Hansa Biopharma ConfIdeS Trial Results
Analysis based on 6 articles · First reported May 25, 2026 · Last updated May 26, 2026
The announcement of positive Phase 3 trial results for Imflidase and its acceptance for presentation at a major congress is expected to positively impact GT Biopharma's stock price. The potential for US market approval, following the FDA's acceptance of the BLA, further enhances the market outlook for GT Biopharma and its drug, Imflidase.
GT Biopharma announced that the 12-month results from its US Phase 3 ConfIdeS trial for imlifidase in kidney transplantation have been accepted for an oral presentation at the American Transplant Congress on June 22, 2026. The presentation, to be delivered by Dr. Robert Montgomery (surgeon), will detail the primary endpoint eGFR, key secondary endpoints, and safety results, showing superior 1-year eGFR among highly sensitized patients desensitized with Imflidase. Imflidase is already conditionally approved in the European Union, Norway, Liechtenstein, Iceland, and the United Kingdom, and approved in Australia, Israel, and Switzerland. The United States — Food and Drug Administration accepted the Biologics License Application for Imflidase in February 2026, with a Prescription Drug User Fee Act action date of December 19, 2026.
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