earnings
confidence high
sentiment positive
materiality 0.80
Syndax reports Q3 net loss $0.73/sh, initiates revumenib NDA in R/R KMT2Ar leukemia
Syndax Pharmaceuticals Inc
2023-Q3 EPS reported
-$1.97
- Net loss $51.1M ($0.73/sh) vs $35.4M ($0.58/sh) YoY; cash $379.3M as of Sep 30, 2023.
- NDA submission initiated for revumenib in R/R KMT2Ar acute leukemia under FDA RTOR; completion expected by year-end 2023.
- Final Phase 1 mNPM1 data: 36% CR/CRh (5/14); 100% of CR/CRh patients MRD-negative; responses durable >22 months.
- Pivotal AUGMENT-101 met primary endpoint: 23% CR/CRh in KMT2Ar acute leukemia; median duration 6.4 months.
- Full-year 2023 expense guidance reduced: R&D now $160-165M (prev $160-175M); total OpEx $225-230M (prev $225-240M).