Genfit - ADR

Genfit SA is a biopharmaceutical company involved in drug discovery and development for the early diagnosis, prevention and treatment of cardiometabolic diseases. The company focuses on the discovery and development of drug candidates in areas of high unmet medical needs corresponding to a lack of suitable treatments. It focuses on medicines to market for patients with metabolic, inflammatory, autoimmune and fibrotic diseases that affect the liver. The company was founded by Jean-François Mouney, Florence Séjourné, and Bart Staels in September 1999 and is headquartered in Loos, France.

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.

GENFIT Announces Corporate Updates and Upcoming Participation at The Liver Meeting® 2024

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.

GENFIT Reports Third Quarter 2024 Financial Information

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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 .

GENFIT: Ipsen's Iqirvo® (Elafibranor) Receives EU Approval as a First-in-Class Treatment for Primary Biliary Cholangitis following U.S. FDA Accelerated Approval

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.

GENFIT: Positive Opinion from EMA Committee for Ipsen's Iqirvo® (elafibranor) in Primary Biliary Cholangitis

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland) July 9, 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 half-year report of the liquidity contract with Crédit Industriel et Commercial.

GENFIT: Half-Year Report of Liquidity Contract with Crédit Industriel et Commercial

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).

GENFIT: New EASL-EASD-EASO Clinical Practice Guidelines for MASLD Include NIS2+® as Key Tool for Detecting At-Risk MASH

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.

GENFIT: Historic Milestone Achieved with U.S. FDA Accelerated Approval of Ipsen's Iqirvo® for Primary Biliary Cholangitis

The U.S. Food and Drug Administration has approved French drugmakers Ipsen and Genfit's drug to treat a chronic inflammatory liver disease, Ipsen said on Monday.

US FDA approves Genfit and Ipsen's liver disease drug

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.

GENFIT to Present Latest ACLF Research at EASL Congress™ 2024

Genfit S.A. has a PDUFA date of June 10, 2024, by which time the FDA will decide upon whether elafibranor should be approved to treat patients with primary biliary cholangitis. European marketing approval of elafibranor for treatment of patients with primary biliary cholangitis is also possible; Expected to happen in 2nd half of 2024. Interim results from the phase 2 UNVEIL-IT study, using VS-01 for the treatment of patients with acute chronic liver failure, expected in the 2nd half of 2024.

Genfit: Under The Radar Biotech With Upcoming Catalysts

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.

GENFIT: May 22, 2024 Combined Shareholders Meeting Results

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

GENFIT Reports First Quarter 2024 Financial Information

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).

GENFIT: Publication of the 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.

GENFIT Annual Combined General Meeting of May 22, 2024 — Availability of Preparatory Documents

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).

GENFIT Announces Publication of the 2023 Universal Registration Document and the 2023 Annual Report on Form 20-F

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.

GENFIT Reports Full-Year 2023 Financial Results and Provides Corporate Update

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.

GENFIT Announces Revenues and Cash Position as of December 31, 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.

GENFIT Announces 2024 Financial Calendar

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.

GENFIT Updates 2024 Outlook Following Acceptance of Elafibranor Filings in Primary Biliary Cholangitis (PBC)

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 Hepatology 2 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.

GENFIT Announces Publication in the Journal of Hepatology on the Accurate Performance of NIS2+™ as a Screening Tool for the Enrollment of Patients in MASH Clinical Trials

Genfit is close to possible approval for its drug team-up with Ipsen, with positive Phase 3 readouts having been achieved. The company focuses on developing therapeutic products for liver diseases, currently with a primary focus on Primary Biliary Cholangitis (PBC). Genfit's cash situation is decent, with most of its debt being convertible and maturing in a distant enough future, giving the company time for key approvals.

Genfit: Large PBC Market, Liquidity To Await Approval

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).

GENFIT Highlights ACLF Development Strategy at “ACLF Day” during AASLD The Liver Meeting® 2023

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).

GENFIT: Results from Ipsen's ELATIVE® pivotal Phase III trial of elafibranor in PBC presented as late breaking data at AASLD congress and published in New England Journal of Medicine

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.

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