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

- URL: https://stocks.freetheai.org/news/fda-grants-fast-track-designation-to-sab-biotherapeutics-for-diabetes-fb70da
- Published: 2026-10-13T12:30:00Z
- Category: company_news; sentiment: bullish; impact: medium
- Symbols: [NASDAQ:SABS](https://stocks.freetheai.org/symbols/NASDAQ-SABS)
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The U.S. Food and Drug Administration has granted Fast Track status to SAB Biotherapeutics, Inc. (SABS) for its experimental immunotherapy SAB-142, aimed at treating new-onset Stage 3 type 1 diabetes. The company's stock fell 5.03% to $2.83 in recent trading.

This regulatory designation helps accelerate clinical development and FDA review for therapies addressing high unmet medical needs. SAB-142 is a human anti-thymocyte globulin candidate intended to modify the course of type 1 diabetes.

SAB-142 is currently in a registrational Phase 2b trial. The company plans to finish enrolling patients by the fourth quarter of 2026 and expects to report topline data in the second half of 2027. The clinical program is supported by PRISE-hATG, an investigator-sponsored Phase 3 study.

## Key points

- SAB Biotherapeutics received FDA Fast Track designation for its type 1 diabetes candidate SAB-142.
- SAB-142 is a human anti-thymocyte globulin immunotherapy targeting new-onset Stage 3 type 1 diabetes.
- Patient enrollment in the registrational Phase 2b study is expected to complete in Q4 2026.
- Topline clinical trial results are anticipated during the second half of 2027.

## Questions and answers

### What regulatory status did SAB Biotherapeutics receive from the FDA?

The FDA granted Fast Track designation to SAB Biotherapeutics for SAB-142, an immunotherapy candidate for Stage 3 type 1 diabetes.

### When will SAB Biotherapeutics report Phase 2b trial data for SAB-142?

SAB Biotherapeutics expects to complete Phase 2b patient enrollment by the fourth quarter of 2026 and release topline data in the second half of 2027.