{"schema_version":"secwatch.filing_event.v1","accession":"0001558370-25-008525","form_type":"8-K","ticker":"HRMY","cik":"0001802665","company_name":"Harmony Biosciences Holdings, Inc.","filed_at":"2025-06-11T23:59:59+00:00","discovered_at":"2026-05-14T18:02:49.776289+00:00","generated_at":"2026-05-19T13:43:58.968353+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.5,"calibrated_materiality_score":0.5,"confidence":"high","headline":"Harmony Biosciences Presents Preclinical Data for BP1.15205 OX2R Agonist in Narcolepsy","bullets":["Data presented at SLEEP 2025 showed significant wake-promoting and cataplexy-suppressing effects in transgenic mouse model of narcolepsy type 1.","BP1.15205 demonstrated high potency (EC50=0.015 nM) and >600-fold selectivity over human OX1R.","No adverse events were observed in 3-month GLP toxicity study at doses up to 300 mg/kg/day.","First-in-human study planned for 2H 2025 with topline data anticipated in 2026.","IMPD application with EMA being completed; IND for BP1.15205 to be filed with FDA."],"urls":{"canonical":"https://secwatch.observer/filing/0001558370-25-008525","json":"https://secwatch.observer/filing/0001558370-25-008525.json","markdown":"https://secwatch.observer/filing/0001558370-25-008525.md","text":"https://secwatch.observer/filing/0001558370-25-008525.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1802665/000155837025008525/0001558370-25-008525-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1802665/000155837025008525/hrmy-20250611x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud","generated_at":"2026-05-19T13:43:58.968353+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"}