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BioArctic — Investor Relations & Filings

Ticker · BIOA ISIN · SE0010323311 LEI · 549300Y0OI2WVUNHLC33 ST Professional, scientific and technical activities
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Filings indexed 432 across all filing types
Latest filing 2023-01-11 Regulatory Filings
Country SE Sweden
Listing ST BIOA

About BioArctic

https://www.bioarctic.se/en/

BioArctic is a research-intensive biopharmaceutical company focused on developing disease-modifying treatments, biomarkers, and diagnostics for neurodegenerative diseases. The company's core strategy is based on its proprietary antibody technology, which develops unique treatments that target the misfolded and aggregated proteins considered to be the underlying cause of disorders such as Alzheimer's and Parkinson's disease. Through strategic partnerships with global pharmaceutical companies, BioArctic advances its innovative therapies from research through clinical development and commercialization, aiming to address significant unmet medical needs in neurology.

Recent filings

Filing Released Lang Actions
BioArctics partner Eisai lämnar in ansökan om marknadsgodkännande av lecanemab för behandling av tidig Alzheimers sjukdom i EU
Regulatory Filings Classification · 1% confidence The document is titled "Pressmeddelande" (Press Release) and announces that BioArctic's partner, Eisai, has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for lecanemab. It details the basis for the application (Phase 3 Clarity AD study results), mentions regulatory milestones (EMA validation, FDA approval in the US), and includes standard press release closing statements regarding regulatory disclosure obligations and contact information. This is a corporate announcement regarding a regulatory submission and clinical trial results, but it is not the comprehensive Annual Report (10-K), Interim Report (IR), or the formal Audit Report (AR). Since it is a formal announcement of a significant corporate/regulatory event (submission of a major drug application), and it is structured as a press release, it fits best under the general category for regulatory announcements that aren't specifically financial reports or management changes. Given the options, 'Regulatory Filings' (RNS) is the most appropriate fallback for a general regulatory announcement that doesn't fit a more specific category like ER, DIV, or MANG. However, because the core content is a major regulatory step (submission for market approval), and it is presented as a press release, it is often classified as a general regulatory filing or announcement.
2023-01-11 Swedish
BioArctic’s partner Eisai submits marketing authorization application for lecanemab as treatment for early Alzheimer’s disease in the EU
Regulatory Filings Classification · 1% confidence The document is explicitly labeled as a "Press release" and announces that BioArctic's partner, Eisai, has submitted a marketing authorization application (MAA) for lecanemab to the European Medicines Agency (EMA). It also mentions regulatory filings with the FDA and NMPA, and references milestone payments tied to regulatory submissions. This content is a corporate announcement regarding regulatory progress and clinical trial results, rather than the full regulatory report itself (like a 10-K or IR). Since it is a press release detailing significant corporate and regulatory news, it fits best under the general category for regulatory announcements or press releases that don't fit a more specific financial disclosure type. Given the options, 'Regulatory Filings' (RNS) is the most appropriate fallback for a general regulatory announcement press release that isn't a specific financial report or management change notice. However, because it is a press release announcing a major regulatory step (MAA submission), it is a form of regulatory communication. If 'Press Release' were an option, it would be ideal. Among the provided codes, RNS (Regulatory Filings) serves as the best general category for such announcements that are not core financial statements or specific corporate actions like dividends or director changes.
2023-01-11 English
BioArctic’s partner Eisai submits supplemental Biologics License Application to FDA for traditional approval of LEQEMBI™ (lecanemab-irmb) for the treatment of Alzheimer’s disease
Regulatory Filings Classification · 1% confidence The document is explicitly labeled as a "Press release" announcing that BioArctic's partner, Eisai, has submitted a supplemental Biologics License Application (sBLA) to the FDA for the traditional approval of LEQEMBI, following an accelerated approval. It details clinical trial data (Clarity AD), safety information (ARIA), and regulatory steps. This content is a high-level announcement of a significant regulatory/development milestone, rather than a comprehensive annual report (10-K), a quarterly report (IR), or a formal regulatory filing itself. Since it is a press release detailing a major regulatory submission and clinical outcome, it most closely aligns with an Earnings Release (ER) which often includes major operational/regulatory news, or potentially a Regulatory Filing (RNS) if it were a general announcement. However, given the focus on the submission of a BLA/sBLA and the inclusion of detailed safety/indication information typical of a major drug update, it functions as a significant corporate announcement. Since there is no specific code for 'Regulatory Submission Announcement' outside of the general 'RNS', and it is not a formal financial report, 'RNS' (Regulatory Filings - general regulatory announcements) is the most appropriate fallback, although 'ER' (Earnings Release) often covers such material news if released near a reporting period. Given the date (Jan 7, 2023) is outside typical Q4 earnings release windows, and the content is purely regulatory/clinical progress, RNS is the best fit as a general regulatory announcement.
2023-01-07 English
BioArctics partner Eisai lämnar in kompletterande registreringsansökan till FDA för fullt godkännande av LEQEMBI™ (lecanemab-irmb) för behandling av Alzheimers sjukdom
Regulatory Filings Classification · 1% confidence The document is a press release ("Pressmeddelande") from BioArctic AB, dated January 7, 2023. The core content announces that their partner, Eisai, has submitted a supplementary Biologics License Application (sBLA) to the FDA to convert the accelerated approval of LEQEMBI to a traditional (full) approval for Alzheimer's disease. This is an announcement regarding regulatory submission and progress for a drug. It is not the full Annual Report (10-K), an Earnings Release (ER), or a Call Transcript (CT). Since it details a specific regulatory action (submission of an sBLA) related to a drug approval process, it falls under the category of general regulatory announcements or corporate news that doesn't fit the highly specific financial report codes. Given the options, 'Regulatory Filings' (RNS) is the most appropriate general category for significant, non-financial regulatory updates, although 'LTR' (Legal Proceedings Report) is sometimes used for drug approvals, RNS is a better fit for general regulatory progress announcements that aren't legal disputes. However, since the document is a formal press release announcing a major regulatory step (sBLA submission), and it is not a specific financial report, it is best classified as a general Regulatory Filing (RNS) or potentially a Capital/Financing Update (CAP) if the focus was on the commercialization aspect, but the focus here is clearly regulatory submission. Given the context of drug approval milestones, RNS is the best fit as a general regulatory announcement.
2023-01-07 Swedish
FDA godkänner Leqembi™ (lecanemab-irmb) via det accelererade förfarandet för behandling av Alzheimers sjukdom
Earnings Release Classification · 1% confidence The document is titled "Pressmeddelande" (Press Release) in Swedish and announces that the FDA has granted accelerated approval for Leqembi (lecanemab-irmb) for the treatment of Alzheimer's disease. It details the indication, dosing, side effects, and future plans, including pricing and reimbursement discussions. The concluding paragraph explicitly states: "Denna pressmeddelande är en förkortad version av den engelska originalet... som publicerats samtidigt som detta pressmeddelande." This structure—a formal announcement of a significant regulatory event (FDA approval) and associated business updates—is characteristic of an Earnings Release (ER) or a general Regulatory Filing (RNS). Since this is a major, time-sensitive announcement regarding a regulatory milestone and includes financial implications (milestone payment, pricing), it fits best as an Earnings Release (ER) which often encompasses key operational and regulatory news, or potentially a Regulatory Filing (RNS) if it were less comprehensive. Given the depth of the announcement regarding the approval, the drug details, and the mention of a separate press release regarding pricing, ER is a strong candidate, but the explicit nature of it being a regulatory announcement that doesn't fit the strict definition of 10-K, IR, or CT makes RNS (Regulatory Filings/General Announcement) a very safe and appropriate classification, especially since it is a press release announcing a regulatory event. However, in many databases, major regulatory approvals announced via press release are often categorized under ER if they contain financial/operational impact, or RNS if they are purely informational. Given the context of a major drug approval announcement, which often accompanies or precedes quarterly reporting cycles, and the fact that it is a formal announcement of a significant event, I will classify it as an Earnings Release (ER) as it contains key operational and financial news related to the product's success, even if it's not strictly quarterly results. If ER is too specific, RNS is the fallback. Since it announces a major milestone and financial entitlement, ER is slightly more descriptive than the general RNS. FY 2023
2023-01-06 Swedish
FDA approves LEQEMBI™ (lecanemab-irmb) under the Accelerated Approval pathway for the treatment of Alzheimer’s disease
Regulatory Filings Classification · 1% confidence The document is explicitly titled as a "Press release" announcing that the FDA has approved LEQEMBI™ (lecanemab-irmb) under the Accelerated Approval pathway for Alzheimer's disease. It details the indication, dosage, adverse reactions, and safety information, which are typical components of an initial regulatory approval announcement or a major clinical/regulatory milestone announcement. Since it is a press release announcing a major regulatory event (FDA approval) and not a comprehensive periodic financial report (like 10-K or IR), it best fits the category for general regulatory announcements or news releases that don't fit other specific financial reporting codes. Given the options, 'Regulatory Filings' (RNS) is the most appropriate fallback for a significant, non-periodic regulatory news announcement, although 'Earnings Release' (ER) is sometimes used for major news, this is specifically regulatory/product news. However, since it is a press release announcing a major regulatory event (FDA approval) and not a standard financial report, and it doesn't fit the definitions for ER (which is usually quarterly results), AR (which is a standalone audit), or CT (transcript), RNS (Regulatory Filings/General Announcement) is the best fit as a catch-all for significant, non-standard regulatory news.
2023-01-06 English

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