{"schema_version":"secwatch.filing_event.v1","accession":"0001558370-23-016428","form_type":"8-K","ticker":"HRMY","cik":"0001802665","company_name":"Harmony Biosciences Holdings, Inc.","filed_at":"2023-10-13T23:59:59+00:00","discovered_at":"2026-05-14T18:03:30.527992+00:00","generated_at":"2026-06-10T00:07:44.755419+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Phase 3 INTUNE study for pitolisant in idiopathic hypersomnia misses primary endpoint","bullets":["Primary endpoint (ESS change) did not reach statistical significance between pitolisant and placebo in the randomized withdrawal phase.","83% of patients completing open-label phase responded with average ESS improvement of 9.4 points; 88% continued into long-term extension.","Positive trends favoring pitolisant observed on IHSS (approached significance) and Sleep Inertia Questionnaire.","Safety profile consistent with established pitolisant profile; no new safety signals.","Company plans to discuss full data with FDA to determine next steps for pitolisant in IH."],"urls":{"canonical":"https://secwatch.observer/filing/0001558370-23-016428","json":"https://secwatch.observer/filing/0001558370-23-016428.json","markdown":"https://secwatch.observer/filing/0001558370-23-016428.md","text":"https://secwatch.observer/filing/0001558370-23-016428.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1802665/000155837023016428/0001558370-23-016428-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1802665/000155837023016428/hrmy-20231013x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-10T00:07:44.755419+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"}