{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-218150","form_type":"8-K","ticker":"ALKS","cik":"0001520262","company_name":"Alkermes plc.","filed_at":"2026-05-12T11:07:58+00:00","discovered_at":"2026-05-12T11:10:00.362945+00:00","generated_at":"2026-05-12T11:10:51.364148+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"LUMRYZ meets all primary, key secondary endpoints in Phase 3 idiopathic hypersomnia study","bullets":["Primary endpoint ESS showed statistically significant improvement vs placebo (p<0.0001).","Key secondary endpoints PGI-C and IHSS also met with p<0.0001.","Safety profile consistent with known LUMRYZ safety; common AEs included nausea, headache.","Alkermes plans to file sNDA with FDA by end of 2026 for IH indication.","Settlement agreement restricts marketing of LUMRYZ for IH until March 1, 2028."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-218150","json":"https://secwatch.observer/filing/0001193125-26-218150.json","markdown":"https://secwatch.observer/filing/0001193125-26-218150.md","text":"https://secwatch.observer/filing/0001193125-26-218150.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1520262/000119312526218150/0001193125-26-218150-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1520262/000119312526218150/alks-20260512.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-12T11:10:51.364148+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"}