{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-24-124545","form_type":"8-K","ticker":"SNDX","cik":"0001395937","company_name":"Syndax Pharmaceuticals Inc","filed_at":"2024-11-12T23:59:59+00:00","discovered_at":"2026-05-14T18:03:08.333631+00:00","generated_at":"2026-05-30T01:41:32.106729+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Syndax reports positive pivotal Phase 2 results for revumenib in R/R mNPM1 AML; CR/CRh 23%","bullets":["Primary endpoint met: CR/CRh rate 23% (15/64; 95% CI 14%–36%; p=0.0014) in efficacy-evaluable adult patients.","ORR 47% (30/64); 75% had prior venetoclax; 36% received ≥3 prior lines of therapy.","Safety profile consistent; 5% discontinued due to TRAEs. Grade ≥3 TRAEs: QTc prolongation 21%, anemia 14%, febrile neutropenia 13%, DS 13%, platelet count decreased 11%.","sNDA filing for R/R mNPM1 AML expected in 1H25; FDA decision on KMT2Ar acute leukemias expected in 4Q24."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-24-124545","json":"https://secwatch.observer/filing/0000950170-24-124545.json","markdown":"https://secwatch.observer/filing/0000950170-24-124545.md","text":"https://secwatch.observer/filing/0000950170-24-124545.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1395937/000095017024124545/0000950170-24-124545-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1395937/000095017024124545/sndx-20241112.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-30T01:41:32.106729+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"}