{"schema_version":"secwatch.filing_event.v1","accession":"0001641172-25-021155","form_type":"8-K","ticker":"MIRA","cik":"0001904286","company_name":"MIRA PHARMACEUTICALS, INC.","filed_at":"2025-07-28T23:59:59+00:00","discovered_at":"2026-05-14T18:02:45.564230+00:00","generated_at":"2026-05-18T00:26:47.103670+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"MIRA Pharma receives FDA IND clearance for Ketamir-2, advancing neuropathic pain program","bullets":["FDA cleared IND for Ketamir-2, an oral NMDA antagonist for neuropathic pain, enabling U.S. clinical trials.","Preclinical head-to-head data showed superior efficacy to gabapentin and pregabalin with no ketamine-related neurotoxicity.","Phase 1 single ascending dose portion nearing completion; U.S. Phase 2a efficacy trial planned for Q4 2025.","Acquisition of SKNY Pharmaceuticals on track; SKNY-1 shows efficacy in obesity and nicotine craving models.","MIRA-55 oral cannabinoid analog demonstrated comparable efficacy to morphine in inflammatory pain models."],"urls":{"canonical":"https://secwatch.observer/filing/0001641172-25-021155","json":"https://secwatch.observer/filing/0001641172-25-021155.json","markdown":"https://secwatch.observer/filing/0001641172-25-021155.md","text":"https://secwatch.observer/filing/0001641172-25-021155.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1904286/000164117225021155/0001641172-25-021155-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1904286/000164117225021155/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-18T00:26:47.103670+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"}