Recent Updates — SABS

The U.S. Food and Drug Administration has granted Fast Track designation to SAB-142, a potentially disease-modifying immunotherapy being developed by SAB Biotherapeutics for the treatment of individuals with new-onset Stage 3 type 1 diabetes (T1D). This designation is intended to facilitate the development and expedite the review of therapies for serious conditions where there is an unmet medical need. The drug is currently being evaluated in the registrational Phase 2b SAFEGUARD study, with enrollment expected to be completed in Q4 2026 and topline data anticipated in 2H 2027. SAB Biotherapeutics is a clinical-stage biopharmaceutical company focused on developing multi-specific, high-potency human immunoglobulin G therapies for immune and autoimmune disorders.