{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-24-062878","form_type":"8-K","ticker":"AMLX","cik":"0001658551","company_name":"Amylyx Pharmaceuticals, Inc.","filed_at":"2024-03-08T23:59:59+00:00","discovered_at":"2026-05-14T18:03:25.005216+00:00","generated_at":"2026-06-05T00:34:28.293834+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"negative","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"Amylyx Phase 3 ALS trial misses primary endpoint; may withdraw RELYVRIO","bullets":["PHOENIX trial: no significant difference on ALSFRS-R at Week 48 (p=0.667); secondary endpoints also missed.","Company may voluntarily withdraw RELYVRIO/ALBRIOZA from market; will decide within 8 weeks after regulatory discussions.","Promotion paused immediately; drug and patient support remain available for now.","Study enrolled 664 adults; safety profile consistent, no new signals.","Phase 3 ORION in PSP and Phase 2 HELIOS in Wolfram syndrome continue as planned."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-24-062878","json":"https://secwatch.observer/filing/0001193125-24-062878.json","markdown":"https://secwatch.observer/filing/0001193125-24-062878.md","text":"https://secwatch.observer/filing/0001193125-24-062878.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1658551/000119312524062878/0001193125-24-062878-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1658551/000119312524062878/d787565d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-05T00:34:28.293834+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"}