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Hansa Biopharma Achieves Key Milestone in Kidney Transplantation

Hansa Biopharma AB, based in Lund, Sweden, reported significant progress in their clinical research and financial performance for the third quarter of 2025. Their interim report, released on October 30, revealed extremely promising results from the company's Phase 3 pivotal study of Imlifidase, a treatment aimed at kidney transplantation for highly sensitized patients.

Clinical Achievements in Q3 2025

In the ConfIdeS trial, Imlifidase successfully met its primary endpoint at the 12-month mark, demonstrating a mean estimated glomerular filtration rate (eGFR) of 51.5 mL/min/1.73m² compared to just 19.3 mL/min/1.73m² in the control group. This crucial achievement indicates a statistically significant improvement (p<0.0001) in kidney transplantation outcomes for patients who often face severe challenges due to heightened sensitization.

Renée Aguiar-Lucander, the CEO of Hansa Biopharma, expressed enthusiasm about the results, underscoring their potential to transform the lives of patients dependent on dialysis with limited transplantation options. The company plans to submit a Biologics License Application (BLA) to the FDA by the end of 2025, aiming for accelerated approval and Priority Review status.

Additionally, the confidence in Imlifidase's effectiveness is reinforced by supportive clinical findings from other ongoing trials, including two gene therapy studies that underscore Imlifidase's ability to reduce anti-AAV antibodies significantly, thus facilitating advanced treatments like gene therapy in conditions such as Duchenne muscular dystrophy (DMD).

Financial Performance Overview

The financial report illustrates that Hansa Biopharma achieved product sales totaling 143.6 MSEK year-to-date, representing an impressive year-on-year increase of 25.4%. However, the third quarter saw sales dip to 30.1 MSEK compared to 39.8 MSEK during the same period last year, largely due to seasonal influences on kidney transplants and challenges concerning reimbursement processes in Spain.

Despite these fluctuations, Hansa Biopharma maintains optimism for long-term growth, citing several initiatives planned for the fourth quarter designed to optimize their market opportunities and enhance performance into 2026 and beyond.

Looking Ahead: Growth and Development

The company remains committed to strengthening its market presence, with a strategic focus on leveraging the efficacy of their products such as Imlifidase in treating both kidney transplant patients and enabling gene therapies. Hansa Biopharma is also advancing its research and clinical offerings which position them as a leader in developing innovative therapies directed at serious unmet medical needs.

During a conference call held post-announcement, key executives including Aguiar-Lucander discussed the implications of these results and future plans, providing valuable insights into the company's trajectory in the biopharmaceutical landscape.

Investors and stakeholders are encouraged to stay connected with Hansa Biopharma as they continue to break ground in the field of transplantation and precision therapies, offering hope to countless patients worldwide.

For more information about their pioneering work and upcoming milestones, visit Hansa Biopharma's official website.

Conclusion

With a strong quarterly report and groundbreaking clinical trial outcomes, Hansa Biopharma is at the forefront of transformational therapies in kidney transplantation. The anticipation surrounding their pipeline products reflects both their commitment to patients and the vast potential in biopharmaceutical innovations for tackling rare and complex diseases.