Elafibranor

IQIRVO ® data expands scientific evidence in fatigue, showing clinically meaningful improvements in patients with moderate-to-severe fatigue at baseline In the first real-world analysis in patients with PBC and an ALP 1-1.67 x ULN, IQIRVO demonstrated a significant ALP reduction, with 59% of patients achieving ALP normalization at 6 months Interim analysis from the ELFINITY Phase IV study highlights real-world effectiveness and tolerability of IQIRVO in both biochemical and symptom control, including fatigue and pruritus PARIS, FRANCE, 28 MAY 2026 - Ipsen (Euronext: IPN; ADR: IPSEY) today announced the presentation of new late-breaking results from the ELATIVE ® Phase III trial and two real-world studies at the European Association for the Study of the Liver (EASL) congress. Together, these data further strengthen the growing body of evidence establishing IQIRVO ® as the only second-line primary biliary cholangitis (PBC) treatment providing rapid and robust alkaline phosphatase (ALP) reduction with fatigue improvement (in patients with moderate-to-severe fatigue at baseline) and pruritus relief. In a post hoc analysis of the pivotal ELATIVE study, shared in a late-breaking presentation, patients with moderate-to-severe fatigue at baseline experienced greater fatigue reductions with IQIRVO compared to placebo across 52 weeks. A clinically meaningful improvement in fatigue was achieved in 67% of patients on IQIRVO vs 31% on placebo (p=0.020) at Week 52, with improvements observed as early as Week 4. The benefits of IQIRVO vs placebo were observed across multiple dimensions of physical and mental fatigue, including extreme exhaustion (62% vs 31%), too tired to think clearly (57% vs 31%) and too tired to bath or shower (55% vs 25%), highlighting the breadth of improvement across several symptom domains. “Fatigue is one of the most debilitating symptoms of PBC and has long represented a significant unmet need for patients and clinicians,” said David Jones, Professor of Liver Immunology for the Faculty of Medical Science at Newcastle University. “These data are particularly encouraging, showing that IQIRVO led to clinically meaningful improvements in fatigue compared with placebo. Importantly, improvements were seen across multiple dimensions of fatigue, including outcomes that matter most to patients.” In a second late-breaking presentation, a U.S. real-world analysis using the Health Verity database, evaluated outcomes in patients with ALP elevated between 1-1.67 times the upper limit of normal (ULN). These data showed that improvements were observed through to month 6 in patients who were naïve to second-line treatment with 72% of patients having a ≥15% ALP reduction, a decline in mean ALP from 174 U/L to 131 U/L and 59% of patients achieving ALP normalization. Normalization of ALP is recognized as a key treatment goal for improved long-term prognosis and slowing disease progression in PBC. These data are the first real-world evidence establishing the benefit of IQIRVO on ALP normalization within this patient population. In a third late-breaker, interim month 3 findings from the global Phase IV ELFINITY ® study, conducted in routine clinical practice, showed IQIRVO delivered rapid and sustained reductions in ALP for three months, with biochemical response achieved in 55% of patients. More than half of patients with baseline moderate-to-severe fatigue experienced clinically meaningful improvements by month 3 as well as clinically important improvements in pruritus. IQIRVO demonstrated a favorable tolerability pro with previous studies, with no serious or severe treatment-emergent adverse events reported. “The growing evidence from both controlled trials and real-world practice highlights the meaningful difference IQIRVO can make for people living with PBC,” said Sandra Silvestri, MD, PhD, Chief Medical Officer, Ipsen. “Across multiple studies, we see consistent improvements in both biochemical control, a key marker of disease progression, and in the debilitating symptoms of fatigue and pruritus, which are independent of each other. These data further reinforce IQIRVO’s potential to address both disease biology and symptom burden in a meaningful and clinically relevant way.” About IQIRVO ® (elafibranor) IQIRVO is an oral, once-daily, peroxisome proliferator-activated receptor (PPAR) agonist. Activation of PPARα and PPARδ decreases bile toxicity and improves cholestasis by modulating bile acid synthesis, detoxification and transporters. IQIRVO is the first approved PPAR agonist with dual α and δ activation, shown to have complementary anti-inflammatory, anti-cholestatic, anti-fibrotic and metabolic effects. In 2019, IQIRVO was granted Breakthrough Therapy Designation by the U.S Food and Drug Administration (FDA) in adults with PBC who have an inadequate response to ursodeoxycholic acid (UDCA), the existing first-line therapy for PBC. IQIRVO was granted U.S. FDA accelerated approval in June 2024, conditional approval by the EMA in September 2024 and UK Medicines and Healthcare products Regulatory Agency (MHRA) in October 2024, for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. The FDA and EMA approvals are contingent on the further verification of clinical benefit. In addition to the U.S., E.U. and UK, IQIRVO is approved in Canada, Australia, Brazil and 13 other countries and is in regulatory processes with other authorities. IQIRVO was developed by GENFIT. Ipsen licensed the exclusive worldwide rights (except China, Hong Kong, Taiwan and Macau) to elafibranor from GENFIT in 2021 and expanded the geographical scope to China, Hong Kong, Taiwan and Macau in March 2026. About Primary Biliary Cholangitis PBC is a rare, autoimmune liver disease where a build-up of bile and toxins and chronic inflammation cause irreversible fibrosis of the liver and destruction of the bile ducts. Impacting approximately 100,000 people in the US 1 and 115,000 people in Europe 2 , the majority being women, PBC is a lifelong condition that can worsen over time if not effectively treated and may lead to liver transplant and in some cases, premature death. About Ipsen We are a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Our pipeline is fueled by internal and external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K. Our teams in more than 40 countries and our partnerships around the world enable us to bring medicines to patients in more than 100 countries. Ipsen is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com . Ipsen Contacts Investors Henry Wheeler henry.wheeler@ipsen.com +33 7 66 47 11 49 Khalid Deojee khalid.deojee@ipsen.com +33 6 66 01 95 26 Media Sally Bain sally.bain@ipsen.com +1 857 320 0517 Anne Liontas anne.liontas.ext@ipsen.com +33 7 67 34 72 96 Disclaimers and/or forward-looking statements The forward-looking statements, objectives and targets contained herein are based on Ipsen’s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect Ipsen’s future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. Use of the words ‘believes’, ‘anticipates’ and ‘expects’ and similar expressions are intended to identify forward-looking statements, including Ipsen’s expectations regarding future events, including regulatory filings and determinations. Moreover, the targets described in this document were prepared without taking into account external-growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by Ipsen. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising medicine in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons. Ipsen must face or might face competition from generic medicine that might translate into a loss of market share. Furthermore, the research and development process involves several stages each of which involves the substantial risk that Ipsen may fail to achieve its objectives and be forced to abandon its efforts with regards to a medicine in which it has invested significant sums. Therefore, Ipsen cannot be certain that favorable results obtained during preclinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the medicine concerned. There can be no guarantees a medicine will receive the necessary regulatory approvals or that the medicine will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Other risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and healthcare legislation and risks arising from unexpected regulatory or political changes such as changes in tax regulation and regulations on trade and tariffs, such as protectionist measures, especially in the United States; global trends toward healthcare cost containment; technological advances, new medicine and patents attained by competitors; challenges inherent in new-medicine development, including obtaining regulatory approval; Ipsen’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Ipsen’s patents and other protections for innovative medicines; and the exposure to litigation, including patent litigation, and/or regulatory actions. Ipsen also depends on third parties to develop and market some of its medicines which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to Ipsen’s activities and financial results. Ipsen cannot be certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of Ipsen’s partners could generate lower revenues than expected. Such situations could have a negative impact on Ipsen’s business, financial position or performance. Ipsen expressly disclaims any obligation or undertaking to update or revise any forward-looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. Ipsen’s business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers. The risks and uncertainties set out are not exhaustive and the reader is advised to refer to Ipsen’s latest Universal Registration Document, available on ipsen.com References LU M, Zhou, et al. Fibrotic Liver Disease Consortium Investigators. Increasing Prevalence of Primary Biliary Cholangitis and Reduced Mortality With Treatment. Clin Gastroenterol Hepatol. 2018 Aug;16(8):1342-1350.e1. DOI: 10.1016/j.cgh.2017.12.033. Gazda J, et. al. The Epidemiology of Primary Biliary Cholangitis in European Countries: A Systematic Review and Meta-Analysis. Can J Gastroenterol Hepatol. 2021 Jun 19;2021:9151525. doi: 10.1155/2021/9151525. Attachment Ipsen PR_EASL_28052026

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), May 25, 2026 – GENFIT (Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today highlights its broad participation at EASL Congress 2026. This visibility reflects both its scientific momentum and its active involvement in the ACLF ecosystem, as well as its position at an inflection point in MASH, while also highlighting the continuous progress made in PBC, driven by its partner Ipsen. I. GENFIT Posters Seven posters have been accepted for presentation at EASL Congress mainly covering GENFIT’s key assets positioned in Acute on-Chronic Liver Failure (ACLF) and including GENFIT’s latest work on Real-World data in ACLF. ACLF – Scientific Data Poster FRI-384: G1090N - Differential activity of nitazoxanide vs rifaximin in lipopolysaccharide-induced disease models Poster FRI-383: G1090N - Effect of nitazoxanide on organ failures in disease models of alcohol-mediated ACLF Poster FRI-412: SRT-015 - Balancing immune dysfunction in ACLF: ASK1 inhibitor SRT-015 mitigates inflammatory responses while enhancing immune antibacterial defenses ACLF – Real-World Data Poster TOP-032: Real-world data highlight gaps in hospital care and access to gastroenterologists or hepatologists in patients with acutely decompensated cirrhosis Poster SAT-468: Clinical impact of bacterial infections in acutely decompensated cirrhosis: insights from 4.97 million admissions Poster SAT-478: Use and effectiveness of lactulose and rifaximin in patients with cirrhosis and hepatic encephalopathy Poster WED-499: Closing the coding gap: International Classification of Diseases (ICD)-10 code K76.82 for hepatic encephalopathy achieves rapid uptake in U.S. real world practice GENFIT did not submit data on GNS561 in cholangiocarcinoma at this stage, as dose escalation in the ongoing Phase 1 study is continuing. Given its oncology focus, this program is expected to be featured at international congresses such as ASCO1 and ESMO2. II. ACLF elevated to a strategic priority across the ecosystem As a result of GENFIT’s efforts, engagement around ACLF has strengthened, advancing understanding of key clinical and regulatory challenges and positioning ACLF as a shared strategic priority among leading stakeholders, including the Forum for Collaborative Research. This momentum is set to materialize at the following two key events at the 2026 congress. May 26, 2026: Global Consensus Meeting on Harmonizing the Definition of ACLF For the first time, EASL and its sister societies AASLD3, APASL4, ALEH5, and SOLDA6 will come together to forge a unified global definition of ACLF. This initiative aims to overcome long-standing regional differences and accelerate progress for patients worldwide. The first outcomes of this collaboration will be presented during this multistakeholder event, taking place at the Porta Fira Hotel in Barcelona, the day before the official start of EASL Congress 2026. May 27, 2026: ACLF Insights event GENFIT and EF CLIF will co‑host their annual ACLF Insights event, beginning with an update from Dr. Veronica Miller, PhD, Adjunct Professor at Berkeley Public Health and Director of the Forum for Collaborative Research (USA), and Dr. Richard Moreau, MD, Senior Scientist at INSERM and Director of the European Foundation for the Study of Chronic Liver Failure (EF CLIF). They will introduce the governance framework of the ACLF Program announced at the end of last year by the Forum for Collaborative Research and recently launched. Dr. Jonel Trebicka, MD, PhD, Head of Department and Professor of Medicine at the University of Münster (Germany), will then discuss translational science and highlight key approaches used in the field. GENFIT will close the session with an update on its programs. III. Rising importance of GENFIT’s MASH non-invasive diagnostic MASH will be a prominent area of interest at the EASL Congress, with around 250 abstracts including 4 late breakers presented in the 2026 edition, including contributions from large pharmaceutical and biotechnology companies. This momentum reflects a rapidly expanding therapeutic market, highlighted by the near-blockbuster performance of first approved treatments in their initial year, further increasing the need for scalable patient identification. While GENFIT will not be presenting data this year, its NIS2+® non-invasive diagnostic technology is already embedded in EASL–EASD–EASO guidelines. As therapies expand, addressing persistent underdiagnosis and enabling patient identification at scale becomes critical, reinforcing the strategic positioning of GENFIT’s technology. IV. New data presented by Ipsen on Iqirvo® in Primary Biliary Cholangitis (PBC) Ipsen will be presenting six new datasets during the EASL Congress, including late-breaking abstracts bringing new insights into disease management, combining real-world evidence and patient-reported outcomes to better understand both disease progression and patient experience: Poster LBP-033: Elafibranor treatment results in rapid reductions in biochemical markers and symptom burden: data from the ongoing prospective, non-interventional ELFINITY phase IV global study in patients with primary biliary cholangitis Poster LBP-018: Improvements in fatigue in patients with primary biliary cholangitis treated with elafibranor: Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a (PFSF 7a) data from the phase III ELATIVE® trial Poster LBP-023: Real-world outcomes in patients with primary biliary cholangitis who initiated elafibranor treatment with baseline alkaline phosphatase less than 1.67× the upper limit of normal Poster SAT-396: Bone mineral density is stable in patients with primary biliary cholangitis receiving up to 3.5 years of elafibranor treatment Poster SAT-364: Long-term improvements in lipid profiles with elafibranor treatment, and favourable safety with concomitant statin use, in patients with primary biliary cholangitis during the open-label extension of the phase III ELATIVE® trial Poster SAT-300: Long-term treatment with elafibranor improves markers of immune response and inflammation in primary biliary cholangitis 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.7 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 regarding the Company’s participation in EASL Congress 2026, the expected scientific and strategic momentum in Acute-on-Chronic Liver Failure (ACLF), the growing importance of MASH and related diagnostic technologies, the advancement of GENFIT’s research and development programs, including in ACLF and other indications, the ongoing development of GNS561, and the potential progress and impact of elafibranor in Primary Biliary Cholangitis (PBC) by Ipsen. 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 2025 Universal Registration Document filed on April 3, 2026 (no. 26-0221) 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 reports filed with the AMF 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 | www.genfit.com 1 American Society of Clinical Oncology (ASCO)2 European Society for Medical Oncology (ESMO)3 The American Association for the Study of Liver Diseases, a professional organization dedicated to advancing the science and practice of hepatology4 Asia-Pacific Association for the Study of the Liver, a regional organization supporting research and education in hepatology.5 Latin American Association for the Study of the Liver, a scientific association promoting liver research and education in Latin America.6 Society on Liver Disease in Africa, an organization promoting liver health research and education across Africa7 Elafibranor is marketed and commercialized, notably in the U.S and Europe, by Ipsen under the trademark Iqirvo® Attachment GENFIT Highlights Broad Scientific and Strategic Presence at EASL Congress 2026