LUND, Sweden - Hansa Biopharma AB (NASDAQ Stockholm: HNSA) announced that results from its U.S. Phase 3 ConfIdeS trial in kidney transplantation have been accepted for presentation at the American Transplant Congress in Boston on June 22, 2026.
The presentation will include 12-month results from the ConfIdeS trial, including the primary endpoint eGFR, key secondary endpoints, and safety results. Dr. Robert Montgomery from New York University Langone Transplant Institute will deliver the presentation.
The abstract, titled "Superior 1-year eGFR Among Highly Sensitized Patients Desensitized with Imlifidase Compared with Control," is scheduled for Monday, June 22, 2026, from 15:57 to 16:09 EDT at the Thomas Michael Menino Convention and Exhibition Center.
The trial studied imlifidase, marketed as IDEFIRIX in Europe, an antibody-cleaving enzyme targeting immunoglobulin G antibodies. The drug has conditional marketing approval in the EU, Norway, Liechtenstein, Iceland, and the UK for desensitization of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor. It is also approved in Australia, Israel, and Switzerland.
In the U.S., the FDA accepted the Biologics License Application for imlifidase in February 2026 and assigned a PDUFA action date of December 19, 2026.
The company's stock has responded positively, delivering a 37% return over the past year. With a market cap of $377 million and analyst price targets as high as $11.09, investor interest remains strong despite current unprofitability.
Highly sensitized patients have pre-formed donor-specific antibodies that can cause tissue damage and potential transplant rejection. These patients comprise around 10-15% of patients on transplant waiting lists in the U.S. and Europe.
Hansa Biopharma is a commercial-stage biopharmaceutical company based in Lund, Sweden, with operations in Europe and the U.S.
