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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 2020-07-09 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
Informacje w zakresie wstępnych założeń dla powtórnego wniosku o dopuszczenie do obrotu leku MabionCD20 - Content (EN)
Regulatory Filings Classification · 100% confidence The document is a 'Current Report' (as indicated by 'Legal basis Article 17(1) MAR - confidential information' and the reference to previous 'Current Reports'). It discusses strategic updates, regulatory filings (MAA to EMA), clinical trial plans (bridging study), and associated costs for a product named MabionCD20. This type of ongoing, material, non-financial operational update, often related to regulatory pathways or strategic direction, fits best under the general category of regulatory or corporate information that isn't a standard financial report (10-K, IR, ER). Since it details legal/regulatory strategy and future plans concerning product registration, it is most closely related to Legal Proceedings/Regulatory Updates. However, given the options, it is a specific update on regulatory strategy and future filings, which is not explicitly covered by LTR (Legal Proceedings Report) or RNS (General Regulatory Filings). Since it details the process and assumptions for a future regulatory submission (MAA), and it is not a standard financial report, it falls under the broad 'Regulatory Filings' category (RNS) as a specific, material, non-financial disclosure, or potentially LTR if the regulatory process is viewed as a legal/regulatory matter. Given the focus on the *application* process and strategy rather than litigation, RNS is the most appropriate fallback for a material, non-standard disclosure. The document length (4290 chars) is substantial enough that it is the report itself, not just an announcement of a report.
2020-07-09 English
Informacje w zakresie wstępnych założeń dla powtórnego wniosku o dopuszczenie do obrotu leku MabionCD20 - Content (PL)
Regulatory Filings Classification · 100% confidence The document is a formal announcement by Mabion S.A. (Spółka) referencing previous reports and detailing strategic updates regarding the regulatory pathway (MAA application to EMA) for a product (MabionCD20). It discusses validation batches, stability testing, plans for a bridging clinical trial (Phase I/II), estimated costs (75-85 million PLN), and a timeline (completion before or early 2022). It concludes by announcing a webinar on July 10, 2020, to discuss the status and plans. This content—a detailed update on regulatory strategy, clinical plans, and financial implications related to product development and registration—is characteristic of a comprehensive management discussion or an update on significant operational/regulatory progress, which aligns best with the 'Management Reports' (MDA) category, as it explains business trends and outlook related to a key project. It is not a simple earnings release (ER), a full annual report (10-K), or just a notice of a dividend (DIV). The announcement of a webinar suggests it might accompany a presentation, but the core text is the detailed management commentary itself.
2020-07-09 Polish
Otrzymanie z Europejskiej Agencji Leków pisemnej odpowiedzi w ramach „Scientific Advice” dotyczącej założeń nowego procesu rejestracyjnego leku MabionCD20 - Content (EN)
Regulatory Filings Classification · 100% confidence The document is a formal announcement regarding the receipt of a written response from the European Medicines Agency (EMA) concerning the regulatory strategy for a product (MabionCD20). It cites 'Legal basis Article 17 para. 1 MAR - confidential information,' indicating a mandatory regulatory disclosure, likely related to material non-public information. The content discusses regulatory consultation ('Scientific Advice') and future plans (webinar announcement). This type of specific, material, non-financial regulatory update that doesn't fit into standard financial reports (10-K, IR, ER) or specific corporate actions (DIV, CAP, M&A) is best classified as a general Regulatory Filing (RNS). It is not a transcript (CT), an earnings release (ER), or a management discussion (MDA). Given its nature as a specific regulatory update concerning legal/regulatory matters, RNS is the most appropriate fallback.
2020-07-01 English
Otrzymanie z Europejskiej Agencji Leków pisemnej odpowiedzi w ramach „Scientific Advice” dotyczącej założeń nowego procesu rejestracyjnego leku MabionCD20 - Content (PL)
Regulatory Filings Classification · 95% confidence The document is a formal announcement (Raport bieżący) from Mabion S.A. regarding receiving written feedback ('Scientific Advice') from the European Medicines Agency (EMA) concerning the regulatory strategy for a product (MabionCD20). It discusses regulatory steps, data requirements, and future plans, including an upcoming webinar to discuss the status. This content relates to regulatory processes, legal/scientific advice concerning product approval, and future communication plans. It is not a full financial report (10-K, IR), an earnings release (ER), or a management discussion (MDA). Since it details specific regulatory interactions and future plans based on that interaction, it fits best under general Regulatory Filings (RNS) as a specific regulatory update that doesn't map perfectly to the other specialized categories like LTR (Legal Proceedings) or DIV (Dividend). Given the context of receiving official advice from a regulatory body (EMA) regarding product registration, RNS is the most appropriate fallback for this specific regulatory update.
2020-07-01 Polish
Podsumowanie subskrypcji akcji zwykłych na okaziciela serii S Spółki przeprowadzonej w ramach realizacji Programu Motywacyjnego za rok 2019 - Content (EN)
Capital/Financing Update Classification · 98% confidence The document is a 'Current Report No. 27/2020' detailing the 'Summary of the subscription of S series ordinary bearershares of the Company carried out under the Incentive Scheme for 2019'. It explicitly discusses the issuance of new shares (500 shares for PLN 50 total value) resulting from the exercise of subscription warrants as part of a conditional share capital increase. This activity directly relates to changes in the company's capital structure and the issuance of new securities. This aligns best with the 'Capital/Financing Update' category (CAP), as it details the completion of a share issuance event related to a financing/incentive scheme, rather than a general regulatory filing (RNS) or a transaction in own shares (POS, which usually implies buybacks or treasury stock transactions).
2020-06-30 English
Podsumowanie subskrypcji akcji zwykłych na okaziciela serii S Spółki przeprowadzonej w ramach realizacji Programu Motywacyjnego za rok 2019 - Content (PL)
Share Issue/Capital Change Classification · 99% confidence The document details the completion of a subscription for new shares (Series S) exercised via warrants issued under a 2019 Incentive Program. It explicitly reports on the subscription process, including dates, number of shares subscribed (500), subscription price (0.10 PLN), total value (50 PLN), and the number of participants (6 individuals). This content directly relates to changes in the company's capital structure resulting from the issuance of new securities, which aligns with the definition of a Capital/Financing Update (CAP). Although it involves shares, it is not a general share issue announcement (SHA) but a specific report on the execution of a pre-approved financing/incentive plan resulting in new capital.
2020-06-30 Polish

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