{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-23-069683","form_type":"8-K","ticker":"SNDX","cik":"0001395937","company_name":"Syndax Pharmaceuticals Inc","filed_at":"2023-12-12T23:59:59+00:00","discovered_at":"2026-05-14T18:03:28.852396+00:00","generated_at":"2026-06-07T14:05:18.286501+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 data for revumenib and axatilimab; BLAs/NDAs expected by year-end 2023","bullets":["Axatilimab AGAVE-201 trial met primary endpoint: 74% ORR at 0.3 mg/kg every two weeks in refractory chronic GVHD; BLA submission planned by year-end 2023.","Revumenib AUGMENT-101 pivotal trial met primary endpoint: CR/CRh rate 23% in R/R KMT2Ar acute leukemia; NDA submission planned by year-end 2023.","Combination data showed 100% CRc with revumenib + venetoclax/azacitidine in newly diagnosed mNPM1 or KMT2Ar AML (BEAT AML trial).","SAVE AML trial all-oral combination achieved 78% CRc in R/R AML; AUGMENT-102 pediatric trial achieved 33% CRc with fludarabine-cytarabine.","Median OS for revumenib monotherapy in AUGMENT-101 was 8.0 months; 68% of CRc responders achieved MRD negativity."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-23-069683","json":"https://secwatch.observer/filing/0000950170-23-069683.json","markdown":"https://secwatch.observer/filing/0000950170-23-069683.md","text":"https://secwatch.observer/filing/0000950170-23-069683.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1395937/000095017023069683/0000950170-23-069683-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1395937/000095017023069683/sndx-20231210.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-07T14:05:18.286501+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"}