marketed in several countries. 2 Beyond therapies, GENFIT also has a diagnostic franchise including NIS2+® for the detection of Metabolic dysfunction-associated steatohepatitis (MASH, formerly known as NASH for non-alcoholic steatohepatitis). GENFIT, a BCorp™ certified company since 2025, is headquartered in Lille, France and has offices in Paris (France), Zurich (Switzerland) and Cambridge, MA (USA). The Company is listed on the Euronext regulated market in Paris, Compartment B (Euronext: GNFT). In 2021, Ipsen became one of GENFIT's largest shareholders, acquiring an 8% stake in the Company's capital. FORWARD LOOKING STATEMENTS This press release contains certain forward-looking statements with respect to GENFIT, including, but not limited to, statements about the future commercial trajectory of Iqirvo® in PBC, the ability to obtain marketing authorization for elafibranor in PSC, the potential to receive future milestone payments and royalties under the Ipsen agreement, the timing, progression and expected data readouts of GENFIT’s ongoing clinical programs such as the Phase 1b study in cholangiocarcinoma and the planned Phase 2 study of G1090N in ACLF, and more generally GENFIT’s expectations regarding its financial position, strategic outlook and prospects for 2026 and beyond. The use of certain words, such as "believe", "potential", "expect", “target”, “may”, “will”, "should", "could", "if" and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on the current expectations and reasonable assumptions of the Company’s management, these forward-looking statements are subject to numerous known and unknown risks and uncertainties, which could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking statements. These risks and uncertainties include, among others, the uncertainties inherent in research and development, including in relation to non-clinical and pre-clinical programs, reproducibility of preclinical results, the translation of animal model data to human biology, in relation to safety of drug candidates, cost of, progression of, and results from, our ongoing and planned clinical trials, patient recruitment, review and approvals by regulatory authorities in the United States, Europe and worldwide, of our drug and diagnostic candidates, pricing, approval and commercial success of elafibranor in the relevant jurisdictions, exchange rate fluctuations, and our continued ability to raise capital to fund our development, as well as those risks and uncertainties discussed or identified in the Company’s public filings with the AMF, including those listed in Chapter 2 "Risk Factors and Internal Control" of the Company's 2024 Universal Registration Document filed on April 29, 2025 (no. 25-0331) with the Autorité des marchés financiers ("AMF"), which is available on GENFIT's website ( ) and the AMF's website ( ), and those discussed in the public documents and reports filed with the U.S. Securities and Exchange Commission ("SEC"), including the Company’s 2024 Annual Report on Form 20-F filed with the SEC on April 29, 2025 and subsequent filings and reports filed with the AMF or SEC, including the Half-Year Business and Financial Report at June 30, 2025, or otherwise made public, by the Company. In addition, even if the results, performance, financial position and liquidity of the Company and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. These forward-looking statements speak only as of the date of publication of this press release. Other than as required by applicable law, the Company does not undertake any obligation to update or revise any forward-looking information or statements, whether as a result of new information, future events or otherwise. CONTACTS GENFIT | Investors Jean-Christophe Marcoux – Chief Corporate Affairs Officer | Tel: +33 3 2016 4000 | jean-christophe.marcoux@genfit.com GENFIT | Media Bruno Arabian – Agence Maarc | Tel : 06 87 88 47 26 | bruno.arabian@maarc.fr Stephanie Boyer – Press relations | Tel: +333 2016 4000 | stephanie.boyer@genfit.com GENFIT | 885 Avenue Eugène Avinée, 59120 Loos - FRANCE | +333 2016 4000 | 1 Based on contractual change rates (€76,6M sales in 4Q25 and €184M annual sales in 2025) 2 Elafibranor is marketed and commercialized, notably in the U.S and Europe, by Ipsen under the trademark Iqirvo® . Attachment GENFIT to receive US$20M milestone after Ipsen’s Iqirvo® exceeds the US$200M threshold in its first full year of net sales

Phase 2Phase 1Drug ApprovalLicense out/in

100 Deals associated with Elafibranor

External Link

KEGG	Wiki	ATC	Drug Bank
D11208	Elafibranor	-	DB05187

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Primary Biliary Cholangitis	United States	Ipsen Biopharmaceuticals, Inc.	10 Jun 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Cholangitis, Sclerosing	Phase 3	-	Ipsen SA	14 Apr 2026
Fibrosis	Phase 3	Belgium	Genfit SA	25 Feb 2016
Metabolic Dysfunction Associated Steatohepatitis	Phase 3	Belgium	Genfit SA	25 Feb 2016
liver function failure	Phase 2	Germany	Ipsen Bioscience, Inc.	18 Jan 2023
Metabolic dysfunction-associated steatotic liver disease	Phase 2	Netherlands	Genfit SA	16 Aug 2019
Liver Injury	Phase 2	Belgium	Genfit SA	11 Sep 2012
Insulin Resistance	Phase 2	France	Genfit SA	21 Dec 2010
Diabetes Mellitus, Type 2	Phase 2	Bosnia and Herzegovina	Genfit SA	01 Dec 2010
Diabetes Mellitus, Type 2	Phase 2	Latvia	Genfit SA	01 Dec 2010
Diabetes Mellitus, Type 2	Phase 2	Moldova	Genfit SA	01 Dec 2010

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05627362 (ELMWOOD, Pubmed \| J Hepatol)	Phase 2	Cholangitis, Sclerosing alkaline phosphatase (ALP)	68	Elafibranor 80 mg	zciwxhjlbt(wmxunbuqra) = yrgokthfsm ldotqvjffp (qozoxavuny ) View more	Positive	01 May 2025
				Elafibranor 120 mg	zciwxhjlbt(wmxunbuqra) = bkmdnzafde ldotqvjffp (qozoxavuny ) View more
NCT05627362 (ELMWOOD, NEWS) Manual	Phase 2	Cholangitis, Sclerosing	68	elafibranor	guxzxfvbyx(fzfvmgwvpt) = Data from ELMWOOD demonstrated a positive safety and tolerability profile. mwqykjabpy (zwavxhqceu ) View more	Positive	25 Apr 2025
				Placebo
NCT04526665 (ELATIVE, CTgov)	Phase 3	Primary Biliary Cholangitis	161	Placebo	gpsxzehpph = litqbgulvd fzmqivmxsu (rhuidbwfqj, uurwizfbgi - ogloegyqfv) View more	-	05 Sep 2024
NCT04526665 (FDA_CDER) Manual	Phase 3	Primary Biliary Cholangitis	161	IQIRVO 80mg Once Daily	bgavopjfth(apbmegzcwg) = ghctcqtsgu naaothivcp (xtaumflvvm ) View more	Positive	10 Jun 2024
				Placebo	bgavopjfth(apbmegzcwg) = ohbcswpyxv naaothivcp (xtaumflvvm ) View more
NCT04526665 (ELATIVE, EASL2024) Manual	Phase 3	Primary Biliary Cholangitis	161	Elafibranor	rcwxythybn(vdrzavfbsk) = qjynbpdcyg uinzelppkm (qiwazbubno ) View more	Positive	01 Jun 2024
				Placebo	zpmgyxcqzo(bgrocirgry) = qqnfdidxyt kkvmonlrsm (bnsdsxmuqg )
NCT04526665 (ELATIVE, Pubmed) Manual	Phase 3	Primary Biliary Cholangitis	161	Elafibranor 80 mg	dyzclyrnec(mnaebwoqbm) = nqnypiqsat bxgwvgphtr (ianrymzfxa ) View more	Positive	29 Feb 2024
				Placebo	dyzclyrnec(mnaebwoqbm) = gtaemncrvp bxgwvgphtr (ianrymzfxa ) View more
NEWS Manual	Phase 3	Primary Biliary Cholangitis	161	elafibranor	zebcqhiwws(zchgadfixf): 3.0 View more	Positive	14 Nov 2023
				placebo
NCT04526665 (ELATIVE, Biospace) Manual	Phase 3	Primary Biliary Cholangitis	161	elafibranor 80mg	xanfrkrmpc(ymzuscgudu) = kepounsqfu seubiictib (jyntoykwzw )	Positive	20 Sep 2023
				placebo	xanfrkrmpc(ymzuscgudu) = bqahppzhpe seubiictib (jyntoykwzw )
NCT03883607 (Open Label, Randomized, Multicenter Study of Elafibranor in Children With Nonalcoholic Steatohepatitis, Pubmed \| J Pediatr Gastroenterol Nutr)	Phase 2	Metabolic Dysfunction Associated Steatohepatitis alanine aminotransferase (ALT)	-	Elafibranor 80 mg	fojwlojtcd(zqendulire) = ksscdmbcny gwcoxenmrt (yciqdkkzcj, 13)	Positive	01 Aug 2023
				Elafibranor 120 mg	fojwlojtcd(zqendulire) = yulfiokiub gwcoxenmrt (yciqdkkzcj, 20)
NCT01694849 (CTgov)	Phase 2	Metabolic Dysfunction Associated Steatohepatitis	275	GFT505 80mg (GFT505 80mg)	qbzjgduznq(idbnmbmeij) = nohsgppcfz lhmiupscta (xkmfwosapg, 1.33) View more	-	03 Nov 2022
				GFT505 120mg (GFT505 120mg)	qbzjgduznq(idbnmbmeij) = rvwvolbcma lhmiupscta (xkmfwosapg, 1.68) View more

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