SAB Biotherapeutics, Inc. announced on October 13, 2026, that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its candidate, SAB-142. The designation applies to the treatment of individuals with new-onset Stage 3 type 1 diabetes (T1D).
Fast Track designation is intended to facilitate the development and expedite the review of therapies for serious conditions where there is an unmet medical need. The company stated that the designation reflects the agency's determination that the program has the potential to address this unmet need.
SAB-142 is a fully human anti-thymocyte immunoglobulin (hATG) being developed as a potentially disease-modifying immunotherapy. The candidate is currently being evaluated in the registrational Phase 2b SAFEGUARD study. This trial is enrolling patients within 100 days of a Stage 3 T1D diagnosis. Enrollment for the SAFEGUARD study is expected to be completed in the fourth quarter of 2026, with topline data anticipated in the second half of 2027.
Additionally, the company noted that the SAB-142 program is supported by an investigator-led Phase 3 study named PRISE-hATG. This Phase 3 trial is designed to evaluate SAB-142 in people with Stage 3 type 1 diabetes from 100 days to two years following diagnosis.
In a statement regarding the designation, Samuel J. Reich, Chief Executive Officer of SAB Biotherapeutics, stated, 'Receiving FDA Fast Track designation is an important regulatory milestone for SAB-142 and reflects the agency's determination that the program has the potential to address an unmet medical need for people diagnosed with type 1 diabetes.'
