Hansa Biopharma has reported a 135% increase in fourth-quarter revenue and confirmed submission of a Biologics License Application (BLA) to the FDA for imlifidase in highly sensitised patients awaiting kidney transplantation.

Revenue for Q4 2025 totalled 76.0 MSEK (million Swedish Kroner), up from 32.3 MSEK in Q4 2024. Product sales of IDEFIRIX reached 61.1 MSEK during the quarter, representing a 139% increase compared with 25.6 MSEK in the same period last year.

For the full year 2025, revenue totalled 222.3 MSEK, a 30% increase from 171.3 MSEK in 2024. Full-year IDEFIRIX product sales reached 204.7 MSEK, up 46% from 140.1 MSEK the previous year. The company attributed the growth to continued uptake across major European markets in the treatment of highly sensitised patients undergoing kidney transplantation.

Operating loss for Q4 2025 was 124.9 MSEK compared with 174.2 MSEK in Q4 2024. Full-year operating loss narrowed to 520.7 MSEK from 637.9 MSEK in 2024. Cash and short-term investments at the end of the period totalled 701.1 MSEK, compared with 405.3 MSEK at the end of 2024. During the quarter, Hansa completed a directed share issue raising 671.5 MSEK.

Renée Aguiar-Lucander, CEO of Hansa Biopharma, said: “Q4 capped a strong year for Hansa Biopharma. Filing our BLA with the FDA just three months after announcing Phase 3 results highlights the strength of our team and execution focus. We delivered solid growth in Europe, advanced market access efforts, and made the strategic decision to progress our next-generation enzyme HNSA-5487 in Guillain-Barré syndrome, with FDA interactions planned for the first half of 2026.”

She added that the company’s priorities for 2026 include securing FDA approval, preparing for a potential US launch of imlifidase, and expanding commercial adoption in Europe.

In December, the company submitted a BLA to the FDA for imlifidase for the desensitisation of highly sensitised adult patients undergoing deceased donor kidney transplantation. The FDA is reviewing the application for acceptability and assessing Hansa’s request for Priority Review, which could result in a PDUFA target date in August 2026.

Beyond transplantation, imlifidase is being evaluated in gene therapy settings. Initial data from the first patient in the GNT-018-IDES trial, presented at the European Society of Gene and Cell Therapy, showed removal of anti-AAV antibodies, potentially enabling gene therapy in patients with Crigler–Najjar syndrome who have pre-formed antibodies.

Hansa is also advancing HNSA-5487, a next-generation enzyme, in Guillain-Barré syndrome, with planned FDA interactions in the first half of 2026 to define the clinical development programme.

The company ended the year with 125 employees, compared with 135 at the end of 2024.