{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-22-254838","form_type":"8-K","ticker":"AMLX","cik":"0001658551","company_name":"Amylyx Pharmaceuticals, Inc.","filed_at":"2022-09-30T23:59:59+00:00","discovered_at":"2026-05-14T18:03:56.561459+00:00","generated_at":"2026-06-23T06:23:11.726603+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"FDA approves Amylyx's RELYVRIO for ALS; Phase 2 trial showed slowed physical decline","bullets":["FDA approved RELYVRIO (AMX0035) for adults with ALS based on Phase 2 CENTAUR trial in 137 participants that met primary efficacy endpoint.","RELYVRIO significantly slowed loss of physical function vs placebo; can be used as monotherapy or with existing ALS treatments.","Amylyx priced RELYVRIO below the latest FDA-approved ALS product; expects specialty pharmacies to start filling prescriptions within 4-6 weeks.","Most common adverse events (>=15% and >=5% over placebo) were diarrhea, abdominal pain, nausea, and upper respiratory tract infection.","Management to host investor conference call Sept 30 at 8:00 AM ET to discuss approval and commercial plans."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-22-254838","json":"https://secwatch.observer/filing/0001193125-22-254838.json","markdown":"https://secwatch.observer/filing/0001193125-22-254838.md","text":"https://secwatch.observer/filing/0001193125-22-254838.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1658551/000119312522254838/0001193125-22-254838-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1658551/000119312522254838/d379888d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-23T06:23:11.726603+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"}