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Syndax Reports First Quarter 2025 Financial Results and Provides Business Update
SyndaxSyndax(US:SNDX) GlobeNewswire News Room·2025-05-05 20:01

Financial Performance - Syndax Pharmaceuticals reported $20.0 million in net revenue from Revuforj® (revumenib) in the first full quarter of its launch [1][4] - Niktimvo™ (axatilimab-csfr) generated $13.6 million in net revenue in its first partial quarter of launch, as reported by Incyte [1][8] - The company had cash, cash equivalents, and investments totaling $602.1 million as of March 31, 2025, which is expected to fund operations until profitability [1][7] Business Developments - The company submitted a supplemental New Drug Application (sNDA) for revumenib for the treatment of relapsed or refractory (R/R) mutant NPM1 acute myeloid leukemia (AML) [1][4] - A pivotal frontline trial of revumenib in combination with venetoclax and azacitidine for mNPM1 and KMT2Ar AML has been initiated [1][4] - Multiple ongoing trials are evaluating revumenib in various combinations and settings, including a Phase 1 trial showing a 100% overall response rate in newly diagnosed mNPM1 or KMT2Ar AML patients [4][5] Research and Development - Research and development expenses for the first quarter of 2025 increased to $61.6 million from $56.5 million in the prior year, driven by costs related to axatilimab and ongoing clinical trials [10] - Selling, general, and administrative expenses rose to $41.0 million from $23.0 million, primarily due to increased employee-related expenses and marketing efforts for Revuforj [11] - The company plans to initiate multiple trials of revumenib in combination with standard care regimens for newly diagnosed acute leukemia patients starting in the second half of 2025 [5][10] Future Outlook - For the second quarter of 2025, the company expects research and development expenses to be between $70 million and $75 million, with total operating expenses projected to be between $110 million and $115 million [13] - The company anticipates that its current cash position, along with expected product revenue, will enable it to reach profitability [14]