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Hansa Biopharma Delivers Strong Q4 Growth and Files FDA Application for Imlifidase

Story Highlights
  • Hansa Biopharma posted strong Q4 and full-year revenue growth, driven by IDEFIRIX sales expansion in Europe and reinforced its finances with a sizable share issue despite ongoing operating losses.
  • The company advanced its rare disease pipeline by filing a U.S. BLA for imlifidase in kidney transplant desensitization, progressing gene therapy pre-treatment and GBS programs, while facing a Phase 3 setback in anti-GBM disease.
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Hansa Biopharma Delivers Strong Q4 Growth and Files FDA Application for Imlifidase

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An announcement from Hansa Biopharma AB ( (SE:HNSA) ) is now available.

Hansa Biopharma reported a strong fourth quarter, with revenue rising 135% year-on-year to 76.0 MSEK and full-year revenue reaching 222.3 MSEK, driven by 46% growth in IDEFIRIX product sales and broader uptake across key European markets, including Germany and progress on temporary funding in Catalunya, Spain. The company strengthened its balance sheet via a directed share issue of about 671.5 MSEK, reorganized its European and international commercial and medical affairs leadership, and ended the year with 701.1 MSEK in cash and short-term investments, while still posting a full-year loss of 529.3 MSEK as it invests in pipeline expansion.

Strategically, Hansa submitted a Biologics License Application to the U.S. FDA for imlifidase in desensitization of highly sensitized kidney transplant candidates, with a potential priority review decision that could set a PDUFA date as early as August 2026 and a European confirmatory PAES trial readout expected mid-2026. The clinical portfolio advanced with initial data from the GNT-018-IDES gene therapy pre-treatment trial in Crigler–Najjar syndrome demonstrating rapid AAV antibody removal, a decision to progress HNSA-5487 into Guillain-Barré syndrome following planned FDA discussions, and a setback in the anti-GBM Phase 3 study where the primary endpoint was not met due to unexpectedly strong outcomes from optimized standard of care, underscoring both the promise and risk in Hansa’s rare disease pipeline for investors and patients.

The most recent analyst rating on (SE:HNSA) stock is a Hold with a SEK36.00 price target. To see the full list of analyst forecasts on Hansa Biopharma AB stock, see the SE:HNSA Stock Forecast page.

More about Hansa Biopharma AB

Hansa Biopharma AB is a commercial-stage biopharmaceutical company focused on developing and commercializing innovative, life-saving and life-altering treatments for patients with rare immunological conditions. Its pipeline is built around a proprietary IgG-cleaving enzyme platform, with lead applications in transplantation desensitization, autoimmune diseases, gene therapy and other areas of high unmet medical need, and operations spanning Europe and the U.S.

Average Trading Volume: 520,497

Technical Sentiment Signal: Buy

Current Market Cap: SEK3.69B

For an in-depth examination of HNSA stock, go to TipRanks’ Overview page.

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