{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-25-008995","form_type":"8-K","ticker":"IVVD","cik":"0001832038","company_name":"Invivyd, Inc.","filed_at":"2025-01-27T23:59:59+00:00","discovered_at":"2026-05-14T18:03:05.155135+00:00","generated_at":"2026-05-27T09:23:08.274000+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 submits XEC variant data to FDA supporting pemivibart treatment EUA amendment","bullets":["Updated immunobridging analysis with XEC variant shows pemivibart titers substantially exceed adintrevimab in Days 0-5.","Adintrevimab previously showed 66-74% risk reduction in hospitalization/death vs placebo in STAMP trial.","No additional anaphylaxis reports during post-authorization use of PEMGARDA for COVID-19 PrEP to date.","Submission consistent with prior analyses since July 2024; FDA review ongoing with no statutory deadline."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-25-008995","json":"https://secwatch.observer/filing/0000950170-25-008995.json","markdown":"https://secwatch.observer/filing/0000950170-25-008995.md","text":"https://secwatch.observer/filing/0000950170-25-008995.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1832038/000095017025008995/0000950170-25-008995-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1832038/000095017025008995/ivvd-20250127.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-27T09:23:08.274000+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"}