Syndax Q3 net loss $84.1M; revumenib PDUFA Dec 26; Niktimvo approved; $350M royalty funding

Syndax Pharmaceuticals Inc

2024-Q3 EPS reported -$2.63 revenue$16,000,000

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.

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