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  • Hansa Biopharma AB
    Scheelevägen 22 22363 Lund, Sweden
    +46 (0) 461 656 70
    http://www.hansabiopharma.com
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    Hansa Biopharma and partner Sarepta Therapeutics plan to initiate a clinical study with imlifidase as a pre-treatment to Sarepta’s SRP-9001 gene therapy in DMD in 2023

    · The clinical study will evaluate  imlifidase as pre-treatment in patients with pre-existing IgG antibodies to Sarepta’s SRP-9001, an investigational AAV-based gene therapy for the treatment of DMD · DMD is an irreversible, progressive disease affecting one in 3,500 to 5,000 males born worldwide[[[1]]][ ] Lund, Sweden November 2, 2022. Hansa Biopharma AB, “Hansa” (Nasdaq Stockholm: HNSA), a pioneer in enzyme technology for rare immunological conditions, today announced that its partner Sarepta Therapeutics plans to initiate a clinical study in 2023 to evaluate imlifidase as pre-

    Bulletin from the Annual General Meeting in Hansa Biopharma AB (publ)

    The following resolutions were passed at the Annual General Meeting of Hansa Biopharma AB (publ) (the “Company”) on 22 May 2019. Resolution regarding the adoption of the income statement and the balance sheet as well as consolidated income statement and consolidated balance sheet, appropriation of result and discharge from liability The Annual General Meeting resolved to adopt the income statement and balance sheet, consolidated income statement and balance sheet for 2018. Furthermore, it was resolved that the Company’s results shall be carried forward and thus no dividend will be

    Hansa Biopharma to Present at the Cowen 39th Annual Health Care Conference

    Lund, Sweden, March 6, 2019 – Hansa Biopharma AB (NASDAQ Stockholm: HNSA), the leader in immunomodulatory enzyme technology for rare IgG-mediated diseases, announced today that Søren Tulstrup, President and CEO of Hansa Biopharma, will present at the Cowen 39th Annual Health Care Conference on Wednesday, March 13, 2019 at 9:20AM ET/ 3:20PM CET. The conference will be held at the Boston Marriott Copley Place in Boston, MA.A live webcast will be available on the Events & Webcast page of the Company's website, www.hansabiopharma.com. A replay of the presentation will be available approximately

    Hansa Biopharma Announces European Medicines Agency Accepts Marketing Authorization Application for IDEFIRIX™ (imlifidase)

    Lund, Sweden, March 1, 2019 – Hansa Biopharma AB (NASDAQ Stockholm: HNSA), the leader in immunomodulatory enzyme technology for rare IgG-mediated diseases, announced today that the European Medicines Agency (EMA) has accepted the Company’s Marketing Authorization Application (MAA) for review of IDEFIRIX™ (INN: imlifidase). Hansa is seeking approval of IDEFIRIX as a treatment to enable kidney transplantation in highly sensitized patients. IDEFIRIX is a novel antibody-degrading enzyme that eliminates immunological barriers. It is administered as a single intravenous infusion immediately prior

    Increase of number of shares and votes in Hansa Biopharma AB (publ)

    Lund, Sweden, February 28, 2019 – Hansa Biopharma AB (NASDAQ Stockholm: HNSA), the leader in immunomodulatory enzyme technology for rare IgG-mediated diseases, announced today that the Company’s number of shares and votes has changed as a result of a new issue of 50,000 ordinary shares carried out in February. The new issue was carried out as part of the completion of the Company’s warrant program 2015-2019. In addition, the Company has converted 3,075 C shares into ordinary shares under Hansa’s long-term incentive programme.As of February 28, 2019, the total number of registered and

    Hansa Biopharma Year-End Report 2018

    With positive clinical results from the Company’s lead clinical program, Hansa readies for transition to commercial-stage companyOctober – December 2018 in brief ›› To better reflect its evolution and long-term aspirations, Hansa Medical AB changed its name to Hansa Biopharma AB. The new name represents the next stage in the Company’s lifecycle and emphasizes Hansa’s focus on the development and commercialization of biopharmaceuticals. This refinement of Hansa’s profile is particularly salient as the Company continues the international expansion of its business and investor base. ›› In

    Hansa Medical to Host Conference Call to Provide Year-End Report 2018 Business Update

    Lund, Sweden, January 31, 2019 – Hansa Medical AB (publ) (Nasdaq Stockholm: HNSA) (“Hansa Medical” or the “Company”), under name change to Hansa Biopharma AB, a biopharmaceutical company focused on inhibition of immunoglobulin G (IgG)-mediated immunopathologies, today announced that Hansa Medical will publish the 2018 Year-End Report on 8 February 2010, at 08:00AM CET, and that all interested parties are invited to participate in a telephone conference, which will include a presentation, on the same day at 2:00PM CET. The event will be hosted by Hansa Medical’s CEO and President, Søren

    Increase of number of votes in Hansa Medical AB (publ)

    Lund, Sweden, January 31, 2019 – Hansa Medical AB (publ) (Nasdaq Stockholm: HNSA) (“Hansa Medical” or the “Company”), under name change to Hansa Biopharma AB, a biopharmaceutical company focused on inhibition of immunoglobulin G (IgG)-mediated immunopathologies, today announced that the Company’s number of votes has changed as a result of the conversion of 13,142 C shares into ordinary shares during January under Hansa Medical’s long-term incentive program.As of January 31, 2019, the total number of registered and outstanding shares of Hansa Medical totals 40,681,654 of which 39,973,032 are

    Hansa Medical Announces Appointment of Anne Säfström Lanner as Vice President, Global Human Resources

    Lund, Sweden, January 18, 2019 -- Hansa Medical AB (NASDAQ Stockholm: HNSA), the leading biopharma company focusing on inhibition of immunoglobulin G (IgG)-mediated immunopathologies, today announced the appointment of Anne Säfström Lanner as Vice President, Global Human Resources.Mrs. Lanner has over 15 years of broad human resources experience in international growth companies, including developing and implementing strategies for talent acquisition and management, organizational culture and employer branding, compensation and benefits, and employee training and development. Prior to

    Hansa Medical AB Provides Regulatory Update for Imlifidase in Kidney Transplantation

    Lund, Sweden, January 15, 2019 - Hansa Medical AB (Nasdaq Stockholm:HNSA) (“Hansa Medical” or the “Company”), a biopharmaceutical company focused on inhibition of immunoglobulin G (IgG)-mediated immunopathologies, today provided an update following the Company’s regulatory interactions with the European Medical Agency (EMA) and the U.S. Food and Drug Administration (FDA) for imlifidase in kidney transplantation.“We have had very productive meetings with the EMA and FDA, during which both agencies provided positive feedback on the data generated on imlifidase to date and acknowledged the

    Hansa Medical AB to change name to Hansa Biopharma AB

    Lund, Sweden, December 20, 2018-Hansa Medical AB (publ) (Nasdaq Stockholm:HMED) (“Hansa Medical” or the “Company”), the leading biopharma company focusing on inhibition of immunoglobulin G (IgG)-mediated immunopathologies, today announced that the name change resolutions approved at an Extraordinary General Meeting ("EGM") held on December 4, 2018, have been approved by the ‘Bolagsverket’ in Sweden.The name change will be implemented in the next days and weeks and the Company stock ticker symbol has changed from “HMED” to “HNSA”.  The information was submitted for publication, through

    Bulletin from the Extraordinary General Meeting of Hansa Medical AB (publ)

    Lund, Sweden, 11 December 2018 - Hansa Medical AB (PR Newswire) (Nasdaq Stockholm: HMED) (“Hansa Medical” or the “Company”), today held an extraordinary general meeting. The extraordinary general meeting resolved to change Hansa Medical’s company name to Hansa Biopharma AB, in accordance with the board of directors’ proposal.“The new name Hansa Biopharma emphasizes our focus on the development and commercialization of biological drugs, biopharmaceuticals. This refinement of our profile is particularly important for the continued internationalization of our business and our investor base.”

    Hansa Medical AB Announces Increase in Number of Shares and Votes

    Lund, Sweden, November 30, 2018 - Hansa Medical AB (PR Newswire) (Nasdaq Stockholm:HMED) (“Hansa Medical” or the “Company”), a biopharmaceutical company focused on inhibition of immunoglobulin G (IgG)-mediated immunopathologies, today announced that the Company’s registered share capital, number of outstanding shares and votes have increased during the month of November 2018.As previously announced, the board of directors of Hansa Medical resolved on a share issue of 1,776,765 ordinary shares, on November 13, 2018, by virtue of authorization by the extraordinary general meeting held on

    Hansa Medical Interim report July – September 2018

    July – September 2018 in brief ›› Hansa successfully completed two Phase 2 clinical studies evaluating imlifidase for kidney transplantation in highly sensitized patients, with imlifidase enabling transplantation in all 35 patients. ›› Imlifidase met all primary and secondary endpoints in each study. ›› Treatment with imlifidase enabled highly sensitized patients to receive life-saving transplants. ›› Hansa plans to submit Biologics License Application (BLA) and Marketing Authorization Application (MAA) filings by Q1 2019, with their potential acceptance of submission within 60

    Increase of Number of Shares and Votes in Hansa Medical AB (publ)

    Lund, Sweden, October 31, 2018 - Hansa Medical AB (NASDAQ Stockholm:HMED), the leading biopharma company focusing on inhibition of immunoglobulin G (IgG)-mediated immunopathologies, today announced that the Company’s registered share capital and number of outstanding shares and votes have increased during the month of October 2018.As previously announced on September 6, 2018. Hansa’s board of directors resolved to issue 391,503 class C shares, by virtue of authorization by the general meeting held on May 29, 2018. Furthermore, the Hansa general meeting resolved to adopt a warrant program

    Bulletin from the Extraordinary General Meeting of Hansa Medical AB

    On October 29, 2018, Hansa Medical AB (NASDAQ Stockholm: HMED) held an extraordinary general meeting. The following resolution was passed at the general meeting.Approval of the board’s proposal to authorize the board to resolve on new issues of ordinary shares The general meeting resolved to authorize the board, for the period up to the next annual general meeting, to adopt decisions, whether on one or several occasions and whether with or without pre-emptive rights for the shareholders, to issue new common shares, provided that such issues, in aggregate, must not exceed ten percent of

    Presentation at ASN Kidney Week 2018 Highlights Stable Renal Function at up to 24 Months Following Transplantation Enabled by Imlifidase

    Lund, Sweden, October 26, 2018- Hansa Medical AB (NASDAQ Stockholm:HMED), the leading biopharma company focusing on inhibition of immunoglobulin G (IgG)-mediated immunopathologies, today announced that data on imlifidase (previously known as IdeS), the Company’s IgG cleaving enzyme, was highlighted in a presentation at the American Society of Nephrology (ASN) Kidney Week 2018, being held October 23-28, 2018 in San Diego, USA.The presentation, titled IdeS in Highly Sensitized Patients, was presented at ASN Kidney Week 2018 by Stanley C. Jordan, M.D., Director of Kidney Transplantation and

    Hansa Medical's Nomination Committee for the AGM 2019 Appointed and 2019 Financial Calendar Published

    Lund, Sweden, October 25, 2018 - Hansa Medical AB (Nasdaq Stockholm: HMED), the leading biopharma company focusing on inhibition of immunoglobulin G (IgG)-mediated immunopathologies, today announced the appointment of the Nomination Committee for the Annual General Meeting (AGM) 2019 and the publication of the 2019 financial calendar.In accordance with the decision of the AGM on May 29, 2018, a Nomination Committee for the Hansa Medical AGM 2019 has been formed. Based on the list of shareholders as of 31 August 2018, the three largest shareholders have been contacted and invited to each

    Hansa Medical to Report Interim Results for the Third Quarter of 2018 and Host Conference Call and Webcast

    Lund, Sweden, October 25, 2018 - Hansa Medical AB (Nasdaq Stockholm:HMED), the leading biopharma company focusing on inhibition of immunoglobulin G (IgG)-mediated immunopathologies, will publish the Company’s interim report for the period from July 1 to September 30, 2018 on November 1, 2018, at 8:00 AM CET (3:00 AM ET). The publication of the interim report will be followed by a conference call and webcast presentation at 2:00 PM CET (9:00 AM ET) the same day, and all interested parties are invited to participate in the conference call. The event will be hosted by Hansa Medical’s CEO and

    Hansa Medical Receives Positive Opinion for Orphan Drug Designation in the EU for Imlifidase for Anti-GBM Disease

    Lund, Sweden, October 24, 2018- Hansa Medical AB (NASDAQ Stockholm:HMED), the leading biopharma company focusing on inhibition of immunoglobulin G (IgG)-mediated immunopathologies, today announced that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has issued a positive opinion on Orphan Drug Designation for imlifidase for the treatment of anti-glomerular basement membrane (anti-GBM) antibody disease. A positive opinion by the COMP precedes official designation by the European Commission."This positive opinion on Orphan Drug Designation for

    Hansa Medical Receives FDA Fast Track Designation for Imlifidase for Transplantation

    Lund, Sweden, October 17, 2018- Hansa Medical AB (NASDAQ Stockholm: HMED), the leading biopharma company focusing on inhibition of immunoglobulin G (IgG)-mediated immunopathologies, today announced that the U.S. Food and Drug Administration (FDA) has granted imlifidase Fast Track Designation for the investigation of imlifidase for transplantation.Imlifidase (IdeS) is an enzyme in late-stage clinical development that specifically cleaves IgG antibodies, thereby inhibiting the IgG-mediated immune response. Hansa Medical is initially developing imlifidase as a proprietary treatment to enable

    Notice of Extraordinary General Meeting of Hansa Medical AB (publ)

    The shareholders of Hansa Medical AB (publ) are summoned to attend the Extraordinary General Meeting on 29 October 2018, at 10.00 CET at Hansa Medical’s offices on Scheelevägen 22, Lund, Sweden.  The shareholders of Hansa Medical AB (publ) are hereby summoned to attend the Extraordinary General Meeting (“EGM”) on 29 October 2018, at 10.00 CET at Hansa Medical’s offices on Scheelevägen 22, Lund, Sweden. Registration starts at 09.30 CET and will be possible until the EGM starts.  Right to participateThose who have been recorded as shareholders in the share register kept by Euroclear

    Hansa Medical Reports Positive Final Top Line Results from Two Phase 2 Studies of Imlifidase for Kidney Transplantation

    · Imlifidase meets all primary and secondary endpoints in both studies · Treatment with imlifidase enables highly sensitized patients to receive lifesaving transplants  · Hansa Medical plans to submit BLA and MAA filings in Q4 2018 or Q1 2019 · Company to host conference call today, September 27 2018 at 2pm CEST (5am PDT, 8am EDT, 1pm BST)Lund, Sweden, September 27, 2018- Hansa Medical AB (NASDAQ Stockholm: HMED), the leading biopharma company focusing on inhibition of immunoglobulin G (IgG)-mediated immunopathologies, announced today the successful completion of two Phase 2

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