secwatch.observer — SEC 8-K summary
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Issuer:     Syndax Pharmaceuticals Inc (SNDX)
CIK:        0001395937
Form:       8-K
Filed at:   2024-05-08T23:59:59+00:00
Accession:  0000950170-24-055052
Event type: earnings
Sentiment:  positive
Materiality: 0.85
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Syndax Q1 net loss $72.4M ($0.85/shr); revumenib NDA & axatilimab BLA under Priority Review
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- Cash, equivalents and investments $522M; management believes sufficient for operations through 2026.
- Revumenib NDA for R/R KMT2Ar acute leukemia granted Priority Review; PDUFA date Sep 26, 2024.
- Axatilimab BLA for chronic GVHD granted Priority Review; PDUFA date Aug 28, 2024.
- Enrollment completed in AUGMENT-101 mNPM1 cohort; topline data expected 4Q24, potential sNDA 1H25.
- Appointed Steven Closter as Chief Commercial Officer; R&D expenses rose to $56.5M from $34.1M YoY.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1395937/000095017024055052/0000950170-24-055052-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1395937/000095017024055052/sndx-20240508.htm
  HTML page:      https://secwatch.observer/filing/0000950170-24-055052

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