{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-270280","form_type":"8-K","ticker":"ALKS","cik":"0001520262","company_name":"Alkermes plc.","filed_at":"2026-06-15T11:09:44+00:00","discovered_at":"2026-06-15T11:15:00.355197+00:00","generated_at":"2026-06-15T11:15:30.998863+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Alkermes announces orphan drug designations for alixorexton in US for IH and EU for narcolepsy","bullets":["FDA grants orphan drug designation to alixorexton for idiopathic hypersomnia.","European Commission grants orphan drug designation to alixorexton for narcolepsy.","Alixorexton is an oral OX2R agonist in phase 3 for narcolepsy and phase 2 for IH.","ODD provides market exclusivity (7 yrs US, 10 yrs EU) if approved.","Alixorexton previously received FDA Breakthrough Therapy for NT1."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-270280","json":"https://secwatch.observer/filing/0001193125-26-270280.json","markdown":"https://secwatch.observer/filing/0001193125-26-270280.md","text":"https://secwatch.observer/filing/0001193125-26-270280.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1520262/000119312526270280/0001193125-26-270280-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1520262/000119312526270280/alks-20260615.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-15T11:15:30.998863+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"}