{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-23-050922","form_type":"8-K","ticker":"SNDX","cik":"0001395937","company_name":"Syndax Pharmaceuticals Inc","filed_at":"2023-10-02T23:59:59+00:00","discovered_at":"2026-05-14T18:03:28.851867+00:00","generated_at":"2026-06-10T06:19:29.155291+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Syndax revumenib meets primary endpoint in pivotal AUGMENT-101 trial; CR/CRh 23% (p=0.0036)","bullets":["Primary endpoint met with CR/CRh 23% (13/57) in pooled KMT2Ar acute leukemia; p=0.0036.","65% overall response rate in KMT2Ar AML; 50% of transplanted patients received post-transplant revumenib.","Median duration of CR/CRh 6.4 months; 46% still in remission as of July 24, 2023.","Favorable safety: only 6% discontinued due to TRAEs; no discontinuations for DS or QTc prolongation.","Company to submit NDA for revumenib to FDA by year-end; funded into 2025."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-23-050922","json":"https://secwatch.observer/filing/0000950170-23-050922.json","markdown":"https://secwatch.observer/filing/0000950170-23-050922.md","text":"https://secwatch.observer/filing/0000950170-23-050922.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1395937/000095017023050922/0000950170-23-050922-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1395937/000095017023050922/sndx-20231002.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-10T06:19:29.155291+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"}