Hansa Biopharma AB (publ)
Stockholm Stock ExchangeRecent
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- Hansa Biopharma AB (publ) is a commercial-stage biopharmaceutical company that develops and commercializes innovative immunomodulatory enzyme therapies targeting pathogenic IgG antibodies for patients with rare immunological conditions, including transplant desensitization, autoimmune diseases, gene therapy pre-treatment, and oncology applications; its lead product, Idefirix (imlifidase), is a first-generation enzyme administered via single intravenous infusion to rapidly inactivate IgG antibodies, approved in the European Union for desensitization of highly sensitized adult kidney transplant patients with positive crossmatch tests; the company advances a next-generation enzyme, HNSA-5487, enabling potential repeat dosing to extend IgG-free windows, alongside a pipeline of 11 clinical and preclinical programs evaluated across transplantation, rare IgG-mediated autoimmune disorders like anti-GBM disease and Guillain-Barré syndrome, gene therapy for conditions such as Duchenne muscular dystrophy, Limb-girdle muscular dystrophy, Pompe disease, and Crigler-Najjar syndrome, and exploratory oncology indications. Founded in 2007 and headquartered in Lund, Sweden, Hansa Biopharma operates primarily in Europe with expanding presence in the United States and commercialization partnerships in Central Eastern Europe and Israel, serving highly sensitized transplant patients, those with acute immune disorders, and individuals with pre-existing antibodies hindering gene therapies; it maintains strategic alliances including ongoing collaborations with Sarepta Therapeutics (since 2020) for gene therapy pre-treatment in muscular dystrophies, AskBio (since 2022) for Pompe disease, Généthon (since 2023) for Crigler-Najjar syndrome with Phase 2 trial initiation (GNT-018-IDES), and Medison Pharma (since 2021) for regional Idefirix distribution. Recent developments encompass strong Idefirix sales growth of 83% in 2024 with record quarterly revenues exceeding SEK 65 million in Q1 2025 across 18 European countries with secured reimbursement, a SEK 672 million (USD 71 million) directed share issue in September 2025 to fund a planned U.S. Biologics License Application filing for imlifidase in kidney transplantation (requesting FDA priority review), debt restructuring with NovaQuest extending cash runway into Q2 2026, topline Phase 3 data successes in transplant desensitization driving over 25% market cap increase, full enrollment in post-approval studies, and upcoming catalysts such as Phase 3 readout in anti-GBM disease (GOOD-IDES-02), Phase 2 data in Crigler-Najjar, and Phase 2 publication in Guillain-Barré syndrome.
Hansa Biopharma announces closing of €115 million licensing transaction with SERB Pharmaceuticals for Idefirix in Europe and MENA
Hansa Biopharma reports positive efficacy and safety results from Idefirix® European post authorization study in kidney transplantation
Hansa Biopharma reports positive efficacy and safety results from Idefirix® European post authorization study in kidney transplantation
Hansa Biopharma Announces Late-Breaking Abstract from ConfIdeS Phase 3 Trial Selected for Oral Presentation at ATC 2026
Hansa Biopharma enters into €115 million licensing agreement with SERB Pharmaceuticals for IDEFIRIX in Europe and MENA
Hansa Biopharma enters into €115 million licensing agreement with SERB Pharmaceuticals for IDEFIRIX in Europe and MENA
Hansa Biopharma publishes 2025 Annual and Sustainability Reports
Hansa Biopharma publishes 2025 Annual and Sustainability Reports
PDUFA Action Date for Hansa Biopharma's Imlifidase BLA Set for December 19, 2026
PDUFA Action Date for Hansa Biopharma's Imlifidase BLA Set for December 19, 2026
Hansa Biopharma Reports Fourth Quarter and Full-Year 2025 Financial Results
Hansa Biopharma Reports Fourth Quarter and Full-Year 2025 Financial Results
Hansa Biopharma Submits BLA to FDA for Imlifidase in desensitization for Kidney Transplantation
Hansa Biopharma Submits BLA to FDA for Imlifidase in desensitization for Kidney Transplantation