---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-23-010220"
form_type: "8-K"
ticker: "SABS"
cik: "0001833214"
company_name: "SAB Biotherapeutics, Inc."
filed_at: "2023-04-14T23:59:59+00:00"
generated_at: "2026-06-17T02:08:29.973498+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# SAB Biotherapeutics receives FDA Fast Track Designation for SAB-176 influenza immunotherapy for high-risk patients

## Summary
- Fast Track Designation granted for SAB-176, an investigational therapeutic for Type A and B influenza in high-risk patients, including those with antiviral-resistant strains.
- FDA aligned on Phase 2b trial design evaluating safety and efficacy in high-risk patients; manufacturing approach also aligned.
- SAB-176 is a fully-human polyclonal IgG antibody produced without human donors via the DiversitAb platform.
- Phase 2a data showed broad cross-protection against multiple influenza strains, including non-targeted strains.
- The designation enables frequent FDA interactions, priority review, and rolling review eligibility.

## SEC filing metadata
- accession: 0001437749-23-010220
- form_type: 8-K
- ticker: SABS
- cik: 0001833214
- company_name: SAB Biotherapeutics, Inc.
- filed_at: 2023-04-14T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1833214/000143774923010220/0001437749-23-010220-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1833214/000143774923010220/sabs20230413_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-23-010220
- JSON: https://secwatch.observer/filing/0001437749-23-010220.json
- Plain text: https://secwatch.observer/filing/0001437749-23-010220.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.