secwatch.observer — SEC 8-K summary
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Issuer:     Syndax Pharmaceuticals Inc (SNDX)
CIK:        0001395937
Form:       8-K
Filed at:   2024-11-05T23:59:59+00:00
Accession:  0000950170-24-121437
Event type: earnings
Sentiment:  neutral
Materiality: 0.80
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Syndax Q3 net loss $84.1M; revumenib PDUFA Dec 26; Niktimvo approved; $350M royalty funding
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- Net loss $84.1M ($0.98/share) vs $51.1M ($0.73) in Q3 2023; R&D $71.0M, SG&A $31.1M.
- Revumenib NDA under FDA RTOR with PDUFA Dec 26, 2024; topline mNPM1 AML data expected Q4 2024, potential sNDA 1H25.
- Niktimvo (axatilimab) approved by FDA for chronic GVHD after ≥2 prior lines; launch early Q1 2025.
- $350M royalty funding agreement with Royalty Pharma (13.8% royalty on U.S. Niktimvo sales) expected to fund to profitability.
- Full-year 2024 guidance: R&D $245-250M, total op. exp. $365-370M; cash $399.6M as of Sep 30.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1395937/000095017024121437/0000950170-24-121437-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1395937/000095017024121437/sndx-20241105.htm
  HTML page:      https://secwatch.observer/filing/0000950170-24-121437

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