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 AB (HNSA) news covers developments at a commercial-stage biopharmaceutical company focused on rare immunological conditions. Based in Lund, Sweden, with operations in Europe and the U.S., Hansa Biopharma reports on progress across its proprietary IgG-cleaving enzyme technology platform, including transplantation, autoimmune diseases and gene therapy applications.
News for HNSA frequently highlights clinical and regulatory milestones for imlifidase, a first-in-class IgG antibody-cleaving enzyme therapy that has been shown to enable kidney transplantation in highly sensitized patients. Updates include data from the pivotal U.S. Phase 3 ConfIdeS trial in kidney transplantation, long-term follow-up analyses of imlifidase-enabled transplants, and the company’s submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration for desensitization of highly sensitized adult patients undergoing deceased donor kidney transplantation.
Investors following HNSA news can also expect information on IDEFIRIX product performance in approved markets, progress of next-generation asset HNSA-5487, and updates from gene therapy-related studies where imlifidase is used to reduce anti-AAV antibodies. Company announcements regularly cover participation in scientific congresses, virtual scientific and investor events, and corporate developments such as executive appointments and financing transactions.
This news feed provides a centralized view of Hansa Biopharma’s disclosures on its clinical programs, regulatory interactions, commercial activities and strategic initiatives linked to its IgG-cleaving enzyme platform. Readers interested in HNSA stock and the company’s role in rare immunological conditions can use this page to monitor key trial readouts, regulatory milestones and other material company updates over time.
Hansa Biopharma (NASDAQ STOCKHOLM:HNSA) reported positive topline results from the European 20-HMedIdeS-19 post authorization efficacy study of Idefirix (imlifidase) in highly sensitized kidney transplant patients.
One-year graft failure-free survival was 90%, with graft survival 92%, patient survival 98%, and mean eGFR 52.4 mL/min/1.73 m². Safety was generally consistent with prior trials, fulfilling the post-authorization obligation and supporting a planned EMA submission for full marketing authorization by end of 2026.
Hansa Biopharma (NASDAQ Stockholm:HNSA) announced that 12‑month results from its US Phase 3 ConfIdeS kidney transplant trial were selected as a late‑breaking abstract for oral presentation at the American Transplant Congress (ATC) in Boston on June 22, 2026.
The talk will cover primary endpoint eGFR, key secondary endpoints, and safety, presented by Dr Robert Montgomery.
Hansa Biopharma (NASDAQ Stockholm: HNSA) signed an exclusive licensing deal with SERB Pharmaceuticals for IDEFIRIX (imlifidase) in the EU, UK, Switzerland, Norway, Liechtenstein, Iceland and MENA.
Hansa will receive €110 million upfront plus €5 million on EMA filing acceptance. Completion is expected within 60 days, subject to FDI approval.
Hansa Biopharma (NASDAQ: HNSA) published its 2025 Annual and Sustainability Reports on March 26, 2026, highlighting a pivotal U.S. Phase 3 win for imlifidase (ConfIdeS, p<0.0001) and a December 2025 BLA submission to FDA under the accelerated pathway. Europe IDEFIRIX revenue rose 46% and the company raised ~USD 96 million while completing a debt restructuring to support U.S. launch readiness and pipeline advancement.
Hansa Biopharma (Nasdaq Stockholm: HNSA) announced the FDA has set a PDUFA action date of December 19, 2026 for the previously accepted BLA for imlifidase.
If approved, imlifidase would be the first treatment targeting highly sensitized patients awaiting kidney transplantation in the U.S. The company said it will work with the FDA as the agency completes its review.
Hansa Biopharma (Nasdaq: HNSA) announced the U.S. FDA accepted its Biologics License Application for imlifidase on Feb 18, 2026.
The FDA completed its 60-day filing review; Hansa expects a 74-Day Letter outlining review plans and timelines. The BLA is supported by a positive pivotal U.S. Phase 3 ConfIdeS trial showing significant 12-month eGFR and dialysis-independence benefits.
Imlifidase rapidly inactivates >95% of donor-specific IgG antibodies within 2–6 hours and was generally well tolerated in trials.
Hansa Biopharma (Nasdaq: HNSA) reported strong Q4 2025 results with Q4 revenue 76.0 MSEK (up 135% YoY) and IDEFIRIX product sales of 61.1 MSEK (up 139% YoY). The company submitted a BLA for imlifidase to the FDA and completed a directed share issue raising 671.5 MSEK, leaving cash and short-term investments of 701.1 MSEK.
Full-year 2025 revenue was 222.3 MSEK (up 30% YoY); net loss narrowed to 529.3 MSEK. Hansa advances imlifidase programs and plans FDA interactions for HNSA-5487 in 1H 2026.
Hansa Biopharma (NASDAQ: HNSA) won the 2025 SwedenBIO Award, presented at the SwedenBIO Summit in Stockholm on 21 January 2026. The award recognized Hansa for converting Swedish scientific excellence into global medical impact, building commercial capabilities for global markets, and advancing enzyme technology that enables transplantation for highly sensitized patients.
The company noted strong clinical progress, referencing U.S. Phase 3 data, an upcoming FDA review process, and an anticipated European Phase 3 readout later in 2026. CEO Renée Aguiar-Lucander said the award reflects momentum heading into 2026 and honored the Hansa team.
Hansa Biopharma (NASDAQ: HNSA) submitted a Biologics License Application (BLA) to the FDA on Dec 19, 2025 for imlifidase to enable desensitization of highly sensitized adult patients undergoing deceased-donor kidney transplantation.
The BLA is supported by the pivotal US Phase 3 ConfIdeS trial which met its primary endpoint with significantly improved 12‑month kidney function by mean eGFR (p < 0.0001) and a key secondary endpoint of 12‑month dialysis independence (p = 0.0007). FDA has granted Fast Track and Orphan Drug Designation; Hansa has requested Priority Review, which if granted could allow approval as early as Q3 2026.
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.