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GENFIT — Investor Relations & Filings

Ticker · GNFT ISIN · FR0004163111 LEI · 969500XPWN2DMZQA5X73 PA Professional, scientific and technical activities
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Filings indexed 679 across all filing types
Latest filing 2024-01-11 Capital/Financing Update
Country FR France
Listing PA GNFT

About GENFIT

https://www.genfit.com

GENFIT is a biopharmaceutical company dedicated to developing therapeutic and diagnostic solutions for patients with rare and severe liver diseases characterized by high unmet medical needs. The company's primary focus is on Acute-on-Chronic Liver Failure (ACLF) and its associated conditions, such as acute decompensation (AD) and hepatic encephalopathy (HE). Leveraging a scientific heritage of over two decades, GENFIT is a pioneer in liver disease research and development, aiming to improve the lives of patients with these life-threatening conditions.

Recent filings

Filing Released Lang Actions
GENFIT: Half-Year Report of Liquidity Contract with Crédit Industriel et Commercial
Capital/Financing Update Classification · 99% confidence The document is titled "GENFIT: Half-Year Report of Liquidity Contract with Crédit Industriel et Commercial" and provides detailed figures regarding shares and monetary values held on a liquidity account as of December 31, 2023, covering trading activity during the second half of 2023. This content specifically relates to the management of the company's own shares (buybacks/stabilization) under a contract, which aligns directly with the definition of 'Transaction in Own Shares' (POS). Although it mentions 'Half-Year Report', the content is not a comprehensive financial report (like IR or 10-K) but a specific disclosure about share transactions/holdings related to liquidity management. Therefore, POS is the most appropriate classification.
2024-01-11 English
GENFIT : Perspectives 2024 actualisées suite à la validation des dépôts de demandes d’autorisation d’élafibranor dans la Cholangite Biliaire Primitive (PBC)
Regulatory Filings Classification · 95% confidence The document is a press release dated December 8, 2023, from GENFIT, announcing updated 2024 perspectives following the validation of regulatory submissions (NDA/MMA) for their drug élafibranor in Primary Biliary Cholangitis (PBC). It details regulatory milestones (FDA Priority Review, PDUFA date June 10, 2024), expected milestone payments, and updates on their broader pipeline (ACLF focus). This content is characteristic of an announcement providing key financial and operational updates related to drug development progress and expected near-term revenue triggers, rather than a full annual report (10-K), a quarterly report (IR), or just a simple dividend/share transaction notice. It is a comprehensive update on business progress and financial outlook, which aligns best with an Earnings Release (ER) or a general announcement that updates investors on key operational achievements and financial expectations. Given the focus on updated financial outlooks triggered by regulatory events, 'Earnings Release' (ER) is the most appropriate classification, even though it's not strictly tied to a quarterly earnings report date, as it serves the function of updating investors on key financial milestones and outlook. It is not a DEF 14A (Remuneration), DIRS (Director's Dealing), or DIV (Dividend Notice). It is too detailed to be a simple Report Publication Announcement (RPA). It is a substantive update on business progress and financial expectations.
2023-12-08 French
GENFIT Updates 2024 Outlook Following Acceptance of Elafibranor Filings in Primary Biliary Cholangitis (PBC)
Regulatory Filings Classification · 95% confidence The document is a press release from GENFIT dated December 8, 2023, announcing updates regarding the regulatory acceptance (FDA Priority Review, EMA validation) and outlook for their drug elafibranor in PBC. It discusses financial milestones, pipeline progress (ACLF franchise), and includes standard sections like 'Forward Looking Statements' and 'Contact Information'. This format—a formal announcement of significant business/clinical progress, often including financial guidance updates—is characteristic of an Earnings Release (ER) or a general press release that updates investors on key operational milestones. Since it focuses heavily on updating the 2024 outlook based on recent regulatory achievements and pipeline progress, it aligns best with the 'Earnings Release' (ER) definition, which covers initial announcements of periodical financial results and key highlights, even if it's not strictly tied to a quarterly earnings report date. It is not a full 10-K, an Investor Presentation (IP), or a Call Transcript (CT). Given the focus on updating the outlook and recent progress triggers, ER is the most appropriate fit among the provided options.
2023-12-08 English
Ipsen confirms U.S. FDA grants priority review for New Drug Application for elafibranor for the treatment of rare cholestatic liver disease, PBC
Regulatory Filings Classification · 100% confidence The document is a press release from Ipsen and GENFIT announcing that the U.S. FDA has granted Priority Review for the New Drug Application (NDA) for elafibranor, setting a PDUFA date of June 10, 2024. It also mentions validation of the Marketing Authorization Application (MAA) by the EMA and MHRA. This type of announcement, detailing regulatory milestones (acceptance, priority review, PDUFA dates) for a drug candidate, is characteristic of a corporate communication regarding clinical/regulatory progress, rather than a full financial report (10-K, IR) or a general earnings release (ER). Since it is a specific announcement about regulatory progress and clinical trial data (ELATIVE study), it fits best under the general category of Investor Presentation (IP) or Regulatory Filings (RNS). Given the detailed nature of the clinical data summary and the focus on regulatory status, 'Investor Presentation' (IP) is a strong candidate as these press releases often serve as investor updates. However, since it is a formal press release announcing regulatory actions, and 'IP' often implies a slide deck, 'Regulatory Filings' (RNS) serves as a robust category for significant, non-financial regulatory updates that don't fit other specific codes. Given the context of major regulatory milestones being announced, and the document being a press release detailing these events, it is most accurately classified as a general Regulatory Filing/Announcement (RNS) or potentially an Investor Presentation (IP). Since the content is a formal announcement of regulatory progress and clinical trial results, which is a key part of investor relations communication, I will lean towards Investor Presentation (IP) as it contains substantial scientific/clinical detail, which is common in investor decks, although RNS is also plausible. Given the depth of the clinical data summary (ELATIVE trial results), IP is slightly more fitting than the general RNS fallback.
2023-12-07 English
Ipsen confirme la décision de la FDA d'accorder un examen prioritaire pour le dépôt du dossier de demande d'autorisation d'elafibranor dans le traitement de la cholangite biliaire primitive, une malad
Regulatory Filings Classification · 100% confidence The document is a press release dated December 7, 2023, issued jointly by Ipsen and GENFIT. The content focuses on the FDA accepting the New Drug Application (NDA) for elafibranor for Primary Biliary Cholangitis (PBC), confirming the PDUFA date, and noting validation by the EMA and MHRA. This is an announcement regarding regulatory progress and clinical trial results (Phase III ELATIVE study mentioned). This type of announcement, detailing regulatory milestones and clinical data updates outside of a formal quarterly/annual report, is best classified as an Earnings Release (ER) if it were focused on financial results, but since it is purely focused on drug development and regulatory acceptance, it fits best under the general category for significant corporate news that isn't a specific financial filing or presentation. However, given the options, this is a major corporate announcement regarding drug development progress and regulatory submissions. It is not a full financial report (10-K, IR), a transcript (CT), or a presentation (IP). It is a press release announcing key operational/regulatory news. In the context of financial filings, major operational updates like this often accompany or precede formal earnings releases, but since it is a standalone announcement of regulatory progress, it is most closely aligned with an Earnings Release (ER) which often includes operational highlights, or potentially a Regulatory Filing (RNS) if it were less detailed. Given the detail about FDA/EMA acceptance and PDUFA dates, it functions as a significant corporate update, often grouped with ERs. Since it is a detailed announcement of a major corporate event (regulatory acceptance), and not just a notice that a report is available (RPA), ER is the most appropriate fit among the choices for a major operational/pipeline update press release.
2023-12-07 French
GENFIT annonce une publication dans le Journal of Hepatology sur la performance et la précision de NIS2+™ en tant qu’outil de screening pour le recrutement des patients dans les essais cliniques MASH
Regulatory Filings Classification · 100% confidence The document is a press release from GENFIT announcing the publication of study results regarding their NIS2+™ technology in the *Journal of Hepatology*. It details clinical findings, quotes experts, provides background on MASH, and includes standard forward-looking statements and contact information typical of a corporate announcement. This type of announcement, which communicates key business or scientific developments outside of mandatory periodic financial reports (like 10-K or IR), is best classified as a general Regulatory Filing (RNS) or potentially an Investor Presentation (IP) if it were structured as slides, but given the format and content focus on a specific scientific/business update, RNS is the most appropriate general regulatory announcement category, as it is not an Earnings Release (ER), a formal Audit Report (AR), or a specific financing/dividend notice. It is not a short announcement linking to a full report, so RPA is less likely than RNS for this substantive content.
2023-12-06 French

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