Biotech company Hansa Biopharma has announced that the U.S. Food and Drug Administration (FDA) has established a target date under the Prescription Drug User Fee Act (PDUFA) for the company's application for marketing approval of its drug imlifidase.

The target decision date is set for December 19, 2026, according to a press release.

"With a set PDUFA date, we are one step closer to potentially offering imlifidase as a transformative treatment option for patients who currently have very limited access to life-changing kidney transplantation. This marks an important milestone for Hansa Biopharma and for the highly sensitized patients in the U.S. who are waiting for a transplant," commented Renée Aguiar-Lucander, CEO of Hansa Biopharma.