{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-24-127708","form_type":"8-K","ticker":"SNDX","cik":"0001395937","company_name":"Syndax Pharmaceuticals Inc","filed_at":"2024-11-18T23:59:59+00:00","discovered_at":"2026-05-14T18:03:08.333846+00:00","generated_at":"2026-05-29T22:57:10.868483+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.95,"calibrated_materiality_score":0.95,"confidence":"high","headline":"Syndax receives FDA approval for Revuforj as first menin inhibitor for KMT2A-translocated acute leukemia","bullets":["FDA approved Revuforj for R/R acute leukemia with KMT2A translocation in patients aged 1+ years.","Efficacy: CR+CRh rate 21% (22/104), median duration 6.4 months, median time to remission 1.9 months.","Safety: common AEs include hemorrhage, febrile neutropenia, differentiation syndrome; 12% discontinued.","Commercial launch of 110/160 mg tablets expected Nov 2024; 25 mg tablets in early 2025.","SyndAccess patient support program launched; oral solution available via expanded access for patients <40 kg."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-24-127708","json":"https://secwatch.observer/filing/0000950170-24-127708.json","markdown":"https://secwatch.observer/filing/0000950170-24-127708.md","text":"https://secwatch.observer/filing/0000950170-24-127708.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1395937/000095017024127708/0000950170-24-127708-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1395937/000095017024127708/sndx-20241115.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-29T22:57:10.868483+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"}