{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-050226","form_type":"8-K","ticker":"NVAX","cik":"0001000694","company_name":"NOVAVAX INC","filed_at":"2025-05-19T23:59:59+00:00","discovered_at":"2026-05-14T18:02:47.116416+00:00","generated_at":"2026-05-21T00:56:56.113661+00:00","sec_items":["7.01","8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Novavax receives FDA approval for Nuvaxovid COVID-19 vaccine; triggers $175M Sanofi milestone","bullets":["FDA approves BLA for Nuvaxovid for COVID-19 in adults 65+ and high-risk individuals 12-64.","Approval triggers $175M milestone payment from Sanofi under May 2024 Collaboration and License Agreement.","FDA requests new Phase 4 postmarketing efficacy trial in 50-64 age group without high-risk conditions; Novavax working with Sanofi on funding.","Novavax reiterates FY2025 R&D+SG&A guidance of $475-525M; projects ~$350M for FY2026 and ~$250M for FY2027.","Expects commercial delivery of 2025-2026 COVID-19 vaccine formula in US this Fall with Sanofi, pending VRBPAC recommendation May 22."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-050226","json":"https://secwatch.observer/filing/0001104659-25-050226.json","markdown":"https://secwatch.observer/filing/0001104659-25-050226.md","text":"https://secwatch.observer/filing/0001104659-25-050226.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1000694/000110465925050226/0001104659-25-050226-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1000694/000110465925050226/tm2515521d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-21T00:56:56.113661+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"}