SAB Biotherapeutics gets FDA Fast Track for T1D therapy SAB-142

SAB Biotherapeutics, Inc. announced on October 13, 2026 that the FDA granted Fast Track designation to SAB-142, a fully human anti-thymocyte immunoglobulin being developed for the treatment of individuals with new-onset Stage 3 type 1 diabetes.¹

Fast Track designation is intended to facilitate development and expedite review of therapies for serious conditions with unmet medical need, with the goal of bringing important new treatments to patients earlier.¹

SAB BIO Chief Executive Officer Samuel J. Reich said the designation marks a regulatory milestone, stating that it reflects the agency's determination that the program has the potential to address an unmet medical need for people diagnosed with type 1 diabetes.¹

On the clinical timeline, the company said SAB-142 is currently being evaluated in the registrational Phase 2b SAFEGUARD study in people within 100 days of a Stage 3 T1D diagnosis, with enrollment expected to be completed in Q4 2026 and topline data anticipated in 2H 2027.¹ The program also includes a separate trial, as the investigator-led Phase 3 PRISE-hATG study, which is designed to evaluate SAB-142 in people with Stage 3 type 1 diabetes from 100 days to two years following diagnosis.¹

The company describes its broader technology platform as one built around developing multi-specific, high-potency, human immunoglobulin G to treat and prevent immune and autoimmune disorders, using advanced genetic engineering and antibody science to generate therapeutic candidates without the need for human donors or convalescent plasma.¹ SAB BIO states that SAB-142, its lead candidate, targets autoimmune T1D with a disease-modifying therapeutic approach that aims to change the T1D treatment paradigm by delaying onset and potentially preventing disease progression of Stage 3 T1D patients.¹