Welcome to our dedicated page for HNSA news (Ticker: HNSA), a resource for investors and traders seeking the latest updates and insights on HNSA stock.
Hansa Biopharma (HNSA) is a leader in developing IgG-cleaving enzyme therapies for complex immunological challenges. This page provides essential updates on clinical advancements, regulatory milestones, and strategic initiatives across transplantation, autoimmune diseases, and gene therapy applications.
Investors and researchers will find comprehensive coverage of HNSA's progress with IDEFIRIX commercialization, next-generation candidates like HNSA-5487, and pivotal trials addressing anti-GBM disease and transplant desensitization. Our curated news collection enables efficient tracking of scientific breakthroughs and market developments.
Key updates include clinical trial results, partnership announcements with gene therapy innovators, financial performance reports, and regulatory submissions. All content is verified through primary sources to ensure accuracy and current relevance.
Bookmark this page for structured access to HNSA's evolving therapeutic pipeline and scientific leadership in antibody-mediated conditions. Regular updates reflect the company's commitment to transforming treatment paradigms through targeted enzyme technology.
Hansa Biopharma (NASDAQ Stockholm: HNSA) has appointed Dr. Richard Philipson as Chief Medical Officer (CMO), effective July 14, 2025. Dr. Philipson brings over 25 years of industry experience and will report to CEO Renée Aguiar-Lucander as a member of the Executive Committee.
Dr. Philipson's extensive background includes serving as CMO at Calliditas Therapeutics, 16 years at GlaxoSmithKline including leadership in the Rare Diseases Unit, and positions at Takeda and Trizell. His track record includes contributing to four product approvals in rare disease and gene therapy, along with expertise in building clinical development programs across all phases.
Hansa Biopharma (Nasdaq Stockholm: HNSA) presented positive five-year follow-up data from the 17-HMedIdeS-14 study of imlifidase in kidney transplantation at the 2025 ESOT Congress in London. The extended pooled analysis demonstrated sustained positive outcomes in highly sensitized patients who received imlifidase-enabled kidney transplants.
Key findings include a 90% patient survival rate at five years (with three deaths occurring between six months and one year) and a death-censored graft survival rate of 82%. The mean estimated glomerular filtration rate (eGFR) at five years was 50 mL/min/m2, indicating favorable kidney function compared to typical post-transplant outcomes where eGFR usually ranges between 40-60 ml/min per 1.73 m2 at three years with continued decline at five years.
The presentation by Dr. Massimo Mangiola from NYU Langone Transplant Institute builds on previously published data in the American Journal of Transplantation, confirming imlifidase as a viable option for HLA-incompatible transplantation with long-term benefits comparable to standard kidney transplants.
Hansa Biopharma (HNSA) will present data from its Phase 2 single-arm study of imlifidase, an IgG cleaving enzyme, for treating Guillain-Barré Syndrome (GBS) at the 2025 PNS Annual Meeting in Edinburgh. The study, conducted across the UK, France, and Netherlands, evaluated a single dose of imlifidase (0.25 mg/kg) combined with standard of care intravenous immunoglobulin (IVIg) in 30 adult GBS patients.
Professor Shahram Attarian from Hopitaux Universitaires de Marseille will present the findings on May 18. The study results, initially communicated in December 2024, showed that administering imlifidase prior to standard of care was safe and well-tolerated, demonstrating significant potential for treating GBS patients.
Hansa Biopharma (Nasdaq Stockholm: HNSA) has appointed Maria Törnsén as Chief Operating Officer (COO) and President U.S., effective May 19, 2025. Törnsén brings over 20 years of experience in global and US operations, most recently serving as President North America at Calliditas Therapeutics until its acquisition by Asahi Kasei Corporation in 2024. Her extensive background includes senior leadership roles at Sarepta Therapeutics, Sanofi Genzyme, and Shire plc, where she successfully launched multiple products and led a $1.6Bn global franchise. Törnsén will report to CEO Renée Aguiar-Lucander and join the Executive Committee, bringing her expertise in rare diseases and gene therapy to support IDEFIRIX growth and prepare for upcoming catalysts in H2 2025.
Hansa Biopharma (HNSA) reported strong Q1 2025 financial results with total revenue of 66.3 MSEK, driven by IDEFIRIX® product sales of 65.7 MSEK, representing a 39% increase from Q1 2024. Key operational highlights include:
- Completed enrollment in Post Authorization Efficacy and Safety study
- Secured access in three additional European markets
- Growing repeat utilization of IDEFIRIX® across Europe
- Appointment of Renée Aguiar-Lucander as new CEO
Financial metrics:
- SG&A expenses: 76.0 MSEK
- R&D expenses: 64.3 MSEK
- Operating loss: 93.4 MSEK
- Net loss: 37.1 MSEK
- Cash position: 250.2 MSEK
Multiple pipeline catalysts expected in H2 2025, including data readouts from U.S. ConfIdeS Phase 3 trial in kidney transplantation and anti-GBM Phase 3 trial.
Hansa Biopharma (NASDAQ Stockholm: HNSA) has published its 2024 Annual and Sustainability Reports, highlighting significant achievements including an 83% year-on-year growth in IDEFIRIX® sales. The company expanded market access to 18 European markets for IDEFIRIX® as a desensitization treatment for kidney transplant patients.
Key 2024 milestones include:
- Completion of randomization in the pivotal Phase 3 ConfIdeS trial, with BLA submission to FDA planned for 2H 2025
- Successful results from NICE-01 trial of HNSA-5487, targeting myasthenia gravis
- Completion of GOOD-IDES-02 Phase 3 trial enrollment in anti-GBM disease
- Positive results from Phase 2 study in Guillain-Barré Syndrome
- Progress in gene therapy collaborations with Genethon and Sarepta
The company maintained its Great Place to Work® certification for the fifth consecutive year with 95% survey participation, while conducting its first Double Materiality Assessment to enhance sustainability practices.
Hansa Biopharma (HNSA) has completed enrollment in its European Phase 3 20-HMedIdeS-19 Post Authorization Efficacy and Safety (PAES) study for IDEFIRIX® (imlifidase), a first-generation desensitization treatment for kidney transplantation.
The study involves 50 highly sensitized kidney transplant patients and 64 patients in a reference cohort across 22 European sites. The PAES study aims to determine one-year graft failure-free survival in patients receiving imlifidase desensitization before HLA-incompatible kidney transplantation.
Data readout is expected in the second half of 2026, after which Hansa will seek full authorization from the European Medicines Agency. This study follows the conditional authorization granted by the European Commission for IDEFIRIX® in 2020.
Hansa Biopharma reported strong financial results for Q4 and full year 2024, with IDEFIRIX product sales showing an 83% increase to 189.7 MSEK compared to the previous year (103.7 MSEK), excluding a 49.6 MSEK provision for retroactive price adjustments. Including the provision, 2024 IDEFIRIX sales reached 140.1 MSEK, a 35% increase year-over-year.
The company achieved significant pipeline milestones, including positive Phase 2 results in Guillain-Barré Syndrome, favorable 12-month analysis from the NICE-01 study of HNSA-5487, and completion of enrollment in the GOOD-IDES-02 Phase 3 study. Total revenue for 2024 was 220.9 MSEK (171.3 MSEK after provision), representing a 28% increase from 2023.
Q4 2024 showed IDEFIRIX product sales of 25.6 MSEK, with quarterly fluctuations due to European kidney allocation systems. The company's operating loss improved to -637.4 MSEK for 2024 compared to -788.5 MSEK in 2023.
