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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 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 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

    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

    Hansa Medical lead candidate imlifidase (IdeS) granted orphan drug designation by the FDA for anti-GBM antibody disease

    Hansa Medical today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to imlifidase (IdeS) for the treatment of anti-GBM antibody disease (anti-GBM), also known as Goodpastures disease. More information about the orphan drug designation has been posted on www.fda.govAnti-GBM is a severe kidney disease where the immune system mistakenly develops IgG-antibodies, resulting in an acute immune attack on the kidneys and in some patients also on the lungs. In severe anti-GBM, the disease may progress to renal failure or death. There is no approved

    Hansa Medical Interim Report January–March 2018

    IdeS (INN: imlifidase) continues to demonstrate its unprecedented ability to enable transplantation for highly sensitized patientsJanuary-March 2018 in brief · Søren Tulstrup appointed new President and CEO of Hansa Medical, effective March 20, 2018. He has broad and extensive experience as senior executive in the global biopharma industry. Hansa Medical’s acting CEO Ulf Wiinberg reverts to his former role as Chairman of Hansa Medical and Birgit Stattin Norinder reverts to her former role as board member. · Completed enrollment in Hansa Medical’s international multicenter Phase II

    Completed enrollment in Hansa Medical’s international multi-center Phase II study Highdes

    Hansa Medical AB (Nasdaq Stockholm: HMED), a biopharmaceutical company focusing on novel immunomodulatory enzymes, announced today the completion of enrollment for the international multi-center study Highdes.The study aimed to recruit 15-20 patients. A total of 18 patients have been treated with the company’s lead candidate IdeS and subsequently transplanted at five clinics in the US and Europe. All treated and transplanted patients will be followed up for six months. The primary objective of the study - to turn a positive cross-match test into a negative and thereby enable kidney

    Finalized enrollment in US Phase II study with IdeS in highly sensitized patients

    Hansa Medical AB (Nasdaq Stockholm: HMED), a biopharmaceutical company focusing on novel immunomodulatory enzymes, announced today that enrollment has been finalized in the US investigator-initiated Phase II study with lead candidate IdeS in highly sensitized patients.A total of 17 patients have been enrolled in the study (ClinicalTrials.gov Identifier: NCT02426684) at Cedars-Sinai Medical Center with Professor Stanley Jordan as principal investigator. The study aimed at enrolling 10 to 20 patients. Patients had donor specific antibodies (DSAs) and a positive cross-match test prior to IdeS

    The New England Journal of Medicine publishes results from Phase II studies of Hansa Medical’s lead candidate IdeS in highly sensitized patients

    Hansa Medical AB (Nasdaq Stockholm: HMED), a biopharmaceutical company developing novel immunomodulatory enzymes, today announced that combined data from three independent clinical Phase II studies with Hansa Medical’s lead candidate IdeS will appear in The New England Journal of Medicine 2017;377:442-53, August 3, 2017 issue.In the article “IgG Endopeptidase in Highly Sensitized Patients Undergoing Transplantation”, researchers demonstrated that treatment with IdeS is effective in reducing donor specific antibodies (DSAs) to levels allowing lifesaving kidney transplantation of highly

    Hansa Medical to present at Jefferies 2017 Global Healthcare Conference

    Hansa Medical will present at the Jefferies 2017 Global Healthcare Conference on June 9 in New York City. Göran Arvidson, Chief Executive Officer, will present at the conference at 1:00 p.m. EDT. (7:00 p.m. CEST).A live audio webcast of the presentation will be accessible through the Hansa Medical website www.hansamedical.com and through the following link: http://wsw.com/webcast/jeff105/hmed  The information was submitted for publication, through the agency of the contact person set out below, at 8 am CEST on June 7, 2017.

    Published preclinical results confirm IdeS potential in cancer immunotherapy

    Hansa Medical AB (publ), a biopharmaceutical company developing novel immunomodulatory enzymes, announced today that preclinical data have been published in the peer-reviewed journal, Molecular Cancer Therapeutics (Järnum et al., Mol Cancer Ther May 22 2017 DOI: 10.1158/1535-7163.MCT-17-0108), confirming the potential of the company’s lead candidate IdeS in cancer immunotherapy.The published findings demonstrate how pre-treatment with IdeS in tumour animal models can increase the efficacy of currently available antibody based cancer therapies. Christian Kjellman, Senior Vice President R&

    Top-line clinical results from US study with lead candidate IdeS to be presented at the American Transplant Congress

    Hansa Medical AB (Nasdaq Stockholm: HMED), a biopharmaceutical company developing novel immunomodulatory enzymes, today announced that top-line clinical results from the ongoing investigator initiated US study will be presented in an oral session at the 2017 American Transplant Congress (ATC) in Chicago, U.S. on 30 April.  The top-line results from the study, demonstrate that treatment with IdeS completely eliminates donor specific antibodies (DSAs) and enables transplantation of HLA incompatible patients. An abstract with the top-line data and conclusions is available through the ATC website

    Hansa Medical to present at The Oppenheimer 27th Annual Healthcare Conference

    Hansa Medical will present at the Oppenheimer 27th Annual Healthcare Conference on March 21 in New York City. Göran Arvidson, Chief Executive Officer, will present at the conference at 8:35 a.m. EST. (2:35 p.m. CET)A live audio webcast of the presentation will be accessible through the Hansa Medical website www.hansamedical.com and through the following link: https://www.veracast.com/webcasts/opco/healthcare2017/33101593658.cfm  This information is information that Hansa Medical AB (publ) is obliged to make public pursuant to the Financial Instruments Trading Act. The information was

    Hansa Medical announces successful completion of a Phase II clinical trial of IdeS in sensitized kidney patients

    Hansa Medical AB (Nasdaq Stockholm: HMED), a biopharmaceutical company focusing on novel immunomodulatory enzymes, announces The second Swedish open label Phase II IdeS-study conducted at Uppsala University Hospital and Karolinska University Hospital in Huddinge is now complete with all IdeS treated patients transplanted.Hansa Medical AB today announced completion of a Phase II study entitled “A Phase II Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of Intravenous Ascending Doses of IdeS in Kidney Transplantation” in which 10 sensitized kidney patients were given

    Hansa Medical’s application for Orphan Drug Designation for IdeS in the EU receives positive opinion

    LUND, Sweden, December 15, 2016, Hansa Medical AB (publ: HMED), a biopharmaceutical company focusing on novel immunomodulatory enzymes, announces that the Committee for Orphan Medicinal Products (COMP) at the European Medicines Agency (EMA) has issued a positive opinion on Hansa Medical’s application for Orphan Drug Designation of recombinant IdeS for the prevention of graft rejection following solid organ transplantation. In September 2015, IdeS was granted Orphan Drug Designation for the prevention of antibody mediated organ rejection in solid organ transplant patients by the U.S. Food and

    Hansa Medical proposes a directed share issue

    · The board of directors of Hansa Medical AB (publ) (“Hansa Medical” or the “Company”) proposes a directed share issue of approximately SEK 185 million. · The subscription price for the issue is proposed to be SEK 70 per share. · The issue is directed to selected international specialist investors including HBM Healthcare Investments, Sectoral Asset Management, Sphera Funds Management and Aescap, as well as Swedish institutional and strategic investors including Carnegie Asset Management,AFA Insurance, KK-stiftelsen, Thomas Olausson and Unionen. · Shareholders representing

    Top line results from the Swedish ongoing Phase II study with IdeS in sensitized patients presented

    Hansa Medical AB (publ) today announced that preliminary results of the Sweden based ongoing Phase II study of IdeS were presented today by Professor Gunnar Tufveson at the 26th International Congress of the Transplantation Society in Hong Kong on August 23, 2016. The results show that IdeS has enabled kidney transplantation in all 10 out of 10 included sensitized patients. The Phase II study also shows that IdeS treatment resulted in negative cross match test in all patients, none of the transplanted patients experienced delayed graft function and all 10 transplantations resulted in very

    Hansa Medical Interim report April – June 2016

    Continued positive development of IdeS in clinical studiesSecond quarter in brief Business highlights›› US Food and Drug Administration (FDA) cleared Hansa Medical’s IND application for a study with IdeS in kidney transplantation ›› All patients are recruited and successfully desensitized in Swedish Phase II study with IdeS in kidney transplantation ›› Successful desensitization with IdeS in all recruited patients in ongoing US Phase II study with kidney transplantation ›› Hansa Medical appointed Henk Doude van Troostwijk as Vice President, Commercial Operations ›› Annual

    Hansa Medical initiates pivotal multicenter study in the US with IdeS for treatment of refractory highly sensitized kidney patients

    Hansa Medical AB (publ) today announced that the company sponsored pivotal multicenter study in the US with IdeS in refractory highly sensitized patients is open for recruitment.The single arm Phase II study will include approximately 20 highly sensitized patients awaiting kidney transplantation, who are refractory to currently available desensitization strategies. The patients in this new study have either failed on previous attempts of desensitization or the currently available methods are considered insufficiently effective. The study is entitled "A Phase II Study to Evaluate the

    Successful desensitization with IdeS in all recruited patients in ongoing US Phase II study

    Hansa Medical AB (publ) today announced that additional data from the ongoing US Phase II study with IdeS in kidney transplantation was presented at the 2016 American Transplant Congress (ATC) in Boston on June 14 at 6:00 pm (EDT).The ongoing Phase II study at Cedars Sinai Medical Center is an investigator-initiated study that is looking at the effects of IdeS in enabling kidney transplantation in highly sensitized kidney transplant patients. Recruitment for the study will be up to 20 patients. The data presented by the study’s principal investigator Professor Stanley Jordan, shows that

    Initial results from the ongoing Swedish Phase II study with IdeS in sensitized kidney transplant patients will be presented at TTS 2016

    Dr. Tomas Lorant, principal investigator, will present data from the ongoing Swedish Phase II study with IdeS in sensitized kidney transplant patients at the 26thInternational Congress of the Transplantation Society in Hong Kong in August 2016. The meeting abstract published ahead of the presentation includes preliminary data from 6 transplanted patients with HLA antibodies in the on-going Phase II study.The ongoing and now fully recruited Phase II study includes 10 patients that received a single dose of IdeS (0.25 or 0.5 mg/kg) before kidney transplantation. The study primarily evaluates

    Ongoing US study shows that IdeS allows for transplantation of highly sensitized patients

    An initial evaluation of the ongoing US study with IdeS at Cedars Sinai Medical Center shows that IdeS completely eliminates donor specific antibodies and allows for kidney transplantation in all sensitized patients. These results are for four patients that were included in the US study as of January 2016. As of today 10 patients have been treated and subsequently transplanted. Initial results from the study will be presented by Professor Stanley Jordan, the study’s principal investigator, at the 2016 American Transplant Congress (ATC) in Boston on June 14 at 6:00 pm.The ongoing Phase II

    FDA clears Hansa Medical’s IND application for IdeS in kidney transplantation

    Hansa Medical AB (publ) today announced that the US Food and Drug Administration (FDA) has completed the safety review of the company’s Investigational New Drug application (IND) and has concluded that the proposed clinical investigation can proceed. This enables Hansa Medical to start a clinical study to primarily evaluate IdeS’ efficacy in making highly sensitized kidney patients with positive crossmatches eligible for transplantation by removing donor specific antibodies. The clinical trial is scheduled to begin soon.The single arm study will include up to 20 kidney transplantation

    Hansa Medical AB (publ) - Year-End Report 2015

    Several significant milestones reached in 2015January – December 2015 in summary – Highlights October – December · Hansa Medical’s shares began trading on Nasdaq Stockholm on November 2, 2015 · Data from the first patient in the ongoing US study with IdeS in highly sensitized patients presented at Hansa Medical’s Capital Markets Day on November 13, 2015, showed that one dose of IdeS effectively inactivates donor specific antibodies · Data published in Journal of Immunology shows that IdeS temporarily can silence B-cells, preventing B-cells from developing into antibody

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