{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-26-004246","form_type":"8-K","ticker":"NRXP","cik":"0001719406","company_name":"NRX Pharmaceuticals, Inc.","filed_at":"2026-02-17T23:59:59+00:00","discovered_at":"2026-05-14T18:02:35.995757+00:00","generated_at":"2026-05-16T02:28:24.094916+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"NRx Pharma announces FDA path to NDA for NRX-100 with broader TRD+suicidality indication","bullets":["FDA meeting provided clear path to submit NDA for NRX-100 under Fast Track; endpoints support full approval rather than Accelerated Approval.","Indication expanded to treatment-resistant depression with suicidality, targeting over 10 million TRD patients.","Real World Evidence from 65,000+ patient dataset to be used as confirmatory data; FDA to review analysis protocol.","NDA submission planned for Q2 2026; PDUFA date anticipated in 2026.","ANDA for generic ketamine remains under review with decision expected Summer 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-26-004246","json":"https://secwatch.observer/filing/0001437749-26-004246.json","markdown":"https://secwatch.observer/filing/0001437749-26-004246.md","text":"https://secwatch.observer/filing/0001437749-26-004246.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1719406/000143774926004246/0001437749-26-004246-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1719406/000143774926004246/nrxp20260216c_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T02:28:24.094916+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"}