Hansa Biopharma reports positive efficacy and safety results from Idefirix® European post authorization study in kidney transplantation

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Hansa Biopharma reports positive efficacy and safety results from Idefirix® European post authorization study in kidney transplantation

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Idefirix met its primary objective in the European post-authorization efficacy study, achieving 90% one-year graft failure-free survival in highly sensitized kidney transplant patients. — Positive primary endpoint results in a confirmatory study significantly reduce clinical risk and validate the drug's commercial viability.

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Hansa Biopharma plans to submit an application to the EMA for the conversion of Idefirix from conditional to full marketing authorization by the end of 2026. — Transitioning to full marketing authorization removes regulatory uncertainty and strengthens the long-term market position of the product.

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The study reported a safety profile for Idefirix that is consistent with prior clinical experience and was generally well tolerated. — Confirmation of a known safety profile prevents negative surprises but does not add new catalyst value.

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Hansa Biopharma reports positive efficacy and safety results from Idefirix® European post authorization study in kidney transplantation

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Hansa Biopharma reports positive efficacy and safety results from Idefirix® European post authorization study in kidney transplantation

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