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 (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.
Hansa Biopharma has announced its attendance at the 43rd Annual J.P. Morgan Healthcare Conference, following significant achievements across three therapeutic areas in the past 12 months. In Autoimmune, the company reported positive data from the Phase 2 trial in Guillain Barre Syndrome and completed enrollment for the Phase 3 anti-GBM trial. Their second-generation IgG cleaving molecule, HNSA-5487, showed promising 12-month analysis results.
In Gene Therapy, Hansa initiated two significant trials: a Phase 1b trial in Duchenne Muscular Dystrophy with Sarepta Therapeutics and a Phase 2 trial in Crigler-Najjar Syndrome with Genethon. The Transplantation segment saw completion of ConfIdeS trial randomization and record-breaking IDEFIRIX quarterly sales of 69.5 MSEK in Q3 2024.
Key 2025 milestones include data readouts from multiple trials and a planned BLA submission to the FDA in the second half of the year. The company continues to develop novel immunomodulating therapies based on its proprietary IgG cleaving platform.
Hansa Biopharma announced positive full results from its Phase 2 study of imlifidase in Guillain-Barré Syndrome (GBS). The study showed that severe GBS patients treated with imlifidase plus IVIg achieved faster recovery, with a median time of 16 days to walk independently. The treatment demonstrated significant advantages compared to standard IVIg therapy alone, with patients walking independently 6 weeks sooner than the control group.
Key findings include: 37% of patients could walk independently within the first week, 67% by eight weeks, and 63% could run or had no functional disability after six months. The comparative analysis showed patients were 6.4 times more likely to walk independently at week 1 and 4.2 times more likely at week 4 compared to the control group.
Hansa Biopharma has completed patient enrollment in the GOOD-IDES-02 trial, a global pivotal Phase 3 trial testing imlifidase for anti-glomerular basement membrane (anti-GBM) disease. The trial enrolled 50 patients across 40+ centers in the US, UK, and EU, ahead of the original 2025 schedule. The study randomized 25 patients to receive imlifidase plus standard of care (SoC) and 25 to receive SoC alone.
The trial aims to evaluate kidney function improvement through estimated glomerular filtration rate (eGFR) and dialysis needs at 6 months. Anti-GBM is a rare autoimmune condition affecting 1.6 people per million annually, with most patients losing kidney function. Imlifidase has received orphan drug designation from both FDA and EMA. Results are expected in 2025.
Hansa Biopharma and Genethon have initiated GNT-018-IDES, a Phase 2 trial evaluating imlifidase as pre-treatment to gene therapy GNT-0003 in patients with Crigler-Najjar syndrome who have pre-existing antibodies against AAV vectors. The trial aims to enable gene therapy treatment for patients previously excluded due to anti-AAV antibodies, which affect up to 1 in 3 potential recipients. The study will include three patients aged ≥18 years requiring phototherapy, with data expected in 2025. GNT-0003 is currently in a pivotal trial and has received EMA PRIME status, potentially becoming the first gene therapy for Crigler-Najjar syndrome.
Hansa Biopharma (HNSA) and Genethon announced the initiation of GNT-018-IDES, a Phase 2 trial combining imlifidase with gene therapy GNT-0003 for Crigler-Najjar syndrome patients with pre-existing anti-AAV antibodies. The trial will evaluate a single intravenous administration of GNT-0003 following imlifidase pre-treatment in three adult patients requiring phototherapy. This collaboration aims to address a significant challenge, as anti-AAV antibodies prevent up to 1 in 3 people from accessing gene therapies. Data from the trial is expected in 2025. GNT-0003 is currently in a pivotal trial and has received EMA PRIME priority status.
Hansa Biopharma (Nasdaq Stockholm: HNSA) announced its participation in the Truist Securities BioPharma Symposium on November 7 in New York. Chief R&D Officer Hitto Kaufmann will join a panel discussion on 'Inflammatory Insights: Advancing Novel Therapeutics Across Autoimmune and Inflammatory Indications' from 10:30 to 11:20 AM EST.
The company recently completed a 12-month follow-up analysis of the NICE-01 trial for HNSA-5487, their next-generation molecule. Results show the drug effectively reduces IgG levels rapidly, offers redosing potential, and maintains a favorable safety profile. Hansa, a pioneer in immunological treatments, has developed a first-in-class IgG antibody-cleaving enzyme therapy for kidney transplantation in highly sensitized patients.
Hansa Biopharma announced positive results from a 12-month follow-up analysis of the NICE-01 trial for HNSA-5487, their next-generation IgG-cleaving molecule. Key findings include:
1. Rapid and robust IgG reduction by over 95% within hours of treatment
2. IgG levels returned to normal range after 6 months
3. Lower pre-treatment anti-drug antibody (ADA) levels and reduced ADA responses compared to imlifidase
4. Clear redosing potential and favorable safety profile
The company plans to focus HNSA-5487's clinical development on chronic autoimmune diseases such as MOGAD, NMO, and MG. These conditions have high unmet medical needs and are caused by misguided IgG antibodies. HNSA-5487's ability to quickly reduce IgG levels could potentially address various symptoms associated with these diseases.
Hansa Biopharma AB (Nasdaq Stockholm: HNSA) has announced the departure of Matthew Shaulis, Chief Commercial Officer and US President, effective late September 2024. The Commercial Leadership team will now report directly to Søren Tulstrup, President and CEO, while a search for a new CCO and US President is underway.
Shaulis expressed pride in the company's progress and its commitment to developing transformative products for patients with rare immunological diseases. Tulstrup acknowledged Shaulis's significant contributions, including commercialization efforts in Europe, acceleration of the ConfIdeS US pivotal study, and initiation of US launch planning.
