{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-24-117934","form_type":"8-K","ticker":"IVVD","cik":"0001832038","company_name":"Invivyd, Inc.","filed_at":"2024-10-29T23:59:59+00:00","discovered_at":"2026-05-14T18:03:09.909419+00:00","generated_at":"2026-05-30T09:23:05.052947+00:00","sec_items":["2.02","8.01","9.01"],"event_type":"earnings","sentiment":"negative","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Invivyd reports preliminary Q3 2024 PEMGARDA revenue of $9.3M, withdraws 2024 guidance, targets 1H 2025 profitability","bullets":["Preliminary Q3 2024 PEMGARDA net product revenue of $9.3M; cash and equivalents ~$107M as of Sept 30.","Withdraws prior 2024 revenue guidance of $150-200M citing late-Q3 FDA Fact Sheet warning on pemivibart activity.","Targets near-term profitability in 1H 2025 using existing cash, anticipated revenue growth, and operational efficiencies.","Phase 3 CANOPY data: PEMGARDA provided 64% RRR vs placebo in months 7-12, total 12-month RRR 76% (nominal p<0.0001).","Expects to end 2024 with $65M+ cash; no new safety signals in months 7-12 follow-up."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-24-117934","json":"https://secwatch.observer/filing/0000950170-24-117934.json","markdown":"https://secwatch.observer/filing/0000950170-24-117934.md","text":"https://secwatch.observer/filing/0000950170-24-117934.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1832038/000095017024117934/0000950170-24-117934-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1832038/000095017024117934/ivvd-20241029.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-30T09:23:05.052947+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"}