{"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","discovered_at":"2026-05-14T18:03:41.001171+00:00","generated_at":"2026-06-16T23:52:19.796034+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"SAB Biotherapeutics receives FDA Breakthrough Therapy Designation for influenza therapeutic SAB-176","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-23-010655","json":"https://secwatch.observer/filing/0001437749-23-010655.json","markdown":"https://secwatch.observer/filing/0001437749-23-010655.md","text":"https://secwatch.observer/filing/0001437749-23-010655.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-16T23:52:19.796034+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}