{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-180890","form_type":"8-K","ticker":"IVVD","cik":"0001832038","company_name":"Invivyd, Inc.","filed_at":"2025-08-14T23:59:59+00:00","discovered_at":"2026-05-14T18:02:45.212454+00:00","generated_at":"2026-05-17T13:25:01.752893+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 aligns with FDA on rapid BLA pathway for VYD2311; Q2 revenue $11.8M, up 413% YoY","bullets":["Q2 2025 PEMGARDA net product revenue $11.8M, up 413% YoY; net loss $14.7M ($0.12/sh) vs $47.2M ($0.40/sh) in Q2 2024.","Cash and cash equivalents $34.9M as of June 30, 2025; near-term profitability target not met but possible with upcoming season.","FDA alignment on rapid BLA pathway for VYD2311; single Phase 2/3 trial with 12-week primary endpoint may support approval for COVID-19 prevention.","Pipeline expansion: RSV candidate identification expected Q3 2025, measles candidate by end of 2025.","VYD2311 safety data: 76-day half-life IM, attractive profile; quantities of commercial launch product available."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-180890","json":"https://secwatch.observer/filing/0001193125-25-180890.json","markdown":"https://secwatch.observer/filing/0001193125-25-180890.md","text":"https://secwatch.observer/filing/0001193125-25-180890.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1832038/000119312525180890/0001193125-25-180890-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1832038/000119312525180890/d936404d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T13:25:01.752893+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"}