{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-23-033937","form_type":"8-K","ticker":"SNDX","cik":"0001395937","company_name":"Syndax Pharmaceuticals Inc","filed_at":"2023-07-24T23:59:59+00:00","discovered_at":"2026-05-14T18:03:33.778178+00:00","generated_at":"2026-06-13T04:07:54.736360+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/Incyte axatilimab hits primary endpoint in cGVHD trial; 74% ORR at 0.3 mg/kg dose","bullets":["AGAVE-201 met primary endpoint: ORR 74% (0.3 mg/kg Q2W), 67% (1.0 mg/kg), 50% (3.0 mg/kg Q4W).","At 0.3 mg/kg dose, 60% of responders maintained response at 12 months; median DOR not reached.","Patients had median 4 prior therapies; 54% with ≥4 organs involved; 45% lung involvement.","Syndax and Incyte intend to file BLA with FDA by year-end 2023.","Safety consistent with CSF-1R inhibition; 38% SAEs in 0.3 mg/kg group; 6.3% discontinued."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-23-033937","json":"https://secwatch.observer/filing/0000950170-23-033937.json","markdown":"https://secwatch.observer/filing/0000950170-23-033937.md","text":"https://secwatch.observer/filing/0000950170-23-033937.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1395937/000095017023033937/0000950170-23-033937-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1395937/000095017023033937/sndx-20230724.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-13T04:07:54.736360+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"}