Welcome to our dedicated page for Hansa Medical AB news (Ticker: HNSBF), a resource for investors and traders seeking the latest updates and insights on Hansa Medical AB stock.
The HNSBF news page on Stock Titan tracks announcements and developments related to HANSA MEDICAL AB ORD and its underlying company, Hansa Biopharma AB. Hansa Biopharma is a commercial-stage biopharmaceutical company based in Lund, Sweden, focused on rare immunological conditions through an IgG-cleaving enzyme technology platform. News for HNSBF therefore reflects clinical, regulatory, commercial and corporate milestones reported by Hansa Biopharma.
Investors following HNSBF can expect updates on imlifidase, Hansa Biopharma’s first-in-class IgG antibody-cleaving enzyme therapy, and its use in transplantation, autoimmune diseases and gene therapy. Recent communications have included pivotal Phase 3 data from the ConfIdeS trial in highly sensitized kidney transplant patients, Phase 2 results in antibody-mediated rejection after kidney transplantation, and progress in autoimmune indications such as anti-GBM disease and Guillain-Barré Syndrome.
The news flow also covers regulatory and market access decisions for IDEFIRIX (the European trade name for imlifidase) in the desensitization of highly sensitized adult kidney transplant patients, including recommendations and reimbursement decisions by national health authorities and early access programs. Commercial updates, such as regional partnerships and sales performance for IDEFIRIX in Europe, are part of this coverage.
Beyond clinical and commercial topics, the HNSBF news feed features information on collaborations in gene therapy where imlifidase is evaluated as a pre-treatment for AAV-based therapies, as well as financing transactions and corporate governance developments. For investors and observers interested in Hansa Biopharma’s progress, this page provides a centralized view of key press releases and company statements linked to the HNSBF symbol.
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 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 (NASDAQ: HNSA) announced it will present data on its antibody-cleaving enzyme imlifidase at the 2024 American Transplant Congress (ATC). Imlifidase targets IgG and inhibits the IgG-mediated immune response, aiding highly sensitized kidney transplant patients. Key presentations include the reestablishment of COVID-specific IgG antibodies and long-term clinical outcomes of imlifidase. Hansa has conditional European approval for imlifidase under the name IDEFIRIX® and plans to submit a Biologic License Application to the US FDA in 2025. The enzyme is also being studied for pre-treating gene therapy in rare diseases and certain autoimmune conditions.
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Hansa Biopharma (HNSBF) announced a favorable reimbursement decision in Spain, enhancing access to its product Idefirix® across major European markets. Total Q1 revenue reached SEK 24.2m, with SEK 14.3m from product sales, a decline from SEK 30.3m in Q1 2022. The company completed enrollment in a phase 2 study of imlifidase for Guillain-Barré Syndrome (GBS) and initiated a phase 1 study of HNSA-5487. Additionally, the pivotal ConfIdeS trial for kidney transplantation is progressing, with 62 out of 64 patients enrolled. The company reported substantial net losses, SEK 205.4m, from operations and cash consumption of SEK 207.0m.
Hansa Biopharma's Idefirix® has been recommended by the Scottish Medicines Consortium (SMC) for desensitizing highly sensitized kidney transplant patients. This marks a significant milestone, as it is now the first and only product endorsed for this purpose in Scotland. The SMC emphasizes Idefirix® as clinically and cost-effective, allowing NHS Scotland to fund its use in hospitals. This recommendation follows a positive NICE endorsement in England, expanding patient access across the UK.
Hansa Biopharma announced a $70 million non-dilutive financing agreement with NovaQuest Capital Management, aimed at enhancing its development capabilities for imlifidase in kidney transplantation and other therapeutic areas. This funding extends the company's cash runway through 2024, allowing it to support the ConfIdeS trial and advance a global Phase 3 trial for anti-GBM antibody disease. The financing terms include royalty payments on future sales and milestone payments capped at $140 million.
Hansa Biopharma's Nomination Committee has proposed Peter Nicklin as the new Chairman of the Board, replacing Ulf Wiinberg who has chosen not to stand for re-election. Nicklin brings extensive experience in the life sciences and leadership of global teams. Wiinberg, who served since 2016, credited his decision to resign to his commitments in the United States. The Annual General Meeting is scheduled for June 30, 2022, where this proposal will be presented.
Hansa Biopharma has received early access approval for Idefirix® (imlifidase) by France's HAS, enabling immediate treatment for highly sensitized kidney transplant patients. The drug targets HLA antibodies to facilitate transplants and is now available at kidney centers across France for one year. Hansa is actively progressing commercial launch efforts in Europe, with completed pricing and reimbursement in Sweden and the Netherlands. Approximately 3,600 kidney transplants are performed annually in France, with 11.1% involving hyperimmune patients awaiting suitable donors.
Hansa Biopharma announced significant advancements in its business update, revealing progress in European commercialization of Idefirix® and a partnership with Medison for expanding access in Central Eastern Europe and Israel. The first patients have enrolled in the pivotal U.S. ConfIdeS study, evaluating imlifidase as a pre-treatment for kidney transplants. As of December 31, 2021, the company reported a cash position of SEK 889 million. Total revenue for 2021 was about SEK 34 million while total operational loss amounted to approximately SEK 547 million.
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