{"schema_version":"secwatch.filing_event.v1","accession":"0001558370-23-004860","form_type":"8-K","ticker":"HRMY","cik":"0001802665","company_name":"Harmony Biosciences Holdings, Inc.","filed_at":"2023-03-29T23:59:59+00:00","discovered_at":"2026-05-14T18:03:46.636935+00:00","generated_at":"2026-06-17T10:48:49.773290+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Harmony Biosciences accelerates Phase 3 INTUNE enrollment; topline data expected Q4 2023","bullets":["Enrollment completion expected Q2 2023, just over one year from trial initiation.","Topline data anticipated in Q4 2023.","Pre-specified interim sample size analysis allowed study to continue with original planned sample size.","Phase 3 INTUNE study: double-blind, placebo-controlled, randomized withdrawal in ~200 IH patients at ~60 U.S. sites.","Pitolisant (WAKIX) is approved for narcolepsy but not yet for idiopathic hypersomnia."],"urls":{"canonical":"https://secwatch.observer/filing/0001558370-23-004860","json":"https://secwatch.observer/filing/0001558370-23-004860.json","markdown":"https://secwatch.observer/filing/0001558370-23-004860.md","text":"https://secwatch.observer/filing/0001558370-23-004860.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1802665/000155837023004860/0001558370-23-004860-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1802665/000155837023004860/hrmy-20230329x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-17T10:48:49.773290+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"}