{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-23-256178","form_type":"8-K","ticker":"AMLX","cik":"0001658551","company_name":"Amylyx Pharmaceuticals, Inc.","filed_at":"2023-10-13T23:59:59+00:00","discovered_at":"2026-05-14T18:03:29.967676+00:00","generated_at":"2026-06-10T00:03:36.917458+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"CHMP confirms negative opinion on Amylyx's AMX0035 for ALS in EU","bullets":["CHMP confirmed its initial negative opinion on Marketing Authorisation Application for AMX0035 (ALBRIOZA) for ALS.","Formal re-examination procedure concluded, upholding June 2023 initial negative opinion.","Decision applies to European Union marketing authorization for AMX0035."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-23-256178","json":"https://secwatch.observer/filing/0001193125-23-256178.json","markdown":"https://secwatch.observer/filing/0001193125-23-256178.md","text":"https://secwatch.observer/filing/0001193125-23-256178.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1658551/000119312523256178/0001193125-23-256178-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1658551/000119312523256178/d552411d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-10T00:03:36.917458+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"}