Hansa Biopharma Submits BLA to FDA for Imlifidase in desensitization for Kidney Transplantation [Yahoo! Finance]
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Source: Yahoo! Finance
Imlifidase is an enzyme that rapidly and efficiently cleaves all types of immunoglobulin G (IgG) antibodies both intra- and extra-vascularly to inhibit IgG-mediated immune response FDA has granted Hansa Biopharma Fast Track and Orphan Drug Designation and Hansa has requested Priority Review LUND, Sweden Dec. 19, 2025 /PRNewswire/ -- Hansa Biopharma AB, ("Hansa" or "the Company"), (Nasdaq Stockholm: HNSA), today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for imlifidase. The Company is requesting priority review of the BLA for the use of imlifidase in the desensitization of highly sensitized adult patients undergoing deceased donor kidney transplantation. Renée Aguiar-Lucander, CEO, Hansa Biopharma said: "The submission of our BLA to the FDA marks a pivotal milestone for Hansa Biopharma and for highly sensitized patients living with end-stage renal disease in the US. If approved, imlifidase has the potential to
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