{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-250052","form_type":"8-K","ticker":"SNDX","cik":"0001395937","company_name":"Syndax Pharmaceuticals Inc","filed_at":"2025-10-24T23:59:59+00:00","discovered_at":"2026-05-14T18:02:39.298106+00:00","generated_at":"2026-05-17T02:19:16.268682+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Syndax receives FDA approval for Revuforj in NPM1-mutated R/R AML, second indication in <1 year","bullets":["FDA approved Revuforj (revumenib) for R/R AML with NPM1 mutation in patients aged ≥1 year.","CR+CRh rate of 23% (15/65); median time to response 2.8 months; median duration 4.5 months.","First and only FDA-approved menin inhibitor for both NPM1-m AML and KMT2A-r acute leukemia.","Included in NCCN Guidelines (Category 2A) for R/R NPM1m AML; commercial launch ongoing via SyndAccess.","Company to host conference call on Oct 24, 2025 at 2:30 p.m. ET."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-250052","json":"https://secwatch.observer/filing/0001193125-25-250052.json","markdown":"https://secwatch.observer/filing/0001193125-25-250052.md","text":"https://secwatch.observer/filing/0001193125-25-250052.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1395937/000119312525250052/0001193125-25-250052-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1395937/000119312525250052/sndx-20251024.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T02:19:16.268682+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"}