{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-26-030492","form_type":"8-K","ticker":"NRXP","cik":"0001719406","company_name":"NRX Pharmaceuticals, Inc.","filed_at":"2026-09-16T01:17:38+00:00","discovered_at":"2026-09-16T10:05:00.431974+00:00","generated_at":"2026-09-16T10:06:10.742219+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"FDA reclassifies NRx ketamine ANDA amendment from Major to Minor; goal date Nov 10, 2026","bullets":["FDA Office of Generic Drugs reclassified NRx's preservative-free ketamine ANDA amendment from Major to Minor.","GDUFA goal date revised to November 10, 2026; FDA cites amendment won't require substantial resource expenditure.","CEO Jonathan Javitt praised FDA speed in advancing approval of this strategic drug-shortage product.","Reclassification follows written FDA communication received September 15, 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-26-030492","json":"https://secwatch.observer/filing/0001437749-26-030492.json","markdown":"https://secwatch.observer/filing/0001437749-26-030492.md","text":"https://secwatch.observer/filing/0001437749-26-030492.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1719406/000143774926030492/0001437749-26-030492-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1719406/000143774926030492/nrxp20260915_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-09-16T10:06:10.742219+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"}