PDUFA Action Date for Hansa Biopharma’s Imlifidase BLA Set for December 19, 2026
If approved, imlifidase will be the first treatment to address highly sensitized patients awaiting kidney transplantation.
Lund, Sweden, 4 March 2026. Hansa Biopharma AB, (“Hansa” or “the Company”), (Nasdaq Stockholm: HNSA), today announced that the Food and Drug Administration (FDA) has notified the company that the previously accepted Biologics License Application (BLA) for imlifidase has been assigned a Prescription Drug User Fee Act (PDUFA) action date of December 19, 2026.
