Hansa Biopharma reports new data on Idefirix

Sweden-based Hansa Biopharma (Nasdaq Stockholm: HNSA) today announced positive top-line results from the European 20-HMedIdeS-19 Post Authorization Efficacy Study (PAES), an open-label confirmatory study investigating one-year graft failure-free survival and patient survival in highly sensitized patients who have undergone HLA-incompatible kidney transplantation following desensitization treatment with Idefirix (imlifidase).

Renée Aguiar-Lucander, chief executive of Hansa Biopharma, said: “These positive results represent a significant milestone for Idefirix and for Hansa. The one‑year graft failure‑free survival observed in this highly sensitized patient population confirms the clinical benefit of Idefirix and demonstrates expected efficacy outcomes supported by a safety profile consistent with prior clinical experience. With this post‑authorization requirement fulfilled, we look forward to submitting an application for conversion to full marketing authorization to the EMA by the end of 2026.”