{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-25-014393","form_type":"8-K","ticker":"MIRA","cik":"0001904286","company_name":"MIRA PHARMACEUTICALS, INC.","filed_at":"2025-09-22T23:59:59+00:00","discovered_at":"2026-05-14T18:02:45.565476+00:00","generated_at":"2026-05-17T06:00:42.623480+00:00","sec_items":["8.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"MIRA Pharma Phase 1 SAD of Ketamir-2 safe, well tolerated; positive PK","bullets":["Phase 1 SAD study in 32 healthy volunteers (50-600 mg doses) showed no severe or serious adverse events.","Dose-proportional exposure (Cmax, AUC); median Tmax 1-2 h; half-life 2-5 h; metabolite nor-Ketamir half-life 6.5-8.5 h.","Company to initiate MAD portion of Phase 1, followed by Phase 2a trial in neuropathic pain patients.","DEA concluded Ketamir-2 is not a controlled substance under the Controlled Substances Act."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-25-014393","json":"https://secwatch.observer/filing/0001493152-25-014393.json","markdown":"https://secwatch.observer/filing/0001493152-25-014393.md","text":"https://secwatch.observer/filing/0001493152-25-014393.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1904286/000149315225014393/0001493152-25-014393-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1904286/000149315225014393/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T06:00:42.623480+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"}