SABS Receives FDA Fast Track Designation for Type 1 Diabetes Therapy SAB-142

SAB Biotherapeutics announced it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its lead candidate, SAB-142. The designation is for the development of SAB-142 as a potentially disease-modifying immunotherapy for individuals with new-onset Stage 3 type 1 diabetes (T1D).

Key Details

• Designation: The FDA's Fast Track designation is intended to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need.
• Clinical Program: SAB-142 is currently being evaluated in a registrational Phase 2b clinical trial (SAFEGUARD).
• Projected Timeline: Enrollment for the Phase 2b study is expected to be completed in Q4 2026, with topline data anticipated in the second half of 2027.