SAB BIO Receives FDA Fast Track Designation for SAB-142 in Stage 3 Type 1 Diabetes
Key Highlights
- ➤SAB-142 (SABS) receives FDA Fast Track designation for Stage 3 type 1 diabetes
- ➤SAFEGUARD Phase 2b enrollment expected to complete in Q4 2026
- ➤SAFEGUARD topline data anticipated in 2H 2027
- ➤PRISE-hATG Phase 3 study evaluates patients 100 days to two years post-diagnosis
Expert Statements
Samuel J. Reich, Chief Executive Officer of SAB BIO
“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”
Samuel J. Reich, Chief Executive Officer of SAB BIO
“We look forward to continuing to work closely with the FDA as we advance the SAB-142 clinical program.”
Samuel J. Reich, Chief Executive Officer of SAB BIO
“This designation represents meaningful progress toward our goal of bringing SAB-142 to people living with type 1 diabetes as quickly as possible and transforming the meaning of a T1D diagnosis.”
Fast Track designation recognizes the potential of SAB-142 to address an unmet medical need for people with Stage 3 type 1 diabetes
MIAMI, Oct. 13, 2026 (GLOBE NEWSWIRE) -- SAB Biotherapeutics, Inc. (Nasdaq: SABS), a clinical-stage biopharmaceutical company developing a fully human anti-thymocyte immunoglobulin (hATG) for type 1 diabetes (T1D) and other autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to SAB-142, a potentially disease-modifying immunotherapy being developed for the treatment of individuals with new-onset Stage 3 T1D.
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