secwatch.observer — SEC 8-K summary
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Issuer:     Syndax Pharmaceuticals Inc (SNDX)
CIK:        0001395937
Form:       8-K
Filed at:   2024-11-18T23:59:59+00:00
Accession:  0000950170-24-127708
Event type: regulatory
Sentiment:  positive
Materiality: 0.95
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Syndax receives FDA approval for Revuforj as first menin inhibitor for KMT2A-translocated acute leukemia
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- FDA approved Revuforj for R/R acute leukemia with KMT2A translocation in patients aged 1+ years.
- Efficacy: CR+CRh rate 21% (22/104), median duration 6.4 months, median time to remission 1.9 months.
- Safety: common AEs include hemorrhage, febrile neutropenia, differentiation syndrome; 12% discontinued.
- Commercial launch of 110/160 mg tablets expected Nov 2024; 25 mg tablets in early 2025.
- SyndAccess patient support program launched; oral solution available via expanded access for patients <40 kg.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1395937/000095017024127708/0000950170-24-127708-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1395937/000095017024127708/sndx-20241115.htm
  HTML page:      https://secwatch.observer/filing/0000950170-24-127708

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