CareersPipelineCollaboration RareInnovation SVGOMG The best SVG optimizer and minifier Open SVG Paste markup Demo Contribute SVGOMG provides you several options to clean and compress your SVG files. Clean up, remove, merge, minify. Upload or copy the source of your SVG to get started! 947 bytes → 267 bytes 28.19% Finance peopleAdvance treatment Skip to main contentSkip to navigationSkip to search
HNSA   ( ,  %) SEK
Quotes are delayed 15 minutes

Hansa Biopharma invite to Capital Markets Day 2026 in New York

12 Jun 2026, 07:00

Lund, Sweden, June 12, 2026. Hansa Biopharma AB, “Hansa” (Nasdaq Stockholm: HNSA), is pleased to welcome investors and analysts to a Capital Markets Day on June 25, 2026. The Capital Markets Day will be held at The St. Regis Hotel, Two East 55th Street, at Fifth Avenue, New York, and will be broadcast live online. The event will begin at 9:00 AM EDT (3:00 PM CEST) and is expected to last until 12:00 EDT. Lunch will be available directly after the program ends.

Capital Markets Day will highlight kidney transplantation in highly sensitized patients and feature insights from leading medical experts Matthew Cooper, MD (Medical College of Wisconsin); Nassim Kamar, MD, PhD (Toulouse University Hospital, France); Roslyn Mannon, MD (University of Nebraska Medical Center); and Annette Jackson, PhD, F(ACHI) (Duke University Medical Center).

The program will include a review of the results from the pivotal U.S. Phase 3 ConfIdeS study presented at ATC on June 22, 2026, as well as findings from the European Post‑Authorisation Efficacy Study (PAES) with Idefirix/imlifidase in Europe. Dialogues with medical experts will focus on the medical need in the context of existing alternatives today for highly sensitized patients, as well as experiences from the Phase 3 study. Company presentations will address the strategy, the market opportunity and Hansa Biopharma’s pre-launch and commercialization preparations ahead of a potential U.S. approval.

A live question and answer session will follow the formal presentations.

Registration of interest to participate in the Capital Markets Day is via the following link. You are required to register in advance for the event.

--- ENDS ---

Contacts for more information:

Kerstin Falck, VP Global Corporate Affairs
[email protected]  

[email protected]

Notes to editors

About highly sensitized patients

Highly sensitized patients have pre-formed antibodies called donor specific antibodies (DSAs) with a broad reactivity against human leukocyte antigens (HLAs), which can cause tissue damage and potentially transplant rejection.1 The presence of DSAs means that highly sensitized patients tend to have limited or no access to transplant, as finding a compatible donor organ can be particularly challenging.2,3 The complexity of their immunological profile means that highly sensitized patients spend longer time than average on transplant waiting lists, with evidence showing that this longer time waiting for a suitable donor relates to an increased mortality risk.4,5 Across the U.S. and Europe, highly sensitized patients comprise around 10-15% of the total of patients on transplant waiting lists.6,7

About imlifidase

Imlifidase is conditionally approved in the European Union, Norway, Liechtenstein, Iceland and the UK under the tradename Idefirix® for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor. Idefirix® is also approved in Australia, Israel and Switzerland.

Information about the trial is available at ClinicalTrials.gov: NCT04935177

About Idefirix® (imlifidase)

Imlifidase is an antibody-cleaving enzyme originating from Streptococcus pyogenes that specifically targets and cleaves immunoglobulin G (IgG) antibodies and inhibits IgG-mediated immune response.8 It has a rapid onset of action, cleaving IgG-antibodies and inhibiting their activity within hours after administration.

Imlifidase has conditional marketing approval in Europe and is marketed under the trade name Idefirix for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor. The use of Idefirix should be reserved for patients who are unlikely to be transplanted under the available kidney allocation system, including prioritization programs for highly sensitized patients.8 Idefirix was reviewed as part of the European Medicines Agency’s (EMA) PRIority Medicines (PRIME) program, which supports medicines that may offer a major therapeutic advantage over existing treatments or benefit patients without treatment options.8

The efficacy and safety of imlifidase as a pre-transplant treatment to reduce donor-specific IgG antibodies was studied in four phase 2 single-arm studies in EU and US as well as a randomized, controlled Phase 3 study in US.5,7,10-11.

In the US, the Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) for imlifidase in February of 2026 and assigned a Prescription Drug User Fee Act (PDUFA) action date of December 19, 2026.

Full product information can be accessed via the initial Summary of Product Characteristics found here.

About kidney failure

Kidney disease can progress to kidney failure or End-Stage Renal Disease (ESRD), identified when a patient’s kidney function is less than 15%.12 ESRD poses a significant health burden, affecting nearly 2.5 million patients worldwide.12 A kidney transplant is the treatment of choice for suitable patients with ESRD because it offers improved survival and quality of life benefits, and is cost savings compared to long-term dialysis. There are approximately 170,000 kidney patients in the U.S. and Europe waiting for a new kidney.13

About Hansa Biopharma

Hansa Biopharma AB is a pioneering commercial-stage biopharmaceutical company developing and commercializing novel immunomodulatory therapies to transform care for patients with acute or complex immune disorders. Hansa’s proprietary IgG-cleaving enzyme technology platform addresses serious unmet medical needs in transplantation, gene therapy and autoimmune diseases. The company’s portfolio includes imlifidase, a first-in-class immunoglobulin G (IgG) antibody-cleaving enzyme therapy, which has been shown to enable kidney transplantation in highly sensitized patients, and HNSA-5487, a next-generation IgG-cleaving molecule that will be developed for Guillain-Barré Syndrome (GBS). Hansa Biopharma is based in Lund, Sweden, and has operations in Europe and the U.S. The company is listed on Nasdaq Stockholm under the ticker HNSA. Find out more at  www.hansabiopharma.com  and follow us on LinkedIn.

©2026 Hansa Biopharma AB. Hansa Biopharma, the beacon logo, IDEFIRIX, and IDEFIRIX flower logo are trademarks of Hansa Biopharma AB, Lund, Sweden. All rights reserved.

References

  1. Eurostam Report (A Europe-wide strategy to enhance transplantation of highly sensitized patients on the basis of acceptable HLA mismatches.) Available at https://cordis.europa.eu/project/id/305385/reportin
  2. Redfield RR, et al. The mode of sensitization and its influence on allograft outcomes in highly sensitized kidney transplant recipients. Nephrol Dial Transplant.2016 Oct;31(10):1746-53. doi: 10.1093/ndt/gfw099.
  3. Lonze BE, et al. IdeS (Imlifidase): A Novel Agent That Cleaves Human IgG and Permits Successful Kidney Transplantation Across High-strength Donor-specific Antibody. Ann Surg. 2018 Sep;268(3):488-496. doi: 10.1097/
  4. Alelign T, Ahmed MM, Bobosha K, Tadesse Y, Howe R, Petros B. Kidney Transplantation: The Challenge of Human Leukocyte Antigen and Its Therapeutic Strategies. J Immunol Res. 2018 Mar 5;2018:5986740. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5859822/
  5. Heidt S, et al. Highly Sensitized Patients are Well Serves by Recieving a Compatible Organ Offer Based on Acceptable Mismatches. Front Immunol. 2021;12:687254. Available at: https://pubmed.ncbi.nlm.nih.gov/34248971/
  6. Organ Procurement and Transplantation Network (OPTN) and Scientific Registry of Transplant Recipients (SRTR). OPTN/SRTR 2022 Annual Data Report. U.S. Department of Health and Human Services, Health Resources and Services Administration; 2024. Accessed [June 2024].
  7. Jordan SC, et al. Imlifidase Desensitization in Crossmatch-positive, Highly Sensitized Kidney Transplant Recipients: Results of an International Phase 2 Trial (Highdes). Transplantation. 2021 Aug 1;105(8):1808-1817. doi: 10.1097/TP.0000000000003496.
  8. European Medicines Agency. Idefirix® summary of product characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/idefirix-epar-product-information_en.pdf.
  9. Jordan SC, et al. IgG Endopeptidase in Highly Sensitized Patients Undergoing Transplantation. N Engl J Med  2017;377:442-453. DOI: 10.1056/NEJMoa16125
  10. Winstedt L, et al. Complete Removal of Extracellular IgG Antibodies in a Randomized Dose-Escalation Phase I Study with the Bacterial Enzyme IdeS--A Novel Therapeutic Opportunity. PLoS One. 2015 Jul 15;10(7):e0132011. doi: 10.1371/journal.pone.0132011. PMID: 26177518; PMCID: PMC4503742.
  11. Lorant T, et al. Safety, immunogenicity, pharmacokinetics, and efficacy of degradation of anti-HLA antibodies by IdeS (imlifidase) in chronic kidney disease patients. Am J Transplant. 2018 Nov;18(11):2752-2762. doi: 10.1111/ajt.14733.
  12. NIH (2018). What is kidney failure? Available at: https://www.niddk.nih.gov/health-information/kidney-disease/kidney-failure/what-is-kidney-failure.
  13. Newsletter Transplant 2022. International figures on donation and transplantation. Available at: Newsletter Transplant - latest edition I Freepub (edgm.eu) Accessed: May 2024

Files