{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-295539","form_type":"8-K","ticker":"IVVD","cik":"0001832038","company_name":"Invivyd, Inc.","filed_at":"2026-07-06T11:11:45+00:00","discovered_at":"2026-07-06T11:15:00.240148+00:00","generated_at":"2026-07-06T11:15:06.250825+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Invivyd receives FDA notice of PEMGARDA EUA termination effective June 29, 2027; plans to pursue BLA approval","bullets":["FDA sent Invivyd Notice of Termination for PEMGARDA EUA, effective June 29, 2027, following HHS termination of COVID-19 EUA declaration.","PEMGARDA (pemivibart) authorized since March 2024 for COVID-19 pre-exposure prophylaxis in immunocompromised individuals.","Invivyd intends to pursue Biologics License Application (BLA) for full FDA approval, citing clinical and post-authorization data.","Company is in active dialogue with FDA on next steps; HHS has not provided specific written advice on approval pathway.","Chairman Marc Elia states PEMGARDA has sufficient data for BLA submission and approval."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-295539","json":"https://secwatch.observer/filing/0001193125-26-295539.json","markdown":"https://secwatch.observer/filing/0001193125-26-295539.md","text":"https://secwatch.observer/filing/0001193125-26-295539.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1832038/000119312526295539/0001193125-26-295539-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1832038/000119312526295539/ivvd-20260706.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-07-06T11:15:06.250825+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"}