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Hansa Biopharma AB ( (SE:HNSA) ) just unveiled an announcement.
Hansa Biopharma has submitted a Biologics License Application to the U.S. Food and Drug Administration for imlifidase as a desensitization treatment for highly sensitized adult patients undergoing deceased donor kidney transplantation, and has requested priority review following Fast Track and Orphan Drug designations. The application is backed by the pivotal U.S. Phase 3 ConfIdeS trial, which showed significantly improved kidney function and dialysis independence at 12 months versus control, reinforcing imlifidase’s potential to reshape access to transplantation for this hard‑to‑treat population and to expand Hansa’s presence in the U.S. renal transplant market if approval is granted.
The most recent analyst rating on (SE:HNSA) stock is a Buy with a SEK111.00 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 Sweden-based biopharmaceutical company focused on developing immunomodulatory enzyme therapies, notably imlifidase, to enable organ transplantation and treat rare immunologic diseases. Its lead product, marketed as IDEFIRIX in parts of Europe and other regions, targets highly sensitized kidney transplant candidates who face limited access to compatible donor organs.
Average Trading Volume: 795,627
Technical Sentiment Signal: Sell
Current Market Cap: SEK2.84B
For detailed information about HNSA stock, go to TipRanks’ Stock Analysis page.