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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 681 across all filing types
Latest filing 2019-06-04 Regulatory Filings
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: GENFIT Launches a Phase 2 Trial Evaluating Elafibranor on Hepatic Lipid Composition for NAFL
Regulatory Filings Classification · 95% confidence The document is a press release from GENFIT dated June 04, 2019, announcing the launch of a Phase 2 clinical trial for their drug elafibranor. It details the study objectives, methodology (randomized, placebo-controlled, double-blind, cross-over), and quotes company executives and external experts regarding the scientific rationale. This content structure—announcement of a specific corporate/clinical event, key highlights, quotes, and forward-looking statements—is characteristic of an Earnings Release (ER) or a general press release announcing significant operational news. Since it is not a full financial report (10-K, IR), a transcript (CT), or a formal regulatory filing like a proxy statement, the most appropriate classification for a major operational announcement that is not explicitly a financial results release is often a general Regulatory Filing (RNS) or, given the focus on clinical trial updates, sometimes an Investor Presentation (IP) if it were structured as slides. However, as a formal press release announcing a clinical trial launch and providing detailed scientific context, it functions as a significant corporate update. Given the options, and recognizing that many clinical/operational updates are categorized broadly, I will check if it fits better elsewhere. It is not a formal 'Earnings Release' (ER) which focuses on financial results. It is not a 'Management Report' (MDA) which explains financial results. It is a specific announcement about R&D progress. In many databases, such detailed operational announcements that are not financial results are often classified as Regulatory Filings (RNS) if they are mandatory disclosures, or sometimes Investor Presentation (IP) if the format suggests it. Since this is a press release announcing a trial launch, and it doesn't fit the specific definitions for ER, IR, or IP well (it's not a presentation deck), RNS (General regulatory announcements/fallback) is a strong candidate. However, given the depth of scientific and clinical detail, it strongly resembles material that would be presented to investors, making IP plausible, but it is explicitly a press release. Since it is a detailed announcement of a significant corporate event (clinical trial launch) that is not a financial report, and it is not a short announcement linking to a report (RPA), I will classify it as a general Regulatory Filing (RNS) as it is a formal public disclosure of material information, which serves as the best fit among the provided non-financial categories for a detailed operational update press release.
2019-06-04 English
Genfit: GENFIT Launches a Combination Therapy Clinical Program in NASH
Regulatory Filings Classification · 95% confidence The document is a press release dated May 23, 2019, announcing the launch of a combination therapy clinical program for NASH using the lead asset, elafibranor. It details scientific rationale, planned trial design (proof of concept study starting in 2H19), and includes forward-looking statements and contact information typical of corporate news releases. This content aligns best with an Earnings Release (ER) if it were summarizing financial results, but since it is a specific operational/pipeline update, it is most accurately classified as a general corporate announcement. Given the options, and since it is not a formal regulatory filing like a 10-K, nor a transcript (CT), nor a presentation (IP), it functions as an announcement of corporate activity. However, press releases announcing significant operational milestones, especially in the biotech/pharma sector, are often categorized under Earnings Release (ER) if they are the primary means of disseminating period-specific news, or sometimes as Regulatory Filings (RNS) if they are mandatory disclosures. Since this is a proactive announcement about a clinical program launch, and not a summary of financial performance (ER) or a general regulatory filing (RNS), it is a specific corporate update. In the context of the provided definitions, it is a specific corporate announcement that doesn't fit perfectly into the financial reporting categories (10-K, IR, MRQ). It is not a proxy statement (DEF 14A), dividend notice (DIV), or management discussion (MDA). Given the nature of announcing clinical trial progress, it is often grouped with other non-financial, material news. Since there is no specific 'Press Release' or 'Corporate Update' code, and it is not a report itself, the closest fit among the provided options for a material, non-financial announcement that isn't explicitly covered elsewhere is often RNS (Regulatory Filings - general fallback) or potentially ER if it's the main communication vehicle for the period's news, but ER is defined as 'Initial announcement of quarterly/periodical financial results (key highlights only)'. This document focuses purely on R&D strategy. Therefore, RNS (Regulatory Filings / General Announcement) is the most appropriate fallback for this material corporate news item.
2019-05-23 English
GENFIT : Issue positive du DSMB à 36 mois, recommandant la poursuite de l’étude clinique de Phase 3 RESOLVE-IT évaluant elafibranor dans la NASH
Legal Proceedings Report Classification · 99% confidence The document is a press release dated May 14, 2019, announcing a positive recommendation from the Data Safety Monitoring Board (DSMB) for the continuation of the Phase 3 clinical trial (RESOLVE-IT) evaluating elafibranor for NASH. It discusses clinical trial progress, safety profiles, potential future regulatory submissions (FDA/EMA), and provides company background. This type of announcement, focusing on clinical trial milestones and safety updates, is characteristic of communications aimed at investors and the market regarding ongoing drug development. It is not a full Annual Report (10-K), an Earnings Release (ER), or a formal Audit Report (AR). Since it is a specific announcement about clinical trial status and safety, it fits best under the general category of Investor Information or a specific regulatory/clinical update. Given the options, this is a specific corporate update related to R&D progress, which often falls under general Regulatory Filings (RNS) if no other specific category fits perfectly. However, it is a detailed update on a key corporate activity (clinical trial progression) that is not a financial report, management change, or dividend notice. It is most closely aligned with a general corporate announcement, making RNS the most appropriate fallback, although it contains elements of an Investor Presentation (IP) in its structure, it is presented as a press release, not a slide deck. Given the options, RNS (Regulatory Filings/General Announcement) is the best fit for a press release detailing clinical trial progress that isn't explicitly an ER, IR, or CAP update.
2019-05-14 French
GENFIT: Positive 36-month DSMB Recommendation for Continuation of Phase 3 RESOLVE-IT Study of Elafibranor in NASH
Regulatory Filings Classification · 100% confidence The document is a press release dated May 14, 2019, announcing that the Data Safety Monitoring Board (DSMB) recommended the continuation of the Phase 3 RESOLVE-IT clinical trial for Elafibranor in NASH without modification, based on a safety review. This type of announcement, detailing clinical trial progress, safety updates, and future milestones (like expected top-line results), is characteristic of an Earnings Release (ER) or a general press release related to operational updates. Since it is not a full financial report (10-K or IR), a transcript (CT), or a formal regulatory filing like a proxy statement, the most appropriate classification for a key operational/clinical update released to the public and investors is 'Earnings Release' (ER), as these often accompany or precede formal earnings reports and contain forward-looking statements and operational highlights. It is a direct announcement of a significant operational event, not just a notice that a report is available (RPA/RNS).
2019-05-14 English
GENFIT: Ordinary Shareholder’s Meeting of June 13, 2019 – Availability of Preparatory Documents
AGM Information Classification · 93% confidence The document is explicitly titled 'PRESS RELEASE' and announces the 'Availability of Preparatory Documents' for an 'Ordinary Shareholder's Meeting' scheduled for June 13, 2019. It details where the meeting materials are available and mentions the process for voting (VOTACCESS platform). This document is not the full AGM presentation (AGM-R), nor is it the official voting results (DVA). It is an announcement concerning an upcoming shareholder meeting and the associated documentation. Since it is a formal announcement related to a shareholder meeting, and the primary focus is on the availability of materials for that meeting, it most closely aligns with the general category of shareholder/proxy information, but given the specific context of announcing the meeting and the availability of documents, it functions as a precursor to the AGM or a related notice. However, looking at the definitions, 'AGM-R' is for presentations/materials shared *during* the meeting. This document is an announcement *before* the meeting about the availability of documents. It is a formal notice related to the meeting. If it were solely about the voting instructions/proxy materials, PSI might fit, but it's broader. Since it is a press release announcing the details and availability of materials for the AGM, and it is not a full report, the closest fit among the specific options is often related to the meeting itself or a general regulatory announcement. Given the strong focus on the upcoming Shareholders' Meeting, and the fact that it is a press release announcing the availability of preparatory documents, it is best classified as related to the AGM process. If a specific 'Meeting Notice' code existed, it would be used. In the absence of a specific 'Meeting Notice' code, and considering it's a formal announcement about the meeting logistics and documentation, it is often grouped with AGM-related filings. However, since it is a press release announcing the availability of documents, and not the documents themselves, and it doesn't fit perfectly into AGM-R (which implies materials *from* the meeting), it could be RNS. Let's re-evaluate: The core subject is the Ordinary Shareholder's Meeting. The document serves to convene shareholders and inform them where to find the preparatory documents. This is highly related to the AGM. If we must choose the most specific category related to the event, AGM-R is the closest thematic fit, even if it's a pre-meeting announcement. If we strictly follow the 'Menu vs Meal' rule, and this is an announcement *about* the materials, it leans towards RPA or RNS. Since it is a formal announcement about the AGM, and not just a generic regulatory filing, I will classify it as AGM-R, interpreting it as the official notice/material related to the AGM, as it is more specific than RNS or RPA. The document length (6052 chars) is substantial enough that it's not just a brief link announcement, but a full press release detailing the event. I will stick with AGM-R as the most relevant thematic classification for an announcement concerning the Ordinary Shareholder's Meeting.
2019-05-10 English
GENFIT : Assemblée générale ordinaire du 13 juin 2019 – modalités de mise à disposition des documents préparatoires
AGM Information Classification · 95% confidence The document is explicitly titled "COMMUNIQUÉ DE PRESSE" (Press Release) and announces details regarding the upcoming Annual General Meeting ("Assemblée générale ordinaire du 13 juin 2019"). It informs shareholders about the availability of preparatory documents and the procedures for voting. Since the document's primary function is to announce the meeting details and the availability of related materials, it strongly relates to the AGM process. However, the core content is an announcement *about* the AGM and the associated documentation, rather than the voting results (DVA) or the proxy materials themselves (PSI). Given the options, this announcement serves as a general notice related to the AGM. While it is a press release, the specific subject matter points towards AGM information. If the document were the actual presentation or minutes, AGM-R would be perfect. Since it is an announcement concerning the AGM logistics and document availability, and it is not a standard regulatory filing like 10-K or IR, it fits best under AGM-R as it pertains directly to the meeting, or potentially RPA if it were purely announcing the release of other documents. Because the focus is the AGM itself, AGM-R is the most specific fit for the subject matter, even though it's structured as a press release.
2019-05-10 French

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