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Mabion S.A. — Investor Relations & Filings

Ticker · MAB ISIN · PLMBION00016 LEI · 259400KG5JVQPPZL6X53 WAR Manufacturing
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Filings indexed 1,002 across all filing types
Latest filing 2020-01-13 Regulatory Filings
Country PL Poland
Listing WAR MAB

About Mabion S.A.

https://www.mabion.eu/en/

Mabion S.A. is an integrated Contract Development and Manufacturing Organization (CDMO) that provides end-to-end services for the development and manufacturing of protein-based biotherapeutics. The company specializes in monoclonal antibodies and biosimilars, offering a complete workflow from cell line development and banking to process optimization and large-scale GMP manufacturing. Core competencies include upstream processing using mammalian cell cultures, downstream purification involving chromatography and viral clearance, and technology transfer for scale-up. Mabion partners with pharmaceutical and biotechnology companies to support both clinical and commercial supply, streamlining the path from gene to final drug product.

Recent filings

Filing Released Lang Actions
Aktualizacja informacji w zakresie procedury rejestracyjnej leku MabionCD20 - Content (PL)
Regulatory Filings Classification · 95% confidence The document text is a short communication (1440 characters) from Mabion S.A. referencing previous reports and providing an update on the regulatory process for a drug application with the European Medicines Agency (EMA). It discusses planned submission of answers to questions, potential meeting dates (CHMP), and outlines various possible outcomes (positive/negative decision, further questions, oral responses). Crucially, the last sentence states: "O złożeniu odpowiedzi do EMA Spółka poinformuje odrębnym raportem bieżącym" (The Company will inform about the submission of the response to the EMA in a separate current report). This structure—providing a brief update on a regulatory/legal process and promising a future report on the outcome—is characteristic of an ongoing regulatory or legal matter update, but because it is a brief update about the status of an application/procedure rather than a formal legal filing or a definitive outcome, it fits best under the general 'Regulatory Filings' category (RNS) as a miscellaneous regulatory announcement, or potentially 'Legal Proceedings Report' (LTR) if the application process is viewed as a regulatory hurdle. Given the context is an update on an EMA application status, RNS (Regulatory Filings) is the most appropriate general category for this type of ongoing procedural communication that isn't a full report or a specific legal action update.
2020-01-13 Polish
Terminy przekazywania raportów okresowych w roku obrotowym 2020 - Content (PL)
Report Publication Announcement Classification · 99% confidence The document text, written in Polish, explicitly states that the Management Board of Mabion S.A. is announcing to the public the schedule (dates) for submitting periodic reports (annual, quarterly, semi-annual) for the year 2020, based on a specific regulation (§ 80 ust. 1 Rozporządzenia Ministra Finansów). This document is not the report itself (like 10-K or IR), but an announcement detailing *when* those reports will be released. This perfectly matches the definition of 'Report Publication Announcement' (RPA), which covers announcements regarding the timing or release of company reports.
2020-01-10 Polish
Otrzymanie podsumowania z posiedzenia CHMP w zakresie procedury rejestracyjnej leku MabionCD20 - Content (PL)
Legal Proceedings Report Classification · 99% confidence The document is a 'raport bieżący' (current report) from Mabion S.A. informing the public about receiving a summary of issues from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) regarding the marketing authorization application for a drug (MabionCD20). This communication details regulatory feedback, required responses, and the impact (or lack thereof) on internal timelines. This content relates directly to regulatory processes, legal/regulatory interactions, and updates on product approval status, which falls under the scope of significant regulatory or legal matters. Since it is an update on a regulatory procedure (drug approval) and not a full financial report (10-K, IR) or a general announcement of a report's release (RPA), the most fitting category is Legal Proceedings Report (LTR) as it concerns significant regulatory action/feedback, or potentially Regulatory Filings (RNS) as a catch-all for specific regulatory updates. Given the focus on specific feedback from a regulator (EMA/CHMP) concerning a product application, LTR is a strong candidate, but RNS is often used for non-financial, specific regulatory updates that aren't lawsuits. However, since the core subject is the interaction with a regulator regarding a product application status, and it is not a standard financial filing, I will classify it as a Regulatory Filing (RNS) as it is a specific, non-standard regulatory update that doesn't fit the other specific categories like DIRS, DIV, or CAP. The document is short and is an announcement of receiving regulatory feedback, not the final outcome or a full legal filing.
2019-12-16 Polish
Aktualizacja informacji na temat procedury rejestracyjnej dotyczącej dopuszczenia do obrotu leku MabionCD20 oraz ujawnienie opóźnionej informacji poufnej - Content (PL)
Legal Proceedings Report Classification · 99% confidence The document discusses the proceedings of the Committee for Medicinal Products for Human Use (CHMP) regarding a marketing authorization application for a drug (MabionCD20). It details the regulatory process, the company's decision to delay disclosure based on MAR regulations (Article 17), and mentions that the company is awaiting the final outcome and will report details later. Crucially, it announces an upcoming teleconference to discuss the situation. This content relates to significant legal/regulatory developments concerning the company's product pipeline and regulatory standing, which falls under 'Legal Proceedings Report' (LTR) if it were a lawsuit, but here it is a specific regulatory update concerning product approval status and related internal/external communications. Since it is a detailed update on a significant regulatory/legal matter (drug approval process) that is not a standard financial report (10-K, IR, ER), and it involves specific regulatory bodies (EMA/CHMP), it best fits the category for significant legal/regulatory updates. Given the context of regulatory proceedings and potential market impact, LTR (Legal Proceedings Report) is the closest fit for significant non-financial regulatory events, although 'RNS' (Regulatory Filings) is a strong fallback. However, the core subject is the status of a regulatory application and the subsequent communication strategy, which is a significant legal/regulatory event. Given the options, and that it is a detailed report on regulatory proceedings rather than just a general announcement of a report, LTR is chosen over RNS, as it concerns the outcome of a regulatory review process.
2019-12-13 Polish
Uzyskanie zgody NCBiR na wydłużenie terminu realizacji projektu badawczego - Content (PL)
Capital/Financing Update Classification · 95% confidence The document text is a short announcement from the Management Board ('Zarząd') of Mabion S.A. It informs the public about receiving approval from the National Centre for Research and Development ('NCBiR') to extend the deadline for a specific R&D project by 9 months, until September 30, 2020. This is a specific update regarding a funded project, which relates to financing or capital structure changes, or potentially a regulatory/grant update. Given the options, it is not a full financial report (10-K, IR), an earnings release (ER), or a management change (MANG). It is an announcement concerning the status of a significant project grant/financing. Since it details an update on a project funded by a public body (NCBiR), it fits best under Capital/Financing Update (CAP) as it relates to the financial execution and timeline of a major investment, or potentially Regulatory Filings (RNS) if no better fit exists. However, because it directly concerns the timeline and funding execution of a major development project, CAP is the most appropriate specific category over the general RNS fallback. The document is short and is an announcement, not the underlying agreement itself.
2019-12-09 Polish
Tekst jednolity Statutu Spółki
Regulatory Filings Classification · 98% confidence The document text is written in Polish and details the 'STATUT SPÓŁKI' (Articles of Association) of Mabion Spółka Akcyjna. It covers general provisions, the company's business activities (PKD codes), founders, detailed breakdown of the share capital (including various series of shares and voting rights), conditional capital increases related to warrants, and detailed rules regarding the transfer, pre-emption rights, and right of first refusal for shares. This content is foundational corporate governance documentation, not a periodic financial report (like 10-K or IR), an earnings announcement (ER), or a meeting material (AGM-R, DEF 14A). The closest fit among the provided codes for foundational corporate rules and structure is Governance Information (CGR), although Articles of Association are often filed separately or as part of a larger corporate filing. Given the comprehensive nature detailing structure, capital, and shareholder rights, CGR is the most appropriate classification for this statutory document.
2019-12-06 Polish

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