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Hansa Biopharma — Investor Relations & Filings

Ticker · HNSA ISIN · SE0002148817 LEI · 549300LLEO25ZJJ3NT91 ST Manufacturing
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Filings indexed 501 across all filing types
Latest filing 2019-03-26 Regulatory Filings
Country SE Sweden
Listing ST HNSA

About Hansa Biopharma

https://www.hansabiopharma.com/

Hansa Biopharma is a commercial-stage biopharmaceutical company that develops and commercializes treatments for rare immunologic diseases. The company's core focus is its proprietary antibody-cleaving enzyme technology platform, designed to target and inactivate immunoglobulin G (IgG) antibodies. This approach aims to inhibit harmful IgG-mediated immune responses. Its lead product, imilfidase, is used to enable kidney transplantation in highly sensitized patients who have a low probability of finding a compatible donor. The company is also advancing its enzyme technology to address unmet medical needs in other therapeutic areas, including acute autoimmune diseases, gene therapy, and oncology, where IgG antibodies can be a barrier to treatment or a driver of the disease.

Recent filings

Filing Released Lang Actions
Hansa Biopharma Receives Ethics and Regulatory Clearance to Start Phase 2 Study of imlifidase in Acute Antibody Mediated Rejection in Kidney Transplantation
Regulatory Filings Classification · 95% confidence The document is a press release dated March 26, 2019, announcing that Hansa Biopharma received ethics and regulatory clearance to start a Phase 2 clinical study for imlifidase. It details the study design, patient population, and provides background information on the condition (AMR) and the drug. The concluding statement, "This is information that Hansa Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation," strongly indicates a mandatory regulatory disclosure. Since it is an announcement of clinical progress and regulatory milestones, and not a full financial report (10-K, IR), an earnings release (ER), or a formal proxy/voting document, it fits best under the general category for significant regulatory announcements that don't fit elsewhere, which is Regulatory Filings (RNS). It is not a Call Transcript (CT), Investor Presentation (IP), or Management Discussion (MDA).
2019-03-26 English
Hansa Biopharma har fått godkänt att starta fas 2 studie med imlifidase i akut antikroppsmedierad avstötning i samband med njurtransplantation
Regulatory Filings Classification · 95% confidence The document is a press release dated March 26, 2019, announcing that Hansa Biopharma has received approval to start a Phase 2 clinical trial for its drug imlifidase in treating acute antibody-mediated rejection (AMR) after kidney transplantation. It details the study design, the medical need, and mentions ongoing regulatory applications (MAA to EMA, BLA discussions with FDA). This type of announcement, focusing on clinical trial progress and regulatory milestones, is characteristic of an Investor Presentation (IP) or a general press release about corporate development. Since it is a detailed announcement about a specific development (clinical trial approval) rather than just a summary of financial results (ER) or a general regulatory filing fallback (RNS), and it contains substantial information often found in investor materials, Investor Presentation (IP) is the most fitting category, although it is structured as a press release. Given the options, it is a communication aimed at investors regarding operational/clinical progress, which aligns closely with the scope of an Investor Presentation (IP) or a detailed corporate update, rather than a standard Earnings Release (ER) or a generic Regulatory Filing (RNS). It is not a full report (10-K, IR) nor a management discussion (MDA). I will classify it as an Investor Presentation (IP) due to the detailed clinical and regulatory update provided.
2019-03-26 Swedish
Hansa Biopharma Announces Selection of NiceR Lead Candidate
Regulatory Filings Classification · 95% confidence The document is a press release dated March 21, 2019, announcing that Hansa Biopharma has selected a lead candidate from its NiceR program for clinical development. It discusses drug development, pipeline progress, and future study plans. This type of announcement, detailing specific scientific or clinical progress outside of routine financial reporting (like earnings or annual reports), is best classified as a general corporate update or announcement. Since it is not a formal regulatory filing like a 10-K, an earnings release (ER), or a specific capital/financing event (CAP), it falls under the general category for corporate news that doesn't fit elsewhere, which is Regulatory Filings (RNS), as it is an announcement made pursuant to the EU Market Abuse Regulation, but the content is focused on R&D progress rather than a mandatory disclosure like insider trading or dividend changes. Given the options, RNS serves as the best fit for a significant, non-financial, non-meeting-related corporate announcement.
2019-03-21 English
Hansa Biopharma tillkännager val av ny läkemedelskandidat ur utvecklingsprogrammet NiceR
Regulatory Filings Classification · 99% confidence The document is a press release from Hansa Biopharma dated March 21, 2019, announcing the selection of a new drug candidate from their NiceR development program. It details scientific progress, management commentary, and concludes with a statement that the information is required to be made public under EU market abuse regulation, followed by contact information. This type of announcement, focusing on a specific corporate development (drug pipeline progress) rather than routine financial results (ER/IR) or mandatory annual filings (10-K), fits best under a general regulatory announcement or news release category. Since it is a specific, material corporate update that isn't explicitly covered by other codes like DIV, CAP, or MANG, and it is not a full report, the most appropriate classification is Regulatory Filings (RNS) as a general regulatory announcement, or potentially Investor Presentation (IP) if it were a slide deck, but it reads like a news release. Given the context of corporate news releases that don't fit specific financial reporting codes, RNS is the best fit for this type of material announcement.
2019-03-21 Swedish
Europeiska läkemedelsmyndigheten har accepterat Hansa Biopharmas ansökan om marknadsgodkännande för IDEFIRIX™ (imlifidase)
Regulatory Filings Classification · 95% confidence The document is a press release dated March 1, 2019, announcing that the European Medicines Agency (EMA) has accepted Hansa Biopharma's Marketing Authorization Application (MAA) for IDEFIRIX™. This announcement details regulatory progress (EMA acceptance, PRIME status, expected CHMP review timeline) and provides context on the drug and the medical need. It is not the full Annual Report (10-K), an Interim Report (IR), or a formal Audit Report (AR). It is a specific announcement regarding a regulatory submission milestone for a drug product. This type of announcement, detailing regulatory steps and progress toward approval, is best classified as a general Regulatory Filing (RNS) or potentially an Investor Presentation (IP) if it were a slide deck, but given the format and content focusing on regulatory milestones and company news, RNS is the most appropriate general regulatory category, as it is a formal communication to the market about regulatory status, distinct from a specific financial report or management discussion.
2019-03-01 Swedish
Hansa Biopharma Announces European Medicines Agency Accepts Marketing Authorization Application for IDEFIRIX™ (imlifidase)
Regulatory Filings Classification · 95% confidence The document is a press release dated March 1, 2019, announcing that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for IDEFIRIX™. This is a specific corporate update regarding regulatory progress for a drug candidate. It is not a full Annual Report (10-K), an Interim Report (IR), or a general Earnings Release (ER). It is a specific announcement about regulatory progress and milestones. While it relates to clinical data, its primary focus is the regulatory submission acceptance. This type of announcement, detailing a specific regulatory event (MAA acceptance) and providing context on the drug development path, fits best under the general category of Regulatory Filings (RNS) as it is a formal announcement to the market about regulatory status, or potentially a general Investor Relations communication. Given the options, RNS serves as the best fit for a broad regulatory announcement that isn't a specific financial report or a management change. However, since it is a formal announcement of a significant corporate event (regulatory milestone) intended for the public/investors, and it is not a specific financial report, RNS is the most appropriate fallback, although it is highly specific content. It is not a CTA, DVA, or MANG. It is a formal announcement, but not a Report Publication Announcement (RPA) because it is the news itself, not an announcement *about* the publication of a separate report. Therefore, RNS is the most suitable classification for this type of regulatory news release.
2019-03-01 English

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