{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-25-029907","form_type":"8-K","ticker":"NRXP","cik":"0001719406","company_name":"NRX Pharmaceuticals, Inc.","filed_at":"2025-09-26T23:59:59+00:00","discovered_at":"2026-05-14T18:02:44.768978+00:00","generated_at":"2026-05-17T05:34:31.452729+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"FDA grants Suitability Petition for NRx's preservative-free ketamine, enabling ANDA re-filing","bullets":["FDA approved Suitability Petition for proposed strength of NRx's single-patient, preservative-free ketamine (KETAFREE™).","Currently marketed ketamine uses multi-dose vials with toxic preservative Benzethonium Chloride; KETAFREE™ is preservative-free.","Suitability Petition grant enables immediate re-filing of Abbreviated New Drug Application (ANDA) for KETAFREE™.","NRx estimates total ketamine market at $750M; product aligns with FDA/HHS policy on removing toxic preservatives.","NRx CEO noted rapid FDA response after company attended listening session with FDA Commissioner."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-25-029907","json":"https://secwatch.observer/filing/0001437749-25-029907.json","markdown":"https://secwatch.observer/filing/0001437749-25-029907.md","text":"https://secwatch.observer/filing/0001437749-25-029907.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1719406/000143774925029907/0001437749-25-029907-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1719406/000143774925029907/nrxp20250926_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T05:34:31.452729+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"}