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FDA accepts Hansa Biopharma BLA for imlifidase, with PDUFA date set for Dec. 19, 2026

Apr 23, 2026

The FDA accepted Hansa Biopharma’s BLA for imlifidase and set a PDUFA action date of Dec. 19, 2026. The filing is backed by Phase 3 ConfIdeS data showing statistically significant efficacy.

FDA Accepts Hansa Biopharma's BLA for Imlifidase in Kidney Transplantation

Feb 19, 2026

Hansa Biopharma announced on February 18, 2026 that the FDA has accepted its Biologics License Application for imlifidase, supported by positive Phase 3 ConfIdeS trial results in highly sensitized kidney transplant patients.