18 Feb 2026, 19:53
Regulatory information

Lund, Sweden, 18 February 2026. Hansa Biopharma AB, ("Hansa" or "the Company"), (Nasdaq Stockholm: HNSA), today announced that its Biologics License Application (BLA) for imlifidase has been accepted by the U.S. Food and Drug Administration (FDA).

FDA's filing review was completed on day 60 which is meant to verify that the submission is substantially complete and meets the requirements for a full evaluation.

Renée Aguiar-Lucander, CEO, Hansa Biopharma said: "We now look forward to receiving the 74-Day Letter which will provide details regarding review plan, timelines and other pertinent information and start working with the FDA as they go through their review over the coming months."

Hansa Biopharma’s Biologics License Application (BLA) for imlifidase accepted by the FDA | Hansa Biopharma

(www.hansabiopharma.com)