公司资料
Hansa Biopharma AB 股价、新闻与催化剂
- 股票代码:
- HNSA
- 交易所:
- NASDAQ
- 行业:
- Biotechnology
- 所在地:
- United States
股价为何变动
Current closing-price context is not available for HNSA.
公司概览
IgG-Cleaving Immunology Platform
Hansa Biopharma is a commercial-stage biopharmaceutical company developing therapies for rare immunological diseases. Its platform uses IgG-cleaving enzymes to rapidly inactivate disease-causing or treatment-limiting antibodies, with programs spanning transplantation, autoimmune disease, gene therapy, and next-generation enzyme therapeutics. Hansa is headquartered in Lund, Sweden, with operations in Europe and the United States.
Idefirix Transplant Franchise
Idefirix, or imlifidase, is conditionally approved in Europe to desensitize highly sensitized adult kidney-transplant candidates with a positive crossmatch against an available deceased donor. By temporarily removing circulating IgG antibodies, the treatment is designed to enable transplantation for patients who may otherwise remain incompatible with donor organs. Hansa has licensed development and commercialization rights for Idefirix in Europe, the United Kingdom, and the MENA region to SERB Pharmaceuticals.
US Imlifidase Opportunity
Hansa is seeking US approval of imlifidase for highly sensitized kidney-transplant patients based on the pivotal Phase 3 ConfIdeS study. The program is under FDA review, while Hansa retains responsibility for preparing the potential US launch and building the required medical, market-access, and commercial infrastructure.
Broader Enzyme Pipeline
The company is extending antibody-cleaving technology beyond kidney transplantation. A partner-led Phase 2 study with Genethon is evaluating imlifidase as a pretreatment intended to enable gene therapy in patients with Crigler-Najjar syndrome. HNSA-5487, a next-generation IgG-cleaving enzyme, is being prepared for clinical development in Guillain-Barre syndrome.
未来催化剂
- Publication of the Phase 3 ConfIdeS results in a leading medical journal in the second half of 2026.
- Submission of the application to convert Idefirix from conditional to full European marketing authorization in the fourth quarter of 2026.
- Completion of enrollment in the global Phase 2 Crigler-Najjar gene-therapy study by the end of 2026.
- FDA PDUFA decision for imlifidase in highly sensitized kidney-transplant patients on December 19, 2026.
- Submission of an IND for HNSA-5487 in Guillain-Barre syndrome by the end of 2026.
近期新闻
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