Articles from GENFIT S.A.

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), April 29, 2025 - GENFIT (Nasdaq and Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announces the filing of its 2024 Universal Registration Document with the Autorité des marches financiers (AMF ; filing n° D.25-0331) and its Annual Report on Form 20-F for the year ended December 31, 2024 with the U.S. Securities and Exchange Commission (SEC). 

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), April 28, 2025 - GENFIT (Nasdaq and Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced that Ipsen will be presenting data from its late-breaking abstract on elafibranor, highlighting favorable safety profile and significant efficacy in Primary Sclerosing Cholangitis (PSC), at the European Association for the Study of the Liver (EASL) on May 10, 2025 at 11.15 CET.

Lille, France; Cambridge, MA; Zurich, Switzerland; April 24, 2025 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced annual financial results for the year ended December 31, 2024. A summary of the consolidated financial statements is included below.

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), March 20, 2025 - GENFIT (Nasdaq and Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases (the “Company”), is pleased to announce the successful completion of its royalty financing transaction with HealthCare Royalty (“HCRx”) and the results of the repurchase offer to 2025 OCEANEs holders.

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), March 10, 2025 - GENFIT (Nasdaq and Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases (the “Company”), today announces the results of the bondholders’ vote at the general meeting of the 2025 OCEANEs holders which took place this Monday, March 10, 2025 at 2:30pm (Paris time): all resolutions proposed by the Company were approved.

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), February 27, 2025 - GENFIT (Nasdaq and Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced its cash position as of December 31, 2024 and revenues for 2024

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), February 21, 2025 - GENFIT (Nasdaq and Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announces that it has signed Put Option Agreements with 2025 OCEANEs holders and the convening of the general meeting of the 2025 OCEANEs holders for March 10, 2025.

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), February 14, 2025 - GENFIT (Nasdaq and Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced the amendment of the final terms of the 2025 OCEANEs repurchase proposal and the consent fee that would be paid to the holders of 2025 OCEANEs still outstanding after cancellation of repurchased 2025 OCEANEs.

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), February 10, 2025 - GENFIT (Nasdaq and Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced the final terms of the 2025 OCEANEs repurchase proposal and the consent fee that would be paid to the holders of 2025 OCEANEs still outstanding after cancellation of repurchased 2025 OCEANEs.

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), February 6, 2025 - GENFIT (Nasdaq and Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today outlines the design of new clinical trials within its Acute on-Chronic Liver Failure (ACLF) pipeline, with several clinical data readouts by end of 2025.

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), January 30, 2025 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases (the “Company”), today announces that it has entered into a non-dilutive capped royalty financing agreement with HealthCare Royalty (HCRx) for up to €185 million, and debt overhang resolution plan.

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), January 29, 2025 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced its provisional financial calendar for 2025.

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), November 13, 2024 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today provided a corporate update ahead of The Liver Meeting 2024®2.

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland); November 7, 2024 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced its cash position as of September 30, 2024 and revenue for the first nine months of 20241.

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), September 23, 2024 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced that the European Commission has conditionally approved Iqirvo®1 (elafibranor) 80mg tablets for the treatment of Primary Biliary Cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as a monotherapy in patients unable to tolerate UDCA. This follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on July 26, 2024 and the U.S. FDA Accelerated Approval on June, 10, 2024 .

Lille (France), Cambridge (Massachusetts, United States), (Zurich, Switzerland); September 19, 2024 – GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced its first half-year 2024 financial results and provided a corporate update.

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), July 26, 2024 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency's (EMA) for Ipsen’s Iqirvo® (elafibranor) for the treatment of Primary Biliary Cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as a monotherapy in patients unable to tolerate UDCA.

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), June 17, 2024 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced the inclusion of NIS2+® as a key tool for detecting at-risk MASH1 in the European Clinical Practice Guidelines on the management of metabolic dysfunction-associated steatotic liver disease (MASLD).

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), June 10, 2024 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced the achievement of a historic corporate milestone: the U.S. Food and Drug Administration (FDA) accelerated approval of Iqirvo1 (elafibranor)2 80 mg tablets – as unveiled today by Ipsen (Euronext: IPN; ADR: IPSEY) – as a first-in-class treatment for PBC in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), May 29, 2024 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today detailed its presence at the EASL Congress™ 2024.

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), May 22, 2024 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced the results of the Combined Shareholders Meeting which took place on May 22, 2024. The quorum on first convening amounted to 27.25% and shareholders approved all of the resolutions.

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), May 14, 2024 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced its cash position as of March 31, 2024 and revenues for the first three months of 2024.1

Lille (France), Cambridge (Massachusetts, USA), Zurich (Switzerland), April 25, 2024 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company committed to improving the lives of patients with rare, life-threatening liver diseases, today announced the publication of its 2024 Extra-Financial Performance Report (fiscal year 2023).

Lille (France); Cambridge (Massachusetts, United States); Zurich (Switzerland); April 15, 2024 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced that it published in the April 15, 2024 French legal announcements bulletin n°46 (Bulletin des Annonces Légales Obligatoires) its convening notice that the Combined Shareholders Meeting will be held on May 22, 2024, at 10:00am (CET), at the Faculty of Pharmaceutical Sciences in Lille, located at Parc Eurasanté, 3 rue du Professeur Laguesse, 59000 Lille, France.

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), April 5, 2024 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced the filing of its 2023 Universal Registration Document with the Autorité des marchés financiers (AMF ; filing n° D.24-0246) and its Annual Report on Form 20-F for the year ended December 31, 2023 with the U.S. Securities and Exchange Commission (SEC).

Lille, France; Cambridge, MA; Zurich, Switzerland; April 4, 2024 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced annual financial results for the year ended December 31, 2023. A summary of the consolidated financial statements is included below.

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), February 29, 2024 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced its cash position as of December 31, 2023 and revenues for 2023.

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), January 15, 2024 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced its provisional financial calendar for 2024.

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), December 8, 2023 – GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announces its revised outlook for 2024 and reflects on recent progress.

Paris (France), December 07, 2023 – Ipsen (Euronext: IPN; ADR: IPSEY) and GENFIT (Nasdaq and Euronext: GNFT) today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for investigational elafibranor. An oral, once-daily dual peroxisome activated receptor alpha/delta (PPAR α,δ) agonist, investigational elafibranor could potentially be the first novel second-line treatment for the rare, cholestatic liver disease, PBC, in nearly a decade. The target FDA PDUFA date under priority review is June 10, 2024.

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), December 6, 2023- GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced the publication in the Journal of Hepatology2 of a paper on the performance of NIS2+™ as a screening tool for the enrollment of patients in Metabolic Dysfunction–Associated Steatohepatitis (MASH) clinical trials.

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), November 16, 2023 – GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced the highlights from its “ACLF Day” held on November 11, 2023 during AASLD The Liver Meeting ® in Boston, MA (USA).

Paris (France), November 13, 2023 – Ipsen (Euronext: IPN; ADR: IPSEY) and GENFIT (Nasdaq and Euronext: GNFT) today announced full results from the pivotal Phase III ELATIVE® trial, which are being presented in a late-breaking oral session (Abstract #484, Monday, 13 November at 16.45 EST) at the American Association for the Study of Liver Diseases (AASLD) and simultaneously published in New England Journal of Medicine (NEJM). This trial evaluated the efficacy and safety of investigational elafibranor, an oral, dual PPAR α,δ agonist, as a potential novel class of treatment for patients with the rare, autoimmune cholestatic liver disease, Primary Biliary Cholangitis (PBC).

Lille (France); Cambridge (Massachusetts, United States); Zurich (Switzerland); November 9, 2023 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced its cash position as of September 30, 2023 and revenue for the first nine months of 20231.

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), November 2 2023 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and severe liver diseases, today announced that it will present an update on its scientific and corporate progress at The Liver Meeting® 2023 organized by the American Association for the Study of Liver Diseases (AASLD), which will take place in Boston, MA (USA) from November 10-14, 2023.

Lille (France); Cambridge (Massachusetts, United States); Zurich (Switzerland); September 26, 2023 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and severe liver diseases, today announced the publication of data demonstrating the effectiveness of its non-alcoholic steatohepatitis (NASH)1 diagnostic technology NIS4® by the FNIH’s2 NIMBLE3 project in the scientific journal, Nature Medicine4.

Lille (France), Cambridge (Massachusetts, United States), (Zurich, Switzerland); September 20, 2023 – GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and severe liver diseases, today announced its first half-year 2023 financial results and provided a corporate update.

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), September 05, 2023 – GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and severe liver diseases, today announced that it will participate in the following upcoming investor conferences.

Lille (France); Cambridge (Massachusetts, United States); Zurich (Switzerland); August 10, 2023 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and severe liver diseases, today announced the publication of new data on the clinical performance of NIS2+™ in older patients, for the detection of at-risk nonalcoholic steatohepatitis (NASH) in Hepatology Communications1.

Lille (France); Cambridge (Massachusetts, United States); Zurich (Switzerland); June 7, 2023 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and severe liver diseases, today announced that it will present new data at the EASL Congress which will take place on June 21-24, 2023 in Vienna, Austria.

Lille (France); Cambridge (Massachusetts, United States); Zurich (Switzerland); May 31, 2023 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and severe liver diseases characterized by high unmet medical needs, today announced it has licensed the exclusive worldwide rights of ASK1 Inhibitor SRT-015 (injectable formulation in acute liver disease2) from Seal Rock Therapeutics, a Seattle, Washington (USA) based clinical stage company developing first-in-class and best-in-class kinase inhibitors.

Lille (France); Cambridge (Massachusetts, United States); Zurich (Switzerland); May 24, 2023 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and severe liver diseases, today announced the results of the Combined Shareholders Meeting which took place on May 24, 2023. The quorum on first convening amounted to 29.54% and shareholders approved all of the resolutions, with the exception of resolution n°26 which was rejected in accordance with the recommendations of the Board of Directors.

Lille (France); Cambridge (Massachusetts, United States); Zurich (Switzerland); May 23, 2023 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and severe liver diseases, today announced the publication of the development and validation of NIS2+™ in the Journal of Hepatology.1

Lille (France); Cambridge, (Massachusetts, United States); Zurich (Switzerland); May 11, 2023 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and severe liver diseases, today announced its cash position as of March 31, 2023 and revenues for the first three months of 20231.

Lille (France); Cambridge (Massachusetts, United States); Zurich (Switzerland); May 9, 2023 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and severe liver diseases, today announced that it is presenting Phase 1 clinical data evaluating NTZ as part of its Acute-on-Chronic Liver Failure (ACLF) Program at Digestive Disease Week®, taking place from May 6-9, 2023 in Chicago, Illinois (USA).

GENFIT Announces Publication of Extra-Financial Performance Report 2022

Lille (France); Cambridge (Massachusetts, United States); Zurich (Switzerland); April 19, 2023 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with severe chronic liver diseases, today announced that it published in the April 19, 2023 French legal announcements bulletin n°47 (Bulletin des Annonces Légales Obligatoires) its convening notice that the Combined Shareholders Meeting will be held on May 24, 2023, at 10:00am (CET), at the Faculty of Pharmaceutical Sciences in Lille, located at Parc Eurasanté, 3 rue du Professeur Laguesse, 59000 Lille, France.

Lille (France); Cambridge (Massachusetts, United States); Zurich (Switzerland); April 18, 2023 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with severe chronic liver diseases, today announced the filing of its 2022 Universal Registration Document with the Autorité des marchés financiers (AMF) and its Annual Report on Form 20-F for the year ended December 31, 2022 with the U.S. Securities and Exchange Commission (SEC).

Lille (France); Cambridge (Massachusetts, United States); Zurich (Switzerland); April 13, 2023 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with severe chronic liver diseases characterized by high unmet medical needs, today announced annual financial results for the year ended December 31, 2022. A summary of the consolidated financial statements is included further below.

Lille (France); Cambridge (Massachusetts, United States); Zurich (Switzerland); February 28, 2023 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with liver diseases characterized by high unmet medical needs, today announced its cash position as of December 31, 2022 and revenues for 2022. 1 2

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland) January 24, 2023 – GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with liver diseases characterized by high unmet medical needs, today announced its provisional financial calendar for 2023.

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland) January 5, 2023 – GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with liver diseases characterized by high unmet medical needs, today announced that management will participate in upcoming investor conferences.

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland) November 17, 2022 – GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with liver diseases characterized by high unmet medical needs, today announced the highlights from its Pipeline Day events reviewing the Company’s clinical progress and recent strategic updates.

Lille, France; Cambridge, MA; November 10, 2022 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with severe chronic liver diseases, today announced its cash position as of September 30, 2022 and revenue for the first nine months of 20221.

Lille (France), Cambridge (Massachusetts, United States), October 25, 2022 – GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with severe chronic liver diseases, today announced that it has developed NIS2+™, a next-generation technology for the diagnosis of at-risk Non-Alcoholic Steatohepatitis (NASH), and will be presenting results on NIS2+™‘s clinical performance in three poster presentations at The Liver Meeting® 2022 organized by the American Association for the Study of Liver Diseases (AASLD).

Lille (France), Cambridge (Massachusetts, United States), September 29, 2022 – GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with severe chronic liver diseases, today announced the signing of the Share Purchase Agreement and the completion of its acquisition of Versantis AG (“Versantis”) under the terms announced in its press release on September 19, 2022.

Lille (France), Cambridge, MA; September 28, 2022 – GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with severe and chronic liver diseases, today announced its first half-year 2022 financial results and provided a corporate update.