{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-25-097323","form_type":"8-K","ticker":"ALKS","cik":"0001520262","company_name":"Alkermes plc.","filed_at":"2025-07-21T23:59:59+00:00","discovered_at":"2026-05-14T18:02:44.207173+00:00","generated_at":"2026-05-18T05:02:27.004758+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Alkermes reports positive phase 2 results for alixorexton in narcolepsy type 1; primary endpoint met","bullets":["Alixorexton met primary endpoint: statistically significant and dose-dependent improvements in wakefulness (MWT) vs placebo (p<0.0001 at all doses).","Key secondary: ESS improved significantly at all doses (p<0.0001); weekly cataplexy rates numerically improved, significant at 6 mg (p=0.005).","Exploratory endpoints: alixorexton improved disease severity (NSS), cognition (BC-CCI), and fatigue (PROMIS-Fatigue) at all doses (p<0.01).","Alixorexton was generally well tolerated; no serious AEs; >95% of patients entered open-label extension.","Data support rapid initiation of global phase 3 program in NT1; detailed results at World Sleep Congress Sept 2025."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-25-097323","json":"https://secwatch.observer/filing/0000950170-25-097323.json","markdown":"https://secwatch.observer/filing/0000950170-25-097323.md","text":"https://secwatch.observer/filing/0000950170-25-097323.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1520262/000095017025097323/0000950170-25-097323-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1520262/000095017025097323/alks-20250721.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-18T05:02:27.004758+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"}