Hansa Biopharma Secures FDA PDUFA Date for Imlifidase in High-Risk Kidney Transplant Patients

Hansa Biopharma AB ( (SE:HNSA) ) has shared an update.

Hansa Biopharma has received a Prescription Drug User Fee Act (PDUFA) action date of December 19, 2026, from the U.S. Food and Drug Administration for the Biologics License Application of its drug imlifidase. If approved, imlifidase would become the first treatment option in the U.S. specifically targeting highly sensitized kidney transplant candidates, a patient group that makes up an estimated 10–15% of transplant waiting lists and often faces indefinite dialysis due to donor incompatibility.

Imlifidase, already conditionally approved in several European markets and authorized in Australia and Switzerland under the brand IDEFIRIX, is designed to rapidly cleave IgG antibodies and reduce the immunological barriers that block transplantation. The U.S. regulatory milestone strengthens Hansa Biopharma’s position in the transplant immunology space and underscores the potential to expand access to life‑changing kidney transplants for patients who currently have limited therapeutic alternatives and prolonged waiting times.

The most recent analyst rating on (SE:HNSA) stock is a Buy with a SEK103.00 price target. To see the full list of analyst forecasts on Hansa Biopharma AB stock, see the SE:HNSA Stock Forecast page.

More about Hansa Biopharma AB

Hansa Biopharma AB is a commercial-stage biopharmaceutical company developing and commercializing novel immunomodulatory therapies for acute and complex immune disorders. Built around a proprietary IgG-cleaving enzyme platform, its portfolio includes imlifidase for highly sensitized kidney transplant patients and next‑generation candidate HNSA-5487 for Guillain-Barré Syndrome, with operations in Europe and the U.S. and a listing on Nasdaq Stockholm.

Average Trading Volume: 505,463

Technical Sentiment Signal: Sell

Current Market Cap: SEK3.14B

For a thorough assessment of HNSA stock, go to TipRanks’ Stock Analysis page.