{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-26-028992","form_type":"8-K","ticker":"MIRA","cik":"0001904286","company_name":"MIRA PHARMACEUTICALS, INC.","filed_at":"2026-06-17T12:00:39+00:00","discovered_at":"2026-06-17T12:05:00.428960+00:00","generated_at":"2026-06-17T12:11:11.336491+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"MIRA submits Phase 2a protocol to FDA for Ketamir-2 in CIPN","bullets":["Phase 2a protocol (Mira-002) for oral NMDA receptor modulator Ketamir-2 in chemotherapy-induced peripheral neuropathy.","Randomized, double-blind, placebo-controlled, three-period crossover trial with 300 mg and 600 mg doses.","No FDA-approved therapies exist for CIPN; study targets 30–40% of chemo patients affected.","Phase 1 showed clean safety: no serious AEs or dose-limiting toxicities in 56 volunteers.","Trial to run at a leading U.S. cancer center; FDA acknowledged receipt of submission."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-26-028992","json":"https://secwatch.observer/filing/0001493152-26-028992.json","markdown":"https://secwatch.observer/filing/0001493152-26-028992.md","text":"https://secwatch.observer/filing/0001493152-26-028992.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1904286/000149315226028992/0001493152-26-028992-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1904286/000149315226028992/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-17T12:11:11.336491+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"}