{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-406007","form_type":"8-K","ticker":"IVVD","cik":"0001832038","company_name":"Invivyd, Inc.","filed_at":"2026-09-29T11:26:46+00:00","discovered_at":"2026-09-29T11:30:00.303614+00:00","generated_at":"2026-10-12T13:41:51.501837+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Invivyd's VYD2311 bests COMIRNATY on safety in LIBERTY Phase 3; BLA via Accelerated Approval planned","bullets":["LIBERTY randomized 210 healthy adults (18-49) 1:1:1 to 250mg VYD2311, COMIRNATY mRNA vaccine, or both; VYD2311 met all primary and secondary endpoints.","6-day TEAE/ISR/hypersensitivity: VYD2311 56.5% vs vaccine 91.4% (P<0.0001); 56-day rate 60.9% vs 91.4% (P<0.0001); combo arm 83.1% (P=0.21).","Systemic AEs at 6 days: 44.1% for VYD2311 vs 68.1% for mRNA vaccine (P=0.008); combination 50.0% vs 68.1% (P=0.023).","No VYD2311-related AE above Grade 2 and no hypersensitivity or anaphylaxis in any arm; co-administration raised vaccine neutralizing titers ~2.5x with no immunologic interference.","After a September Type C meeting, Invivyd plans a BLA under Accelerated Approval; DECLARATION safety/immunogenicity topline data expected in October, efficacy unblinded post-approval."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-406007","json":"https://secwatch.observer/filing/0001193125-26-406007.json","markdown":"https://secwatch.observer/filing/0001193125-26-406007.md","text":"https://secwatch.observer/filing/0001193125-26-406007.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1832038/000119312526406007/0001193125-26-406007-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1832038/000119312526406007/ivvd-20260929.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-12T13:41:51.501837+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"}