{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-329488","form_type":"8-K","ticker":"IVVD","cik":"0001832038","company_name":"Invivyd, Inc.","filed_at":"2025-12-23T23:59:59+00:00","discovered_at":"2026-05-14T18:02:40.694285+00:00","generated_at":"2026-05-16T12:17:28.138088+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Invivyd receives FDA Fast Track designation for COVID antibody VYD2311","bullets":["FDA Fast Track granted for VYD2311 to prevent COVID in individuals with risk factors for severe disease.","VYD2311 is an investigational vaccine-alternative monoclonal antibody candidate.","Phase 3 DECLARATION trial ongoing; top-line data expected mid-2026.","Fast Track enables priority review and rolling BLA submission if criteria met.","Total enrollment of 1770 participants in the placebo-controlled trial."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-329488","json":"https://secwatch.observer/filing/0001193125-25-329488.json","markdown":"https://secwatch.observer/filing/0001193125-25-329488.md","text":"https://secwatch.observer/filing/0001193125-25-329488.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1832038/000119312525329488/0001193125-25-329488-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1832038/000119312525329488/ivvd-20251223.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T12:17:28.138088+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"}