{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-276161","form_type":"8-K","ticker":"ALKS","cik":"0001520262","company_name":"Alkermes plc.","filed_at":"2025-11-12T23:59:59+00:00","discovered_at":"2026-05-14T18:02:39.621073+00:00","generated_at":"2026-05-16T21:08:35.678057+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Alkermes' alixorexton meets dual primary endpoints in Phase 2 narcolepsy type 2 study","bullets":["Alixorexton (10, 14, 18 mg) showed statistically significant improvements vs placebo on MWT and ESS at week 8.","14 mg and 18 mg doses achieved statistical significance on MWT (p<0.05); 18 mg dose on ESS (p<0.05).","Drug was generally well tolerated; most common TEAEs were pollakiuria, insomnia, urinary urgency, dizziness, headache.","No serious TEAEs, no safety signals in hepatic, renal, vitals, ECGs, or ophthalmic exams.","Phase 3 program for narcolepsy type 1 and type 2 expected to initiate in Q1 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-276161","json":"https://secwatch.observer/filing/0001193125-25-276161.json","markdown":"https://secwatch.observer/filing/0001193125-25-276161.md","text":"https://secwatch.observer/filing/0001193125-25-276161.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1520262/000119312525276161/0001193125-25-276161-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1520262/000119312525276161/alks-20251112.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T21:08:35.678057+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"}