Syndax Reports Third Quarter 2025 Financial Results and Provides Business Update

Core Insights - Syndax Pharmaceuticals reported total revenue of $45.9 million for Q3 2025, marking a 21% increase compared to Q2 2025 [1] - The company achieved FDA approval for Revuforj on October 24, 2025, for the treatment of relapsed or refractory NPM1m acute myeloid leukemia (AML) [1][5] - Syndax has $456.1 million in cash and investments, which is expected to fund the company to profitability [1][8] Financial Performance - Revuforj generated $32.0 million in net revenue for Q3 2025, a 12% increase from Q2 2025, with total prescriptions rising by 25% [4][5] - Niktimvo reported $45.8 million in net revenue, with Syndax recording $13.9 million in collaboration revenue from this product [9][11] - The net loss attributable to common stockholders for Q3 2025 was $60.7 million, or $0.70 per share, an improvement from a net loss of $84.1 million, or $0.98 per share, in the same period last year [13][29] Business Highlights - Strong demand for Revuforj and Niktimvo resulted in over $75 million in combined net sales for the quarter [2] - Revuforj was included in the NCCN Guidelines for R/R NPM1m AML as a category 2A recommended treatment option [5] - The company is advancing multiple clinical trials for Revuforj and Niktimvo, targeting various indications and patient populations [10][18] Research and Development - Research and development expenses decreased to $56.3 million in Q3 2025 from $71.0 million in the prior year, primarily due to the absence of a milestone payment related to Niktimvo's approval [11] - Selling, general, and administrative expenses increased to $44.9 million from $31.1 million, driven by higher commercial costs associated with the launches of Revuforj and Niktimvo [12] Future Outlook - The company expects total operating expenses for 2025 to be between $380 million and $385 million, excluding an estimated $45 million in non-cash stock compensation [14] - Syndax anticipates that its current cash reserves, combined with expected product revenue, will enable it to reach profitability [15]