{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-230898","form_type":"8-K","ticker":"IVVD","cik":"0001832038","company_name":"Invivyd, Inc.","filed_at":"2025-10-06T23:59:59+00:00","discovered_at":"2026-05-14T18:02:40.693036+00:00","generated_at":"2026-05-17T04:37:20.265678+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Invivyd announces FDA IND clearance for VYD2311; Phase 3 and Phase 2 trials to start year-end 2025","bullets":["FDA cleared IND and aligned on pivotal clinical program for VYD2311, a vaccine-alternative monoclonal antibody to prevent COVID.","DECLARATION Phase 3 trial (N=~2,000) will evaluate single and monthly IM doses vs placebo for 3-month prevention of symptomatic COVID.","LIBERTY Phase 2 trial (N=~300) will compare safety/tolerability of VYD2311 vs mRNA vaccine and explore co-administration.","Trials to begin year-end 2025 with top-line data anticipated mid-2026; funded by recent capital raise and commercial launch quantities ready.","Details to be shared in public investor event later this month."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-230898","json":"https://secwatch.observer/filing/0001193125-25-230898.json","markdown":"https://secwatch.observer/filing/0001193125-25-230898.md","text":"https://secwatch.observer/filing/0001193125-25-230898.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1832038/000119312525230898/0001193125-25-230898-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1832038/000119312525230898/ivvd-20251006.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T04:37:20.265678+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"}