{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-23-173965","form_type":"8-K","ticker":"AMLX","cik":"0001658551","company_name":"Amylyx Pharmaceuticals, Inc.","filed_at":"2023-06-23T23:59:59+00:00","discovered_at":"2026-05-14T18:03:39.879402+00:00","generated_at":"2026-06-13T18:07:54.636911+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Amylyx receives CHMP negative opinion for AMX0035 ALS approval in EU; will seek re-examination","bullets":["CHMP adopted negative opinion on conditional marketing authorisation for AMX0035 (ALBRIOZA) for ALS in EU.","Company will request formal re-examination, a ~4-month process with new rapporteur and co-rapporteur.","Topline results from global Phase 3 PHOENIX study expected mid-2024.","ALS affects ~30,000 people in Europe; no new ALS innovations approved in EU in over 25 years.","AMX0035 is approved in the U.S. and with conditions in Canada based on CENTAUR trial data."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-23-173965","json":"https://secwatch.observer/filing/0001193125-23-173965.json","markdown":"https://secwatch.observer/filing/0001193125-23-173965.md","text":"https://secwatch.observer/filing/0001193125-23-173965.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1658551/000119312523173965/0001193125-23-173965-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1658551/000119312523173965/d470144d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-13T18:07:54.636911+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"}