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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 2020-03-17 Capital/Financing Update
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
Ustalenia w zakresie finansowania działalności Spółki w świetle nowej strategii regulacyjnej MabionCD20 w EMA - Content (PL)
Capital/Financing Update Classification · 98% confidence The document text, written in Polish, discusses the Board of Directors receiving supporting documents from major shareholders (founders) who have declared their intention to recapitalize the company with no less than PLN 15 million in 2020. It explicitly mentions that the recapitalization can occur through the subscription of new shares or the use of debt instruments. The Board accepted these documents and decided to initiate actions aimed at securing debt financing to support the new strategy for registering the MabionCD20 drug. This content directly relates to fundraising, financing activities, and capital structure changes (new shares or debt). Therefore, the most appropriate classification is Capital/Financing Update (CAP).
2020-03-17 Polish
Zmiana strategii regulacyjnej leku MabionCD20 w EMA - Content (PL)
Regulatory Filings Classification · 95% confidence The document is a formal communication from Mabion S.A. (Spółka) to the market, referencing previous reports and detailing a strategic change regarding the regulatory pathway for their drug, MabionCD20, with the European Medicines Agency (EMA). It discusses regulatory strategy modification, withdrawal of previous applications, and plans for a new, large-scale application. This type of announcement, concerning regulatory strategy, legal/procedural updates related to product approval, and significant operational decisions, fits best under 'Legal Proceedings Report' (LTR) if it relates to regulatory actions or 'Regulatory Filings' (RNS) as a general announcement. Given the focus on regulatory procedure changes and consultation with the EMA, it is a significant regulatory update. Since there is no specific category for 'Regulatory Strategy Change,' and it is not a standard financial report (10-K, IR, ER), nor a management change (MANG) or dividend notice (DIV), it falls under the general regulatory announcement category, RNS, or potentially LTR if viewed as a procedural challenge. However, RNS is the designated fallback for general regulatory announcements that don't fit elsewhere. The document length (2687 chars) is short, but it is the primary content, not an announcement *of* an attached report, so RPA is not appropriate. I will classify it as RNS as it is a material, non-financial regulatory update.
2020-03-17 Polish
Dirk Kreder _życiorys
Board/Management Information Classification · 99% confidence The document text provides detailed biographical information, education, qualifications, and previous roles for a newly appointed President (Prezes Zarządu) of MABION S.A., named Dirk Kreder. This content directly relates to changes in senior management personnel. According to the definitions, announcements of changes in the company's board of directors or senior management fall under the 'Board/Management Information' category, which corresponds to the code MANG.
2020-03-16 Polish
Rezygnacja Członka Rady Nadzorczej Spółki i powołanie Prezesa Zarządu Spółki - Content (PL)
Board/Management Information Classification · 99% confidence The document text announces a change in senior management: Mr. Dirk Kreder resigned from the Supervisory Board and was immediately appointed as the President of the Management Board (CEO) of Mabion S.A. It also includes his CV and declarations regarding external activities and solvency. This directly corresponds to the definition of Board/Management Information.
2020-03-16 Polish
Aktualizacja informacji na temat procedury rejestracyjnej dotyczącej dopuszczenia przez Europejską Agencję Leków leku MabionCD20 do obrotu - Content (PL)
Regulatory Filings Classification · 92% confidence The document text is very short (759 characters) and discusses an update regarding the application process for a drug (MabionCD20) with the European Medicines Agency (EMA), specifically mentioning participation in a committee meeting (CHMP) for an 'oral explanation'. This is a specific, material event update related to regulatory/legal proceedings concerning a product. It is not a full financial report (10-K, IR), an earnings release (ER), or a general announcement of a report (RPA). It fits best under 'Legal Proceedings Report' (LTR) as it details interactions with a regulatory body regarding product approval, which often involves legal/procedural steps, or potentially 'Regulatory Filings' (RNS) as a general update. Given the context of interaction with a regulatory body concerning a product application, LTR is a strong fit, but RNS is the general fallback for specific regulatory updates that aren't explicitly covered elsewhere. Since this is a specific procedural update regarding a product application/review, and not a lawsuit, RNS (Regulatory Filings) serves as the most appropriate general category for non-standard regulatory communications.
2020-02-26 Polish
Otrzymanie podsumowania spotkania BPD Typu 3 z Agencją ds. Żywności i Leków (FDA) w sprawie rejestracji oraz dopuszczenia do obrotu leku MabionCD20 na terytorium USA - Content (PL)
Regulatory Filings Classification · 95% confidence The document text is a short announcement (981 characters) in Polish referencing a previous report (raport bieżący nr 4/2020) regarding a meeting with the US FDA concerning a Biosimilar Biological Product Development (MabionCD20). It states that the Management Board received a summary from the FDA and will now analyze the document and its guidelines. Because this is a brief update announcing the receipt of regulatory feedback/guidance rather than the full regulatory document itself, and it doesn't fit specific categories like Director's Dealing, Dividend, or Earnings Release, it falls best under the general 'Regulatory Filings' category (RNS) as a miscellaneous regulatory update, or potentially a Legal Proceedings Report (LTR) if the context implied a formal legal action, but RNS is safer for general regulatory correspondence updates. Given the context of receiving feedback from a regulatory body (FDA) on a product registration strategy, RNS (Regulatory Filings) is the most appropriate fallback for this specific type of regulatory correspondence update.
2020-02-14 Polish

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