---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-23-010655"
form_type: "8-K"
ticker: "SABS"
cik: "0001833214"
company_name: "SAB Biotherapeutics, Inc."
filed_at: "2023-04-19T23:59:59+00:00"
generated_at: "2026-06-16T23:52:19.796034+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# SAB Biotherapeutics receives FDA Breakthrough Therapy Designation for influenza therapeutic SAB-176

## Summary
- FDA granted Breakthrough Therapy Designation to SAB-176 for post-exposure prophylaxis of Type A/B influenza in high-risk patients.
- SAB-176 previously received Fast Track designation on April 13, 2023; both designations rarely obtained together.
- Breakthrough Therapy provides intensive FDA guidance, eligibility for priority review, and expedited development.
- SAB-176 is a fully human multi-epitope binding polyclonal antibody, reducing risk of viral escape mutations.
- Phase 2b dose-ranging efficacy and safety trial planned following FDA regulatory alignment.

## SEC filing metadata
- accession: 0001437749-23-010655
- form_type: 8-K
- ticker: SABS
- cik: 0001833214
- company_name: SAB Biotherapeutics, Inc.
- filed_at: 2023-04-19T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1833214/000143774923010655/0001437749-23-010655-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1833214/000143774923010655/sabs20230418_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-23-010655
- JSON: https://secwatch.observer/filing/0001437749-23-010655.json
- Plain text: https://secwatch.observer/filing/0001437749-23-010655.txt

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