Iqirvo® (elafibranor)

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Genfit: Half-Year Report of Liquidity Contract with Crédit Industriel et Commercial
Globenewswire· 2025-07-08 20:10
Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), July 8, 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 half-year report of the liquidity contract with Crédit Industriel et Commercial. Under the liquidity contract GENFIT has with Crédit Industriel et Commercial, the following resources appeared on the liquidity account as of June 30, 2025: 201 ...
GENFIT Reports First Quarter 2025 Financial Information
Globenewswire· 2025-05-22 20:10
Core Viewpoint - GENFIT reported a significant increase in cash position and revenues for the first quarter of 2025, driven by a non-dilutive royalty financing agreement and royalties from Iqirvo® sales, indicating a strong financial outlook for the company. Cash Position - As of March 31, 2025, the company's cash and cash equivalents were €129.5 million, up from €74.0 million on March 31, 2024, and €81.8 million on December 31, 2024 [2][3] - The increase in cash is attributed to a €130.0 million first installment from a royalty financing agreement with HCRx, offset by the repurchase of OCEANEs totaling €61.7 million [3] Revenues - Revenues for the first three months of 2025 were €2.8 million, compared to €1.1 million for the same period in 2024, reflecting a substantial growth [4] - The revenue increase is primarily due to royalties from Iqirvo® (elafibranor) sales from Ipsen [4] Corporate Governance Update - Chief Medical Officer Carol Addy will retire effective June 30, 2025, with a replacement to be announced later [6] - CEO Pascal Prigent expressed gratitude for Addy's contributions to the company [6] Company Overview - GENFIT is focused on developing treatments for rare and life-threatening liver diseases, with a strong emphasis on Acute-on-Chronic Liver Failure (ACLF) [7] - The company has a diversified R&D portfolio, including multiple assets under development targeting various liver diseases and related conditions [8][9]
GENFIT to receive a €26.5 million milestone payment following the approval of pricing and reimbursement of Ipsen’s Iqirvo® in Italy
Globenewswire· 2025-05-20 20:10
Core Viewpoint - GENFIT has announced that Ipsen's Iqirvo® has received pricing and reimbursement approval in Italy for Primary Biliary Cholangitis (PBC), marking a significant milestone for the company [1][2]. Group 1: Financial Impact - The approval in Italy triggers a milestone payment of €26.5 million under the Licensing and Collaboration Agreement with Ipsen, which is due upon pricing and reimbursement in three major European markets [2]. - This payment will support the advancement of GENFIT's pipeline focused on Acute On-Chronic Liver Failure (ACLF) and other serious diseases [2]. Group 2: Company Overview - GENFIT is a biopharmaceutical company dedicated to addressing unmet medical needs in patients with rare and life-threatening liver diseases, with over two decades of research and development experience [3]. - The company has a diversified R&D portfolio, including five assets under development for ACLF and other serious diseases such as cholangiocarcinoma, urea cycle disorder, and organic acidemia [3]. - GENFIT has successfully achieved accelerated approval for Iqirvo® (elafibranor) from major regulatory agencies, including the U.S. FDA and the European Medicines Agency [3]. Group 3: Strategic Partnerships - Ipsen became one of GENFIT's largest shareholders in 2021, acquiring an 8% stake in the company, indicating a strong partnership and commitment to the collaboration [3].
GENFIT: Publication of the 2025 Extra-Financial Performance Report (fiscal year 2024)
Globenewswire· 2025-05-14 20:10
Core Viewpoint - GENFIT has published its 2025 Extra-Financial Performance Report, highlighting its commitment to sustainable development and corporate social responsibility (CSR) in the biopharmaceutical sector, particularly focusing on rare and life-threatening liver diseases [1][2][3] Company Commitment to ESG - The establishment of a dedicated ESG Committee in 2021 has led to a structured approach to sustainability, with an annual roadmap translating into concrete actions and monitoring of key indicators [3] - In 2024, GENFIT enhanced its social and environmental responsibility efforts, including increased patient engagement and initiatives for gender equality in the workplace [3][4] - The company is preparing a compliance plan for non-financial reporting under the CSRD framework, despite the suspension of its transition plan to ESRS standards due to regulatory developments [3] Patient and Employee Engagement - GENFIT's initiatives, such as a breast cancer prevention campaign, demonstrate its commitment to improving the quality of life and working conditions for employees [5] - Patient advocacy efforts, particularly in the area of Acute-on-Chronic Liver Failure (ACLF), reflect the company's dedication to developing treatments that significantly improve patient lives [5] Long-term Value Creation - GENFIT recognizes the correlation between long-term financial performance and extra-financial performance, emphasizing the societal impact of its R&D programs and governance practices [6][7] - The company aims to create meaningful long-term value for patients, healthcare systems, employees, and shareholders through its commitment to innovative therapeutic solutions [7] Company Overview - GENFIT is a late-stage biopharmaceutical company focused on rare liver diseases, with a diverse and expanding R&D portfolio, including five assets under development for ACLF [8] - The company has a history of successful drug approvals, including Iqirvo® (elafibranor) for Primary Biliary Cholangitis, showcasing its expertise in drug development [8]