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: HNSA) reported interim January–September 2025 results and clinical progress on Oct 30, 2025. Key clinical milestone: imlifidase met the pivotal U.S. Phase 3 ConfIdeS primary endpoint with 12‑month mean eGFR 51.5 vs 19.3 mL/min/1.73m2 (difference 32.2; p<0.0001) and a safety profile consistent with prior studies. The company plans a BLA submission to FDA before year‑end 2025 under accelerated approval with a Priority Review request. YTD product sales rose to 143.6 MSEK (+25.4% YoY). Cash and short‑term investments were 252.1 MSEK at period end.
Hansa (Nasdaq: HNSA) will host a virtual event on Wednesday 12 November 2025 at 9:00 AM EST / 15:00 CET featuring transplant surgeons Professor Robert Montgomery and Professor Matthew Cooper.
The session includes an introduction by CEO Renée Aguiar-Lucander, presentation of topline results from the US Phase 3 ConfIdeS trial by CMO Richard Philipson, a moderated discussion on clinical practice and the medical need for highly sensitized kidney transplant patients, and a live Q&A.
The event aims to provide clinician perspectives on the clinical relevance of the ConfIdeS topline results and potential implications for standard of care in the US transplant community.
Hansa Biopharma (HNSBF) announced positive topline results from its pivotal US Phase 3 ConfIdeS trial evaluating imlifidase in highly sensitized kidney transplant patients. The trial met its primary endpoint with superior kidney function at 12 months, showing mean eGFR of 51.5 mL/min/1.73m2 in the imlifidase arm versus 19.3 mL/min/1.73m2 in the control arm (p<0.0001).
The trial demonstrated statistically significant dialysis independence at 12 months as a key secondary outcome. Imlifidase was well-tolerated with a safety profile consistent with previous trials. Hansa plans to submit a Biologic License Application (BLA) to the FDA under accelerated approval pathway by the end of 2025.
Hansa Biopharma (Nasdaq Stockholm: HNSA) has announced three key executive appointments to strengthen its leadership team ahead of potential US market expansion. Brian Gorman joins as Chief Legal Officer and Corporate Secretary, bringing over 20 years of global experience, including significant M&A expertise from roles at Sinclair Pharma, Calliditas Therapeutics, and Opiant Pharmaceuticals.
Sandra Frithiof has been appointed as Chief Human Resources Officer, leveraging 25 years of HR experience, notably in supporting US market entry at Calliditas Therapeutics. Additionally, Kerstin Falck Lagercrantz will join as VP Corporate Affairs, bringing extensive experience from Pfizer AB in corporate affairs and commercial operations.
These appointments come at a crucial time as Hansa prepares for two Phase 3 readouts and its first BLA submission while strengthening its US pre-commercial activities.
Hansa Biopharma (NASDAQ:HNSA) reported Q2 2025 financial results, highlighting a 76% year-over-year increase in IDEFIRIX product sales to 47.8 MSEK. The company secured a directed cash share issue of 232 MSEK (US $24.3M) and restructured its NovaQuest debt, with US $14.9M of outstanding debt converted to equity.
First half 2025 IDEFIRIX sales reached 113.5 MSEK, representing a 52% increase over 1H 2024. The company's pipeline progress includes upcoming data readouts from two Phase 3 programs in kidney transplantation and anti-GBM, with a planned BLA submission to FDA in second half 2025. The secured financing extends cash runway into Q2 2026.
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.
