# FDA Grants Fast Track Designation to SAB Biotherapeutics for Diabetes Treatment SAB-142

- URL: https://stocks.freetheai.org/news/fda-grants-fast-track-designation-to-sab-biotherapeutics-for-diabetes-treatment-944e35
- Published: 2026-10-13T12:43:00Z
- Category: company_news; sentiment: bullish; impact: medium
- Symbols: [NASDAQ:SABS](https://stocks.freetheai.org/symbols/NASDAQ-SABS)
- Written by our AI from expert market sources across the web for FreeTheAI Stocks, built by Vibhek Soni
- How write-ups are made: https://stocks.freetheai.org/how-we-write
- Not financial advice: https://stocks.freetheai.org/disclaimer

SAB Biotherapeutics, Inc. (SABS) received FDA Fast Track designation for SAB-142, an experimental immunotherapy designed to modify the progression of newly diagnosed Stage 3 type 1 diabetes. The regulatory status is intended to support the drug's clinical development process and speed up the agency's review timeline.

The candidate is currently being tested in the registrational Phase 2b SAFEGUARD trial, which focuses on patients diagnosed with Stage 3 type 1 diabetes within the past 100 days. Additionally, an investigator-led Phase 3 trial, named PRISE-hATG, is assessing the treatment in individuals up to two years after their diagnosis.

Patient enrollment for the SAFEGUARD study is on track to finish in the fourth quarter of 2026. Investors and clinical researchers are anticipating initial topline data from the Phase 2b trial in the second half of 2027.

## Key points

- The U.S. FDA granted Fast Track designation to SAB-142 for the treatment of Stage 3 type 1 diabetes.
- SAB-142 is being evaluated in the Phase 2b SAFEGUARD study for patients diagnosed within 100 days.
- Enrollment in the SAFEGUARD study is expected to finish in Q4 2026, with topline results due in 2H 2027.
- The program is also supported by an investigator-led Phase 3 study evaluating patients up to two years post-diagnosis.

## Questions and answers

### What is SAB-142?

SAB-142 is a potential disease-modifying immunotherapy being developed by SAB Biotherapeutics to treat new-onset Stage 3 type 1 diabetes.

### What does FDA Fast Track status mean for SAB Biotherapeutics?

The designation helps facilitate the development and expedite the review process for SAB-142 in Stage 3 type 1 diabetes.

### When will SAB Biotherapeutics report data from the SAFEGUARD study?

Topline data from the Phase 2b SAFEGUARD study is expected in the second half of 2027 following enrollment completion in Q4 2026.