{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-24-075582","form_type":"8-K","ticker":"IVVD","cik":"0001832038","company_name":"Invivyd, Inc.","filed_at":"2024-03-25T23:59:59+00:00","discovered_at":"2026-05-14T18:03:25.828740+00:00","generated_at":"2026-06-04T08:41:40.135650+00:00","sec_items":["2.02","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Invivyd gets FDA EUA for PEMGARDA as COVID-19 PrEP for immunocompromised; cash $200.6M","bullets":["FDA issued EUA for PEMGARDA (pemivibart) for pre-exposure prophylaxis of COVID-19 in adults/adolescents (≥12 yrs, ≥40 kg) with moderate-to-severe immune compromise.","Estimated cash and cash equivalents of $200.6M as of Dec 31, 2023 (preliminary, unaudited).","In Feb 2024, raised $40.5M gross proceeds from ATM share sales, strengthening balance sheet ahead of launch.","Immunobridging established: Day 28 calculated sVNA titer vs JN.1 was 7365 (90% CI: 7148–7589); ratio to reference 0.82 (0.80–0.85).","Anaphylaxis observed in 0.6% (4/623) of CANOPY participants; boxed warning and two-hour post-infusion monitoring required."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-24-075582","json":"https://secwatch.observer/filing/0001193125-24-075582.json","markdown":"https://secwatch.observer/filing/0001193125-24-075582.md","text":"https://secwatch.observer/filing/0001193125-24-075582.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1832038/000119312524075582/0001193125-24-075582-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1832038/000119312524075582/d801617d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-04T08:41:40.135650+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"}