{"schema_version":"secwatch.filing_event.v1","accession":"0001439222-26-000018","form_type":"8-K","ticker":"AGIO","cik":"0001439222","company_name":"AGIOS PHARMACEUTICALS, INC.","filed_at":"2026-01-12T23:59:59+00:00","discovered_at":"2026-05-14T18:02:35.091303+00:00","generated_at":"2026-05-16T10:50:07.879905+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Agios outlines 2026 milestones: AQVESME launch in thalassemia, potential sNDA for sickle cell disease","bullets":["AQVESME (mitapivat) U.S. approval in thalassemia Dec 2025; commercial launch underway, product available late Jan 2026.","Pre-sNDA meeting with FDA for mitapivat in sickle cell disease expected Q1 2026; U.S. submission to follow.","Pipeline: tebapivat Phase 2 sickle cell topline H2 2026; Phase 2b LR-MDS topline H1 2026.","AG-236 (siRNA for PV) Phase 1 healthy volunteer topline H1 2026; AG-181 Phase 1b PKU trial init H1 2026.","Target >$1B peak global sales from existing thalassemia and PK deficiency commercial presence."],"urls":{"canonical":"https://secwatch.observer/filing/0001439222-26-000018","json":"https://secwatch.observer/filing/0001439222-26-000018.json","markdown":"https://secwatch.observer/filing/0001439222-26-000018.md","text":"https://secwatch.observer/filing/0001439222-26-000018.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1439222/000143922226000018/0001439222-26-000018-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1439222/000143922226000018/agio-20260112.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T10:50:07.879905+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"}