Also known as: cPRA
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.
The FDA has accepted Hansa Biopharma's Biologics License Application for imlifidase, a desensitization treatment for highly sensitized adult kidney transplant patients with positive crossmatch against deceased donors, with a PDUFA date of December 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.
