{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-001809","form_type":"8-K","ticker":"AGIO","cik":"0001439222","company_name":"AGIOS PHARMACEUTICALS, INC.","filed_at":"2025-01-06T23:59:59+00:00","discovered_at":"2026-05-14T18:03:03.635325+00:00","generated_at":"2026-05-28T10:28:21.617256+00:00","sec_items":["7.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"FDA adds liver injury warning to PYRUKYND label for PK deficiency","bullets":["FDA approved update to PYRUKYND USPI: liver injury observed in patients with another condition at higher doses.","New Warnings: obtain liver tests before initiation, monthly for first 6 months, interrupt if ALT >5x ULN.","All patients with liver injury discontinued PYRUKYND and improved upon discontinuation.","Adverse Reactions section updated to reflect hepatocellular injury in another condition."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-001809","json":"https://secwatch.observer/filing/0001193125-25-001809.json","markdown":"https://secwatch.observer/filing/0001193125-25-001809.md","text":"https://secwatch.observer/filing/0001193125-25-001809.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1439222/000119312525001809/0001193125-25-001809-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1439222/000119312525001809/d911895d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-28T10:28:21.617256+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"}