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ABIVAX — Investor Relations & Filings

Ticker · ABVX ISIN · FR0012333284 LEI · 969500D8TMNB184OJU95 PA Manufacturing
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Filings indexed 872 across all filing types
Latest filing 2021-09-15 Share Issue/Capital Cha…
Country FR France
Listing PA ABVX

About ABIVAX

https://www.abivax.com

Abivax is a clinical-stage biotechnology company developing therapeutics for chronic inflammatory diseases by regulating the immune system. The company's scientific approach is centered on harnessing microRNA (miRNA) biology. Its lead drug candidate, obefazimod, is an investigational, once-daily, oral small molecule with a novel mechanism of action that enhances the expression of miR-124, a natural regulator of the inflammatory response. The primary development program for obefazimod focuses on ulcerative colitis, for which the company has reported positive Phase 3 clinical trial results. Abivax is also investigating the candidate for the treatment of Crohn's disease and other inflammatory conditions, while exploring follow-on compounds.

Recent filings

Filing Released Lang Actions
ABIVAX: Nombre d'actions composant le capital social et nombre total de droits de vote au 31.08.21.
Share Issue/Capital Change Classification · 1% confidence The document explicitly states it provides 'Informations relatives au nombre total de droits de vote et d'actions prévues par l'article L. 233-8 II du code de commerce et l'article 223-16 du règlement général de l'Autorité des Marchés Financiers.' It presents a table detailing the number of shares and total voting rights as of a specific date (31/08/2021). This type of mandatory disclosure regarding share capital structure and voting rights is a specific regulatory filing requirement in France, often related to major shareholding changes or general capital structure updates. Given the options, this content most closely aligns with a notification about share capital changes or major holdings. Since it details the total number of shares and voting rights, it fits best under Share Issue/Capital Change (SHA) or Major Shareholding Notification (MRQ). Because the focus is on the total count of shares and voting rights, which is a fundamental capital structure metric, SHA is a strong candidate. However, the structure strongly resembles the periodic disclosure required under French regulations (AMF) concerning the total number of shares and voting rights, which is often triggered by crossing thresholds or is a routine update. Given the options, 'Major Shareholding Notification' (MRQ) often encompasses these periodic updates on total voting rights, although 'Share Issue/Capital Change' (SHA) is also plausible. Since the document is a formal, structured disclosure of voting rights and share count, and not a general announcement of a dividend or a management change, and it is not a full report, I will classify it based on the content related to share structure/voting rights. The closest fit among the specific codes for this type of mandatory disclosure is MRQ (Major Shareholding Notification), as these reports often include the total voting rights count, or SHA (Share Issue/Capital Change). Given the context of L. 233-8 II, which relates to disclosure thresholds, MRQ is the most appropriate classification for a periodic update on total voting rights.
2021-09-15 French
Abivax communique des données cliniques supplémentaires et fait le point sur la stratégie de développement d'ABX464 dans la rectocolite hémorragique
Investor Presentation Classification · 1% confidence The document is a press release dated September 14, 2021, detailing clinical data updates for the drug ABX464 in treating Ulcerative Colitis (RCH). It provides detailed efficacy and safety results from Phase 2b and Phase 2a maintenance studies, discusses the mechanism of action, and announces upcoming presentations at a medical conference (UEG Week Virtual 2021). Key indicators: 1. It is a formal announcement of clinical trial results and strategic updates, not a full regulatory filing like a 10-K or a short notice of a report release (RPA/RNS). 2. It contains comprehensive financial/clinical data summaries, which aligns with an Investor Presentation (IP) or a detailed Earnings Release (ER) if it were quarterly results. However, since the focus is purely on clinical development progress, mechanism of action, and future regulatory steps (Phase 3 planning), it functions as a detailed update for investors and the scientific community. 3. It is too detailed and comprehensive to be a simple Earnings Release (ER) which usually focuses on financial performance highlights. 4. It is not a Call Transcript (CT) or a formal Audit Report (AR). 5. Given the depth of scientific and clinical data presentation aimed at investors and stakeholders regarding drug development milestones, the most appropriate classification is Investor Presentation (IP). It serves the purpose of presenting the company's progress and strategy to the investment community, even though it is formatted as a press release.
2021-09-14 French
Abivax provides an update on the ABX464 clinical data and development strategy in ulcerative colitis
Earnings Release Classification · 1% confidence The document is a press release dated September 14, 2021, originating from a company (Abivax) via DGAP-News. It provides an update on clinical trial data (Phase 2b and Phase 2a) for a drug candidate (ABX464) in ulcerative colitis, discusses mechanism of action, and mentions upcoming regulatory consultations (FDA feedback expected by year-end) and presentations at a medical conference (UEG Week). Crucially, the final paragraph states: "Abivax will provide the half-year 2021 financial results as well as an operational update before the end of next week." This indicates the document is an announcement or update related to clinical/operational progress, not the comprehensive financial report itself (like 10-K or IR). Since it details study results, mechanism, and operational strategy updates, it is best classified as an Investor Presentation (IP) or a general Regulatory Filing (RNS). Given the detailed scientific and strategic update aimed at investors, Investor Presentation (IP) is a strong fit, although it lacks the typical slide deck format. However, since it is a news release detailing study results and strategy updates, and it is not a formal quarterly report (IR) or an earnings release (ER) which focuses only on key financial figures, it falls under the broader category of investor communication. Because it is a detailed update on clinical progress and strategy, 'Investor Presentation' (IP) is the most specific fit among the options for this type of detailed scientific/strategic release, even if it's in news format rather than a slide deck. If it were purely a regulatory filing without this level of detail, RNS would be used. Given the depth of data presentation, IP is chosen over RNS. H1 2021
2021-09-14 English
ABIVAX : Nombre d'actions composant le capital social et nombre total de droits de vote
Share Issue/Capital Change Classification · 1% confidence The document is titled 'Nombre d'actions composant le capital social et nombre total de droits de vote' (Number of shares comprising the share capital and total number of voting rights). It explicitly references French regulatory articles (Article L. 233-8 II du code de commerce and Article 223-16 du règlement général de l'Autorité des Marchés Financiers - AMF). The content provides a table detailing the number of shares and voting rights as of a specific date (31/07/2021). This structure is characteristic of mandatory regulatory disclosures concerning share capital structure and voting power, which often fall under general regulatory announcements or specific capital change notifications. Since it is a formal disclosure about the total number of shares and voting rights, it relates closely to capital structure changes or major shareholding notifications, but the most fitting general category for mandatory regulatory updates on share structure that aren't explicitly a dividend, share issue, or director dealing is often captured by the general regulatory filing category or a specific capital/share announcement. Given the options, this is a formal notification about the capital structure and voting rights, which is a specific type of regulatory filing. It is not a full report (10-K, IR), an earnings release (ER), or a dividend notice (DIV). It is most closely related to share structure information. While 'SHA' (Share Issue/Capital Change) is related, this specific report is a periodic disclosure of the *total* outstanding shares and voting rights, often required monthly or quarterly by the AMF, which fits well under a general regulatory filing or a specific capital disclosure. Since it details the total number of shares and voting rights, it is a fundamental piece of information about the company's capital base. However, it is not announcing a *change* (like a new issue or buyback), but rather a snapshot. In many databases, these periodic disclosures of total voting rights are classified under general regulatory filings or sometimes under 'Major Shareholding Notification' (MRQ) if they are triggered by crossing thresholds, but here it seems to be a routine update. Given the options, 'RNS' (Regulatory Filings - general fallback) is appropriate for routine, mandatory regulatory disclosures that don't fit a more specific category like DIV or SHA (which usually implies an *action*). However, since it directly concerns the number of shares, 'SHA' might be considered, but 'SHA' usually implies an issuance or change. Let's re-evaluate: This is a mandatory disclosure under French law regarding the total share count and voting rights. This type of disclosure is often categorized as a general regulatory filing (RNS) or sometimes grouped with capital structure updates. Given the precise nature of the other codes, and that this is a routine regulatory update on the capital base, RNS is the safest general classification if a more specific one isn't perfect. Let's check if it fits MRQ (Major Shareholding Notification). MRQ is for *changes* in significant ownership. This document reports the total, which is often published alongside threshold crossing reports. Since it is a formal regulatory disclosure mandated by the AMF, RNS is the most appropriate fallback for this specific type of mandatory capital structure disclosure that isn't an active transaction (like SHA or POS). I will classify it as RNS.
2021-09-02 French
Abivax reçoit l'autorisation pour la conduite d'une étude de phase 1 chez des volontaires sains japonais afin d'inclure le Japon dans son programme global de phase 3 dans la rectocolite hémorragique
Regulatory Filings Classification · 1% confidence The document is a press release dated August 17, 2021, announcing that the Japanese PMDA has approved a Phase 1 clinical trial for ABX464 in Japanese healthy volunteers. It discusses clinical development plans (Phase 3 inclusion), upcoming results from other studies (Phase 2b, TQT, DDI, ADME), and provides company background and contact information. This type of announcement, detailing clinical trial progress, regulatory milestones, and future development timelines, is characteristic of an Earnings Release (ER) or a general press release related to operational updates. Since it focuses on key operational and clinical progress rather than being a full financial report (10-K/IR) or a transcript (CT), the most appropriate classification among the provided options is 'Earnings Release' (ER), as these releases often contain the most recent operational highlights, even outside of formal quarterly reporting periods. It is not a formal regulatory filing like a 10-K or IR, nor is it a simple announcement of a report publication (RPA).
2021-08-17 French
Abivax receives approval for ABX464 phase 1 study in Japanese subjects for subsequent inclusion of Japan into the global phase 3 program in ulcerative colitis
Regulatory Filings Classification · 1% confidence The document is a news release dated August 17, 2021, announcing regulatory approval from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for a Phase 1 clinical trial of ABX464. It details clinical development plans, expected timelines, and mentions upcoming Phase 2b top-line data. This type of announcement, focusing on clinical trial progress, regulatory milestones, and future development plans, is characteristic of communications aimed at investors and regulators regarding ongoing operations, but it is not a formal financial report (like 10-K or IR) nor a transcript (CT). Since it is a specific corporate announcement about clinical progress and regulatory steps, it fits best under the general 'Regulatory Filings' (RNS) category as a broad corporate news release, or potentially 'LTR' if it were about a legal proceeding, but here it is about clinical trial approval. Given the options, 'RNS' (Regulatory Filings/General Announcement) is the most appropriate catch-all for significant operational news that isn't a core financial report or management change.
2021-08-17 English

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