{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-24-132585","form_type":"8-K","ticker":"IVVD","cik":"0001832038","company_name":"Invivyd, Inc.","filed_at":"2024-05-07T23:59:59+00:00","discovered_at":"2026-05-14T18:03:20.550140+00:00","generated_at":"2026-06-02T19:55:49.001583+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Invivyd to pursue EUA for pemivibart for COVID-19 treatment in immunocompromised","bullets":["Plans EUA submission for pemivibart to treat mild-to-moderate COVID-19 in moderately-to-severely immunocompromised people via immunobridging pathway.","Immunobridging relies on Phase 2/3 STAMP trial data with adintrevimab and ongoing CANOPY trial for pemivibart PrEP.","Manufacturing plan targets ~100,000 doses available through H2 2024 to serve both PrEP and potential treatment uses.","2024 net product revenue guidance remains $150-200M; year-end cash at least $75M, excluding potential treatment sales.","After EUA submission, plans to initiate confirmatory safety, PK, and clinical virology trial."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-24-132585","json":"https://secwatch.observer/filing/0001193125-24-132585.json","markdown":"https://secwatch.observer/filing/0001193125-24-132585.md","text":"https://secwatch.observer/filing/0001193125-24-132585.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1832038/000119312524132585/0001193125-24-132585-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1832038/000119312524132585/d823090d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-02T19:55:49.001583+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"}