secwatch.observer — SEC 8-K summary
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Issuer:     Syndax Pharmaceuticals Inc (SNDX)
CIK:        0001395937
Form:       8-K
Filed at:   2023-07-24T23:59:59+00:00
Accession:  0000950170-23-033937
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Syndax/Incyte axatilimab hits primary endpoint in cGVHD trial; 74% ORR at 0.3 mg/kg dose
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1395937/000095017023033937/0000950170-23-033937-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1395937/000095017023033937/sndx-20230724.htm
  HTML page:      https://secwatch.observer/filing/0000950170-23-033937

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer