{"schema_version":"secwatch.filing_event.v1","accession":"0001558370-24-013103","form_type":"8-K","ticker":"HRMY","cik":"0001802665","company_name":"Harmony Biosciences Holdings, Inc.","filed_at":"2024-10-01T23:59:59+00:00","discovered_at":"2026-05-14T18:03:09.691145+00:00","generated_at":"2026-05-30T23:40:39.235192+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Harmony Biosciences highlights best-in-class orexin-2 agonist, $3B revenue goal at Investor Day","bullets":["BP1.15205 orexin-2 agonist shows highest potency vs. all publicly disclosed competitors, potential best-in-class.","Pitolisant in IH: mean ESS improvement ~9 points beyond 1 year; majority achieve normal wakefulness; sNDA on track Q4 2024.","Pitolisant-HD safety data up to 5x highest WAKIX dose; target PDUFA 2028; market research anticipates high uptake.","Fragile X (ZYN-002): 40% median improvement in social avoidance (p=0.027) in methylated patients; Phase 3 topline mid-2025.","EPX-100 in Dravet syndrome shows favorable safety vs approved drugs; topline 2026; Phase 3 LGS starts 2024."],"urls":{"canonical":"https://secwatch.observer/filing/0001558370-24-013103","json":"https://secwatch.observer/filing/0001558370-24-013103.json","markdown":"https://secwatch.observer/filing/0001558370-24-013103.md","text":"https://secwatch.observer/filing/0001558370-24-013103.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1802665/000155837024013103/0001558370-24-013103-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1802665/000155837024013103/hrmy-20241001x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-30T23:40:39.235192+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"}