{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-24-238572","form_type":"8-K","ticker":"AMLX","cik":"0001658551","company_name":"Amylyx Pharmaceuticals, Inc.","filed_at":"2024-10-17T23:59:59+00:00","discovered_at":"2026-05-14T18:03:09.131640+00:00","generated_at":"2026-05-30T13:21:51.946637+00:00","sec_items":["8.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"HELIOS Phase 2: AMX0035 improves C-peptide AUC by +3.8 min*ng/mL at Week 24 in Wolfram syndrome","bullets":["Primary endpoint: C-peptide AUC improved at Week 24 (ITT +3.8 min*ng/mL; Per Protocol +20.2) and sustained through Week 48 (+36.7).","Glycemic control: HbA1c decreased (-0.09% at Week 24 to -0.35% at Week 36); time in target glucose range increased (+5.2% to +12.3%).","All 12 participants showed stability/improvement on CGIC and PGIC; no serious AEs related to AMX0035; diarrhea most common.","FDA and EU granted Orphan Drug Designation; company plans to meet FDA to discuss Phase 3, update in 2025."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-24-238572","json":"https://secwatch.observer/filing/0001193125-24-238572.json","markdown":"https://secwatch.observer/filing/0001193125-24-238572.md","text":"https://secwatch.observer/filing/0001193125-24-238572.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1658551/000119312524238572/0001193125-24-238572-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1658551/000119312524238572/d858945d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-30T13:21:51.946637+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"}