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Genfit SA (GNFT.PA)
| Clôture précédente | 4,0060 |
| Ouverture | 3,9900 |
| Offre | 0,0000 x 0 |
| Vente | 0,0000 x 0 |
| Var. jour | 3,8560 - 4,0000 |
| Sur 52 semaines | 3,8540 - 20,9600 |
| Volume | 1 112 652 |
| Volume moyen | 347 240 |
| Cap. boursière | 153,63M |
| Bêta (mensuel sur 5 ans) | 0,92 |
| Rapport P/E (sur 12 mois) | S.O. |
| BPA (sur 12 mois) | -1,7610 |
| Date de bénéfices | 08 avr. 2020 |
| Dividende et rendement à terme | S.O. (S.O.) |
| Date ex-dividende | S.O. |
| Objectif sur 1 an | 63,89 |
- Globe Newswire
GENFIT Announces Two Oral Presentations at the Digital International Liver Congress™ 2020
Lille, France; Cambridge, M.A.; August 26, 2020 \- GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and liver diseases, announced two oral presentations on new non-alcoholic steatohepatitis (NASH) data, at the Digital International Liver Congress™ 2020, the 55th Annual Meeting of the European Association for the Study of the Liver (EASL), to be held virtually August 27-29, 2020. The first presentation will highlight and support the role of biomarker, miR-34a - a key component of NIS4™ technology - in ruling out NAFLD and its role in the identification of patients with at-risk NASH. The second presentation will discuss the positive, pre-clinical data of GENFIT’s lead compound, elafibranor, in combination with semaglutide, in reducing liver inflammation. The full scientific program for The Digital International Liver Congress™ 2020 is available through the Digital International Liver Congress website. Oral Presentations:Title: Serum levels of miR-34a to rule-out NAFLD in healthy subjects and identify NAFLD patients with active NASH (NAS≥4) and significant liver fibrosis (F≥2)Presentation Number: AS102Presenter: Arun J. SanyalAuthors: Stephen A. Harrison et al.Session: August 27, 2020 – 12:15-12:30 CET – Channel 3Title: The combination of elafibranor and semaglutide drastically improves fibrosing steatohepatitis and distinctly modulates liver inflammatory signature Presentation Number: AS014Presenter: Robert Walczak Authors: Vanessa Legry et al.Session: August 28, 2020 – 15:45-16:00 CET – Channel 3ABOUT NIS4™NIS4™ is GENFIT’s non-invasive, blood-based diagnostic technology, which was developed to identify patients with non-alcoholic steatohepatitis (NASH) and significant to advanced fibrosis (F>2), also referred to as at-risk NASH. In January 2019, GENFIT signed a licensing agreement with LabCorp® to make NIS4™ technology available for use in clinical research through their drug development subsidiary, Covance. GENFIT also continues to explore opportunities to obtain formal marketing authorization of an in vitro diagnostic (IVD) version of NIS4™ in both the U.S. and European markets. For more information, please visit: https://nis4.com.ABOUT NASHNASH is a liver disease characterized by an accumulation of fat (lipid droplets), along with inflammation and degeneration of hepatocytes. The disease is associated with an increased risk of cardiovascular disease along with long-term risk for progression to cirrhosis, leading to liver insufficiency and potential progression to liver cancer. NASH is a serious disease that often carries no symptoms in its early stages, but if left untreated can result in cirrhosis, cancer, and the need for liver transplant. The prevalence of NASH is rapidly increasing as a result of the growing obesity and diabetes epidemics and is believed to affect as much as 12 percent of people in the U.S. and six percent worldwide. ABOUT GENFITGENFIT is a late-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and liver diseases. GENFIT is a pioneer in the field of nuclear receptor-based drug discovery, with a rich history and strong scientific heritage spanning more than two decades. GENFIT plans to initiate a Phase 3 clinical trial of elafibranor in patients with PBC. As part of GENFIT’s comprehensive approach to clinical management of patients with liver disease, the Company is also developing NIS4™, a new, non-invasive blood-based diagnostic technology which, if approved, could enable easier identification of patients with at-risk NASH. With facilities in Lille and Paris, France, and Cambridge, MA, USA, the Company has approximately 200 employees. GENFIT is a publicly traded company listed on the Nasdaq Global Select Market and on compartment B of Euronext’s regulated market in Paris (Nasdaq and Euronext: GNFT). www.genfit.com FORWARD LOOKING STATEMENTSThis press release contains certain forward-looking statements, including those within the meaning of the Private Securities Litigation Reform Act of 1995, with respect to GENFIT, including statements about the performance of NIS4™ in the identification of NAFLD patients at risk of NASH and the potential benefits of a combination of elafibranor and semaglutide in the reduction of hepatic inflammation. The use of certain words, including “believe,” “potential,” “expect” and “will” 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 other things, the uncertainties inherent in research and development, including related to safety, biomarkers, progression of, and results from, its ongoing and planned clinical trials, review and approvals by regulatory authorities of its drug and diagnostic candidates and the Company’s continued ability to raise capital to fund its development, as well as those risks and uncertainties discussed or identified in the Company’s public filings with the French Autorité des marchés financiers (“AMF”), including those listed in Section 2.1 “Main Risks and Uncertainties” of the Company’s 2019 Universal Registration Document filed with the AMF on May 27, 2020 under n° D.20-0503, which is available on GENFIT’s website (www.genfit.com) and on the website of the AMF (www.amf-france.org) and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s 20-F dated May 27, 2020. In addition, even if the Company’s results, performance, financial condition and liquidity, 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 document. 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. GENFIT CONTACTGENFIT | InvestorsNaomi EICHENBAUM – Investor Relations | Tel: +1 (617) 714 5252 | investors@genfit.comPRESS RELATIONS | MediaHélène LAVIN – Press Relations | Tel: +3 33 2016 4000 | helene.lavin@genfit.com GENFIT | 885 Avenue Eugène Avinée, 59120 Loos - FRANCE | +333 2016 4000 | www.genfit.com Attachment * GENFIT Announces Two Oral Presentations at the Digital International Liver Congress™ 2020
- Globe Newswire
GENFIT annonce deux présentations orales au Congrès Digital International Liver Congress™ 2020
Lille, France; Cambridge (Massachussetts, Etats-Unis); le 26 août 2020 - GENFIT (Nasdaq et Euronext: GNFT), société biopharmaceutique de phase avancée engagée dans l’amélioration de la vie des patients atteints de maladies hépatiques et métaboliques, annonce deux présentations orales sur de nouvelles données dans la NASH au Digital International Liver Congress™ 2020, le 55ème Congrès Annuel de l’European Association for the Study of the Liver (EASL), qui se tiendra du 27 au 29 août 2020. Une première présentation soulignera le rôle du biomarqueur miR-34a - un des composants essentiels de la technologie NIS4™ - pour exclure le diagnostic de la NAFLD et faciliter l’identification des patients NAFLD présentant des facteurs de risque de NASH.Une seconde présentation détaillera les résultats positifs précliniques obtenus par elafibranor - le composé le plus avancé de la Société – en combinaison avec semaglutide dans la réduction de l’inflammation hépatique. Le programme scientifique complet est disponible sur le site du Digital International Liver Congress™ 2020.Présentations Orales :Titre : Serum levels of miR-34a to rule-out NAFLD in healthy subjects and identify NAFLD patients with active NASH (NAS≥4) and significant liver fibrosis (F≥2)Numéro : AS102Présenté par : Arun SanyalAuteurs : Stephen A. Harrison et. alSession : Jeudi 27 août 2020 – 12:15-12:30 CET – Channel 3Titre : The combination of elafibranor and semaglutide drastically improves fibrosing steatohepatitis and distinctly modulates liver inflammatory signatureNuméro : AS014Présenté par : Robert Walczak Auteurs : Vanessa Legry et. alSession : Vendredi 28 août – 15:45-16:00 CET – Channel 3A PROPOS DE NIS4™ NIS4™ est la technologie non-invasive de GENFIT, basée sur une prise de sang et développée afin d’identifier les patients atteints de stéatohépatite non-alcoolique (NASH) avec fibrose significative (F>2) également définie comme NASH à risque. En janvier 2019, GENFIT a signé un accord de licence avec LabCorp® afin de déployer le kit diagnostic NIS4™ dans le domaine de la recherche clinique au travers de leur filiale de développement de médicaments, Covance. GENFIT continue d’explorer les opportunités d’obtention d’une autorisation formelle de mise sur le marché d’une version in vitro diagnostic (IVD) de NIS4™ à la fois sur les marchés aux Etats-Unis et en Europe. Pour plus d’informations : https://nis4.com. À PROPOS DE LA NASHLa « NASH » est une maladie du foie qui associe une accumulation de graisse dans le foie (gouttelettes de lipides), une inflammation et une dégénérescence des cellules hépatiques. La maladie est associée à un risque cardiovasculaire accru ainsi qu’un risque à long terme de progression vers la cirrhose, conduisant à une insuffisance hépatique et potentiellement au cancer du foie. La NASH est une maladie grave qui ne présente souvent aucuns symptômes à ses débuts, mais qui peut évoluer vers la cirrhose, le cancer, ou la transplantation si elle n’est pas traitée. La prévalence de la NASH augmente rapidement en raison de la double épidémie de diabète et d’obésité, et l’on estime qu’elle affecte jusqu’à 12% de la population aux Etats Unis et 6% dans le monde.A PROPOS DE GENFIT GENFIT est une société biopharmaceutique de phase avancée engagée dans l’amélioration de la vie des patients atteints de maladies hépatiques et métaboliques. GENFIT est pionnier dans le domaine de la découverte de médicaments basés sur les récepteurs nucléaires, fort d'une histoire riche et d'un solide héritage scientifique de près de deux décennies. GENFIT prévoit d’initier un essai clinique de Phase 3 évaluant elafibranor dans la PBC. Abordant la prise en charge clinique des patients atteints de maladies hépatiques à travers une approche intégrée, GENFIT développe également NIS4™, une technologie nouvelle de diagnostic sanguin, qui, si elle est approuvée, permettrait l’identification des patients atteints de NASH à risque. Installée à Lille, Paris et Cambridge, MA (USA), l’entreprise compte environ 200 collaborateurs. GENFIT est une société cotée sur le Nasdaq Global Select Market et sur le marché réglementé d’Euronext à Paris, Compartiment B (Nasdaq et Euronext: GNFT). www.genfit.fr AVERTISSEMENT Ce communiqué de presse contient des déclarations prospectives à propos de GENFIT, y compris au sens où l’entend le Private Securities Litigation Reform Act de 1995 et en particulier des déclarations prospectives relatives à la performance de NIS4™ dans l’identification de patients atteints de NAFLD à risque de NASH et au bénéfice potentiel d’une combinaison d’elafibranor et de semaglutide dans la réduction de l’inflammation hépatique. L’utilisation de certains mots, comme « penser », « potentiel », « espérer », « devrait » et d’autres tournures ou expressions similaires, a pour but d’identifier ces déclarations prospectives. Bien que la Société considère que ses projections soient basées sur des hypothèses et attentes raisonnables de sa Direction Générale, ces déclarations prospectives peuvent être remises en cause par un certain nombre d’aléas et d’incertitudes connus ou inconnus, ce qui pourrait donner lieu à des résultats substantiellement différents de ceux décrits, induits ou anticipés dans lesdites déclarations prospectives. Ces aléas et incertitudes comprennent, parmi d’autres, les incertitudes inhérentes à la recherche et développement, y compris dans le domaine des biomarqueurs, au progrès et aux résultats des essais cliniques prévus et en cours, aux examens et autorisations d’autorités réglementaires concernant ses candidats-médicaments et solutions diagnostiques, à la capacité de la Société à continuer à lever des fonds pour son développement, ainsi qu’à ceux développés à la section 4 «Principaux Risques et incertitudes» du Document de Référence 2019 de la Société enregistré par l’Autorité des marchés financiers (AMF) le 27 mai 2020 sous le numéro D.20-0503, qui est disponible sur les sites Internet de GENFIT (www.genfit.fr) et de l’AMF (www.amf-france.org) et à ceux développés dans les documents publics et rapports déposés auprès de la Securities and Exchange Commissions américaine (« SEC »), dont le prospectus final de la Société daté du 26 mars 2019, et dans les documents publics et rapports consécutifs déposés auprès de l’AMF et de la SEC, ou rendus publics par ailleurs par la Société. De plus, même si les résultats, la performance, la situation financière et la liquidité de la Société et le développement du secteur industriel dans lequel elle évolue sont en ligne avec de telles déclarations prospectives, elles ne sauraient être prédictives de résultats ou de développements dans le futur. Ces déclarations prospectives ne sont valables qu’à la date de publication de ce document. Sous réserve de la réglementation applicable, la Société ne prend aucun engagement de mise à jour ou de révision des informations contenues dans ce communiqué, que ce soit en raison de nouvelles informations, d’évènements futurs ou autres.CONTACTGENFIT | InvestisseursNaomi EICHENBAUM – Relations Investisseurs | Tel : +1 (617) 714 5252 | investors@genfit.comRELATIONS PRESSE | MediaBruno ARABIAN – Ulysse Communication | Tel : 06 87 88 47 26 | barabian@ulysse-communication.com Hélène LAVIN – GENFIT | Tel : 03 20 16 40 00 | helene.lavin@genfit.comGENFIT | 885 Avenue Eugène Avinée, 59120 Loos - FRANCE | +333 2016 4000 | www.genfit.com Pièce jointe * GENFIT annonce deux presentations orales au Congres Digital International Liver Congress™ 2020
- Globe Newswire
GENFIT Announces Pivotal Publication of NIS4™ Technology to Identify Patients with At-Risk NASH in The Lancet Gastroenterology & Hepatology
Lille (France), Cambridge (Massachusetts, United States), August 05, 2020 – GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and chronic liver diseases, today announced that pivotal data describing the derivation and validation of NIS4™ has been accepted for publication by The Lancet Gastroenterology & Hepatology. NIS4™ is GENFIT’s novel non-invasive, blood-based diagnostic technology, developed to identify patients with non-alcoholic steatohepatitis (NASH) and significant to advanced fibrosis (F>2), also referred to as at-risk NASH in the published study. Suneil Hosmane, PhD, Head of Global Diagnostics at GENFIT commented: “This publication represents a milestone achievement for our NIS4™ technology. The data presented in The Lancet Gastroenterology and Hepatology showcases not only the robust and consistent performance of NIS4™ to identify at-risk NASH, but also the improved performance of NIS4™ relative to other technologies including commonly used liver fibrosis tests. We believe blood-based diagnostic tests powered by NIS4™ technology will play a critical role in the diagnosis and management of patients with NASH. The majority of patients with at-risk NASH, who are at higher risk of progression to severe liver complications, have not been diagnosed and a non-invasive approach to identify them is paramount. The complexity of underlying chronic liver diseases, such as NASH, is that these conditions often do not present with obvious symptoms until the disease is in very advanced stages. Hence, we believe non-invasive testing will continue to gain importance within healthcare systems given the capability to identify those who may require more aggressive medical intervention with a simple blood draw while maintaining high diagnostic accuracy.”The NIS4™ technology is an algorithm that incorporates four independent NASH-associated biomarkers – miR-34a-5p, A2M, YKL-40, and HbA1c – to produce a score that can be utilized to identify patients with or without at-risk NASH. This published study details NIS4™ algorithm development and clinical validation against the liver biopsy reference standard in two independent populations comprised of data from over 700 patients. Apart from high overall diagnostic performance, NIS4™ also provided consistent results in critical sub-populations (i.e. diabetic vs. non-diabetic, men vs. women) as compared to other non-invasive tests evaluated in the same individuals. Prof. Arun Sanyal, MD, Department of Internal Medicine, Virginia Commonwealth University School of Medicine in Richmond, VA, USA, noted: “There is a major unmet need to establish simple tools that can be used in all patients with risk factors to identify those with non-alcoholic steatohepatitis with enough disease activity and fibrosis to be considered for more intense therapies over and above lifestyle changes. The current study is a key step in meeting this unmet need and demonstrates that the NIS4 score can be used to enrich the likelihood of identifying this subpopulation amongst those who are overweight or are obese with or without diabetes. This paves the way for development of patient identification and treatment paradigms that are non-invasive and available to all clinics.”GENFIT intends to license NIS4™ technology to a major diagnostic partner to enable the development and projected launch of a clinical diagnostic test powered by NIS4™ in the second half of 2020. GENFIT also continues to explore opportunities to obtain formal marketing authorization of an in vitro diagnostic (IVD) version of NIS4™ in both the U.S. and European markets.ABOUT NIS4™NIS4™ is GENFIT’s non-invasive, blood-based diagnostic technology, which was developed to identify patients with non-alcoholic steatohepatitis (NASH) and significant to advanced fibrosis (F>2), also referred to as at-risk NASH. In January 2019, GENFIT signed a licensing agreement with LabCorp® to make NIS4™ technology available for use in clinical research through their drug development subsidiary, Covance. GENFIT also continues to explore opportunities to obtain formal marketing authorization of an in vitro diagnostic (IVD) version of NIS4™ in both the U.S. and European markets. For more information, please visit: https://nis4.com ABOUT GENFITGENFIT is a late-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and liver diseases. GENFIT is a pioneer in the field of nuclear receptor-based drug discovery, with a rich history and strong scientific heritage spanning more than two decades. GENFIT plans to initiate a Phase 3 clinical trial of elafibranor in patients with PBC. As part of GENFIT’s comprehensive approach to clinical management of patients with liver disease, the Company is also developing NIS4™, a new, non-invasive blood-based diagnostic technology which, if approved, could enable easier identification of patients with at-risk NASH. With facilities in Lille and Paris, France, and Cambridge, MA, USA, the Company has approximately 200 employees. GENFIT is a publicly traded company listed on the Nasdaq Global Select Market and on compartment B of Euronext’s regulated market in Paris (Nasdaq and Euronext: GNFT). www.genfit.com FORWARD LOOKING STATEMENTSThis press release contains certain forward-looking statements, including those within the meaning of the Private Securities Litigation Reform Act of 1995, with respect to GENFIT, including statements about NIS4™’s performance in identifying patients with at-risk NASH, the performance of NIS4™ relative to other technologies, the potential for diagnostic tests powered by NIS4™ technology to play a critical role in the diagnosis and management of patients with NASH, the potential for non-invasive testing to gain importance, its capability to identify patients who may require medical intervention, the development plans for NIS4™ in the U.S. and in Europe and timing of such development plans, the ability of GENFIT to license the NIS4™ technology to a major diagnostic partner and the timing thereof and the potential to obtain formal marketing authorization of an IVD version of NIS4™ in the U.S. and/or European markets. The use of certain words, including “believe,” “potential,” “expect” and “will” 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 other things, the uncertainties inherent in research and development, including related to safety, biomarkers, progression of, and results from, its ongoing and planned clinical trials, review and approvals by regulatory authorities of its drug and diagnostic candidates and the Company’s continued ability to raise capital to fund its development, as well as those risks and uncertainties discussed or identified in the Company’s public filings with the French Autorité des marchés financiers (“AMF”), including those listed in Section 2.1 “Main Risks and Uncertainties” of the Company’s 2019 Universal Registration Document filed with the AMF on May 27, 2020 under n° D.20-0503, which is available on GENFIT’s website (www.genfit.com) and on the website of the AMF (www.amf-france.org) and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s 20-F dated May 27, 2020. In addition, even if the Company’s results, performance, financial condition and liquidity, 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 document. 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. CONTACTGENFIT | InvestorsNaomi EICHENBAUM – Investor Relations | Tel: +1 (617) 714 5252 | investors@genfit.com PRESS RELATIONS | MediaHélène LAVIN – Press relations | Tel: +333 2016 4000 | helene.lavin@genfit.com GENFIT | 885 Avenue Eugène Avinée, 59120 Loos - FRANCE | +333 2016 4000 | www.genfit.com Attachment * GENFIT Announces Pivotal Publication of NIS4™ Technology to Identify Patients with At-Risk NASH in The Lancet Gastroenterology & Hepatology
