{"schema_version":"secwatch.filing_event.v1","accession":"0001682852-26-000012","form_type":"8-K","ticker":"MRNA","cik":"0001682852","company_name":"Moderna, Inc.","filed_at":"2026-02-11T23:59:59+00:00","discovered_at":"2026-05-14T18:02:35.884931+00:00","generated_at":"2026-05-16T03:20:08.162584+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Moderna receives FDA Refusal-to-File for flu vaccine mRNA-1010; no impact on 2026 guidance","bullets":["FDA CBER refused to review BLA for mRNA-1010 citing comparator choice, not safety/efficacy.","Moderna states RTF letter contradicts prior written feedback from pre-Phase 3 and pre-submission meetings.","Moderna has requested a Type A meeting with FDA to discuss path forward.","mRNA-1010 accepted for review in EU, Canada, Australia; earliest approval late 2026/early 2027.","Company reaffirms no change to 2026 financial guidance despite RTF."],"urls":{"canonical":"https://secwatch.observer/filing/0001682852-26-000012","json":"https://secwatch.observer/filing/0001682852-26-000012.json","markdown":"https://secwatch.observer/filing/0001682852-26-000012.md","text":"https://secwatch.observer/filing/0001682852-26-000012.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1682852/000168285226000012/0001682852-26-000012-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1682852/000168285226000012/mrna-20260203.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T03:20:08.162584+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"}