{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-25-008977","form_type":"8-K","ticker":"MIRA","cik":"0001904286","company_name":"MIRA PHARMACEUTICALS, INC.","filed_at":"2025-03-04T23:59:59+00:00","discovered_at":"2026-05-14T18:03:05.549204+00:00","generated_at":"2026-05-25T15:53:32.148924+00:00","sec_items":["8.01"],"event_type":"other_material","sentiment":"neutral","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"MIRA Pharma receives Israeli MoH approval to start Phase 1 trial for Ketamir-2 in neuropathic pain","bullets":["Approval from Israeli Ministry of Health and IRB to initiate Phase 1 trial for Ketamir-2, an oral ketamine analog.","Randomized, double-blind, placebo-controlled study evaluating safety, tolerability, and PK in healthy volunteers at Hadassah Medical Center.","Subject recruitment begins Q1 2025; Phase 1 expected to conclude Q4 2025, followed by Phase 2a in neuropathic pain patients by year-end.","Awaiting neurotoxicity study results from FDA, expected Q2 2025, to enable IND and U.S. patient dosing."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-25-008977","json":"https://secwatch.observer/filing/0001493152-25-008977.json","markdown":"https://secwatch.observer/filing/0001493152-25-008977.md","text":"https://secwatch.observer/filing/0001493152-25-008977.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1904286/000149315225008977/0001493152-25-008977-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1904286/000149315225008977/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-25T15:53:32.148924+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"}