Syndax Reports Second Quarter 2025 Financial Results and Provides Business Update

Core Insights - Syndax Pharmaceuticals reported strong financial results for Q2 2025, with significant growth in net revenues from its products Revuforj and Niktimvo, indicating a positive trajectory towards profitability [2][3][4]. Financial Performance - Revuforj (revumenib) generated $28.6 million in net revenue for Q2 2025, reflecting a 43% increase compared to Q1 2025 [4][8]. - Niktimvo (axatilimab-csfr) achieved $36.2 million in net revenue in its first full quarter post-launch, with Syndax recording $9.4 million in collaboration revenue from this product [3][11]. - Total revenue for Q2 2025 was reported at $38.0 million, combining Revuforj and Niktimvo revenues [8]. - The company had cash, cash equivalents, and investments totaling $517.9 million as of June 30, 2025, which is expected to support operations until profitability [7][14]. Product Updates - Revuforj is under Priority Review by the FDA for the treatment of relapsed or refractory mutant NPM1 acute myeloid leukemia (mNPM1 AML), with a PDUFA action date set for October 25, 2025 [4][17]. - Niktimvo is positioned as a treatment for chronic graft-versus-host disease (GVHD) and has shown rapid sales growth since its launch [11][21]. Clinical Trials and Research - Multiple ongoing clinical trials for revumenib are evaluating its efficacy in various acute leukemia settings, including pivotal Phase 3 trials [5][18]. - Recent data from the AUGMENT-101 trial indicated an overall response rate of 48% for patients with R/R mNPM1 AML, with a complete remission rate of 26% [4][5]. Expense Management - Research and development expenses increased to $62.2 million in Q2 2025, up from $48.7 million in the same period last year, primarily due to costs associated with revumenib trials [9]. - Selling, general, and administrative expenses rose to $43.8 million from $29.1 million year-over-year, reflecting increased marketing efforts for Revuforj [10]. Future Outlook - The company anticipates stable operating expenses over the next few years, which, combined with product revenues, is expected to lead to profitability [14]. - For Q3 2025, total expenses are projected to be between $95 million and $100 million, excluding non-cash stock compensation [13].