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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 2021-12-01 Regulatory Filings
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 reçoit la réponse de la FDA afin d'avancer le programme clinique de phase 3 d'ABX464 dans la rectocolite hémorragique
Regulatory Filings Classification · 1% confidence The document is a press release dated December 1, 2021, announcing that ABIVAX received feedback from the US FDA following an 'End-of-Phase 2 meeting' regarding the Phase 3 clinical program for ABX464 in ulcerative colitis. This type of announcement, detailing regulatory feedback and next steps for clinical trials, is typically classified as a general corporate or regulatory update. It is not a full financial report (10-K, IR), an earnings release (ER), a management discussion (MDA), or a specific legal filing. Since it is a significant, time-sensitive announcement concerning regulatory progress that doesn't fit the more specific categories like M&A (TAR) or Capital Change (CAP), it best fits the general 'Regulatory Filings' (RNS) category, which serves as a fallback for important, non-standard announcements, or potentially a general 'Investor Presentation' (IP) if it were a presentation, but here it is a press release about regulatory progress. Given the context of regulatory interaction and clinical trial updates, RNS is the most appropriate general regulatory announcement category when a more specific one isn't available. The document length (6666 chars) is substantial enough that it is the report itself, not just an announcement of a report (RPA).
2021-12-01 French
Abivax receives FDA feedback with guidance on advancing ABX464 into phase 3 clinical testing in ulcerative colitis
Legal Proceedings Report Classification · 1% confidence The document is a press release dated December 1, 2021, announcing that Abivax received feedback from the FDA regarding advancing its drug candidate ABX464 into Phase 3 clinical testing for ulcerative colitis. It details regulatory milestones, future plans (EMA advice, IND update, patient enrollment), and includes standard corporate boilerplate and contact information. This type of announcement, focusing on clinical trial progress and regulatory interactions, is typically classified as a general corporate/regulatory announcement, often falling under the 'Regulatory Filings' (RNS) category if it doesn't fit a more specific financial report type. It is not a formal financial report (10-K, IR, ER, MRQ), nor is it a management discussion (MDA) or an investor presentation (IP). Since it is a news release about clinical/regulatory progress, RNS is the most appropriate general regulatory announcement category.
2021-12-01 English
Les résultats de l'étude de phase 1/2 d'ABX196 menée par Abivax dans le cancer du foie montrent une bonne tolérance et des signaux prometteurs de bénéfice clinique ...
Earnings Release Classification · 1% confidence The document is a press release dated November 30, 2021, announcing positive Phase 1/2 clinical trial results for the drug ABX196 in treating liver cancer (HCC). It details the findings (good tolerance, promising clinical benefit signals) and notes that the abstract was selected for presentation at the ASCO GI Cancers Symposium 2022. The text explicitly states that the detailed content of the abstract will be made public after the ASCO embargo lifts on January 18, 2022. This structure—announcing key results and referencing an upcoming presentation/publication of the full data—is characteristic of an Earnings Release (ER) or a general press release announcing significant operational/clinical updates. Since it focuses on the initial announcement of period results (clinical trial data), 'ER' (Earnings Release) is the most appropriate fit among the options, as it covers the initial release of key performance indicators/results, even if they are clinical rather than purely financial earnings. It is not a full Annual Report (10-K), an Interim Report (IR), or a mere Report Publication Announcement (RPA) because it contains substantial narrative and data summary, not just a notice that a report is attached. FY 2022
2021-11-30 French
Abivax's phase 1/2 clinical study results of ABX196 in liver cancer show good tolerability and promising signals of clinical benefit and were selected for presentation at the ASCO GI Cancers Symposium
Earnings Release Classification · 1% confidence The document is a press release dated November 30, 2021, announcing positive preliminary results from a Phase 1/2 clinical study (ABX196 in liver cancer) and noting that these results were selected for presentation at the ASCO GI Cancers Symposium in January 2022. It contains key highlights, quotes from the investigator, and details about the study and the drug candidate. This format—an initial announcement of key findings and upcoming presentation details—is characteristic of an Earnings Release (ER) or a general corporate/regulatory announcement. Since it is not a full financial report (10-K, IR) or a transcript (CT), and it specifically details clinical trial results which are often released alongside or instead of quarterly earnings for biotech firms, 'ER' (Earnings Release) is the most appropriate fit for summarizing key operational/clinical performance news. It is not a formal regulatory filing like a 10-K or a specific notice like DIV or DIRS. Given the content focuses on clinical progress and upcoming presentation, ER is the best fit among the provided options for a major corporate update. Q4 2021
2021-11-30 English
ABIVAX: Nombre d'actions composant le capital social et nombre total de droits de vote au 31.10.21.
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 of the Commercial Code and Article 223-16 of the AMF General Regulation) and provides a table detailing the number of shares and voting rights as of a specific date (31/10/2021). This type of mandatory disclosure regarding the total number of shares and voting rights is a specific regulatory filing requirement in France, often related to capital structure changes or mandatory periodic updates. While it touches upon capital structure, it is primarily a notification of the current voting power base. This fits best under 'Share Issue/Capital Change' (SHA) if it reflects a change, or more generally as a mandatory regulatory disclosure. Given the specific nature of reporting total voting rights based on AMF rules, it is a specific capital/share structure notification. Since 'SHA' covers share issues/capital changes, and this is a mandatory report on the current share count and voting rights, SHA is the most appropriate fit among the provided options, as it directly relates to the composition of the share capital. It is not a general earnings release (ER) or a full annual report (10-K).
2021-11-19 French
ABIVAX: Nombre d'actions composant le capital social et nombre total de droits de vote au 30.09.21
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 (AMF)'. It presents a table detailing the number of shares and total voting rights as of a specific date (30/09/2021). This type of mandatory disclosure regarding capital structure and voting rights, often published monthly or quarterly in France, does not fit neatly into the primary financial reports (10-K, IR) or specific event announcements (DIV, CAP). It is a regulatory disclosure concerning share capital and voting power. Given the options, this specific disclosure about voting rights and share count is most closely related to notifications about share structure changes or regulatory updates. Since there isn't a specific code for 'Voting Rights Disclosure', and it is a formal regulatory filing concerning share capital, it aligns best with either 'Share Issue/Capital Change' (SHA) or 'Regulatory Filings' (RNS). However, the content is purely about the count of shares and votes, which is a specific type of capital structure update, but not a new issue or buyback. In many contexts, these periodic voting rights disclosures are treated as general regulatory updates. Given the highly specific nature of the other codes, and the fact that this is a mandatory disclosure under AMF rules regarding share capital, 'SHA' (Share Issue/Capital Change) is a plausible fit as it relates directly to the capital base, although it's a reporting of the existing state. A stronger fit, considering the context of mandatory regulatory reporting that isn't a core financial statement, is 'RNS' (Regulatory Filings) as a general catch-all for specific regulatory compliance documents not covered elsewhere. However, since the document is short (2614 chars) and is a direct disclosure of share/vote count, it is a specific regulatory filing. Let's re-evaluate the options. It is not a dividend (DIV), not a major shareholding notification (MRQ - which is about *changes* in ownership thresholds by external parties), and not a transaction in own shares (POS). It is a report on the *total* capital structure. This type of periodic disclosure is often categorized under general regulatory filings or sometimes under capital structure updates. Given the French context and the specific articles cited (L. 233-8 II), this is a mandatory disclosure. I will classify it as 'RNS' (Regulatory Filings) as it is a specific, non-standard regulatory compliance document.
2021-10-21 French

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