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]

Core Insights - Syndax Pharmaceuticals will host an in-person investor event on December 8, 2025, at 7:00 a.m. ET during the ASH Annual Meeting to discuss data updates from its Revuforj and Niktimvo programs [1] Company Overview - Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company focused on innovative cancer therapies, with key products including Revuforj (revumenib), an FDA-approved menin inhibitor, and Niktimvo™ (axatilimab-csfr), an FDA-approved monoclonal antibody targeting the CSF-1 receptor [3] - The company is committed to advancing its pipeline and is conducting several clinical trials across various treatment stages [3]

Core Insights - Syndax Pharmaceuticals announced the acceptance of 23 abstracts, including six oral presentations, for the 67th American Society of Hematology (ASH) Annual Meeting, highlighting the company's advancements in menin inhibition and CSF-1R inhibition [1][2] Revumenib - Revumenib abstracts demonstrate promising results across various acute leukemia subtypes, including relapsed/refractory (R/R) settings and post-HSCT scenarios [1][2] - New frontline datasets will showcase the tolerability of Revumenib in combination with standard therapies, achieving high rates of complete remission and minimal residual disease (MRD) negativity [2][5] - The first real-world evidence for a menin inhibitor will be presented, along with a retrospective review of its use in post-transplant settings [2][5] - Key presentations include a Phase 2 study of Revumenib combined with venetoclax and decitabine/cedazuridine in newly diagnosed acute myeloid leukemia (AML) [7] - Additional presentations will cover efficacy and safety by leukemia type in patients with R/R KMT2Ar acute leukemia [7] Axatilimab - Axatilimab abstracts will focus on its long-term benefits in R/R chronic graft-versus-host disease (GVHD) and its tolerability when combined with ruxolitinib in newly diagnosed chronic GVHD [1][2] - An oral presentation will detail the safety and feasibility of transitioning dosing from 0.3 mg/kg every 2 weeks to 0.6 mg/kg every 4 weeks in the pivotal Phase 2 AGAVE-201 trial [4][10] - Presentations will also include interim safety analyses from a Phase 2 trial of axatilimab combined with ruxolitinib in newly diagnosed chronic GVHD [8][10] Company Overview - Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company focused on innovative cancer therapies, with a pipeline that includes Revuforj (revumenib) and Niktimvo (axatilimab) [44] - The company is committed to advancing its clinical trials across various treatment landscapes, aiming to unlock the full potential of its product candidates [44]

Core Insights - Syndax Pharmaceuticals will report its third quarter 2025 financial results and provide a business update on November 3, 2025 [1] - A conference call and live audio webcast will be hosted by Syndax's management at 4:30 p.m. ET on the same day [1] Company Overview - Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company focused on innovative cancer therapies [3] - The company's pipeline includes Revuforj (revumenib), an FDA-approved menin inhibitor, and Niktimvo™ (axatilimab-csfr), an FDA-approved monoclonal antibody targeting the CSF-1 receptor [3] - Syndax is committed to advancing cancer care and is conducting several clinical trials across various treatment stages [3]

FDA Approval and Indication - Revuforj获得FDA批准，用于治疗复发或难治性（R/R）急性髓系白血病（AML），该白血病在1岁及以上的成人和儿童患者中具有易感的NPM1突变，且没有令人满意的替代治疗方案[8] - Revuforj还被批准用于治疗具有KMT2A易位的R/R急性白血病，适用于1岁及以上的成人和儿童患者[11] - Revuforj是首个也是唯一获批用于多种急性白血病亚型的menin抑制剂，适用于成人和儿童[8, 12] Clinical Data and Efficacy - AUGMENT-101关键试验数据显示，Revuforj在R/R NPM1m AML患者中，完全缓解（CR）加上伴有部分血液学恢复的CR（CRh）率为23%[22] - AUGMENT-101试验的中位CR/CRh时间为2.8个月，CR/CRh的中位持续时间为4.5个月[22] - AUGMENT-101试验中，47%的患者达到总缓解率[22] - AUGMENT-101试验的CR/CRh患者中，63%达到MRD阴性[22] - 在缓解者亚组分析中观察到23个月的中位总生存期[22] Market Opportunity and Commercial Strategy - Revuforj在美国R/R急性白血病市场拥有超过20亿美元的市场机会[28] - Revuforj在R/R和一线治疗环境中拥有超过50亿美元的美国市场机会[9, 29] - Revuforj有望成为最大的靶向AML疗法，在可寻址的AML人群中占据40-45%的份额[30, 31] - 通过2025年第二季度，Revuforj已实现65%的一级/二级账户渗透率[34] - Revuforj已列入NCCN指南，用于R/R NPM1m AML和KMT2Ar急性白血病[12, 26]

Core Insights - Syndax Pharmaceuticals has received FDA approval for Revuforj (revumenib) as the first and only therapy for both relapsed or refractory (R/R) acute myeloid leukemia (AML) with an NPM1 mutation and R/R acute leukemia with a KMT2A translocation, marking a significant advancement in treatment options for these aggressive blood cancers [2][3][4] Company Developments - Revuforj is now approved for use in adult and pediatric patients aged one year and older who have no satisfactory alternative treatment options, expanding its indication from a previous approval for R/R acute leukemia with a KMT2A translocation [2][11] - The approval is based on data from the Phase 2 portion of the AUGMENT-101 trial, which demonstrated a complete remission (CR) plus CR with partial hematological recovery (CRh) rate of 23% among patients with R/R NPM1 mutated AML [3][4] - The median time to CR or CRh response was reported at 2.8 months, with a median duration of 4.5 months [3] Industry Impact - The inclusion of Revuforj in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines as a category 2A recommended treatment option for R/R NPM1 mutated AML and R/R acute leukemia with a KMT2A rearrangement underscores its significance in the oncology landscape [5][6] - The approval of Revuforj is expected to set a new standard of care for patients with these difficult-to-treat blood cancers, as highlighted by experts in the field [4][5] - The company is committed to supporting patient access through its SyndAccess program, which provides personalized support and financial assistance for eligible patients [8]

Core Insights - Syndax Pharmaceuticals announced that revumenib has been included as a category 2A recommendation in the NCCN Guidelines for relapsed or refractory acute myeloid leukemia (AML) with an NPM1 mutation, highlighting the drug's clinical significance [1][2] - The company has submitted a supplemental New Drug Application (sNDA) for revumenib, which has been granted Priority Review by the FDA, with a target action date of October 25, 2025 [2][6] Company Overview - Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company focused on innovative cancer therapies, with revumenib being a first-in-class menin inhibitor approved for certain types of acute leukemia [5][23] - The company is actively conducting multiple clinical trials to explore revumenib's efficacy in various treatment settings, including combinations with standard therapies for newly diagnosed patients [7][24] Industry Context - The NCCN is a not-for-profit alliance of 33 leading cancer centers that develops clinical practice guidelines to inform treatment decisions for healthcare stakeholders [3] - Mutant NPM1 (mNPM1) AML is a prevalent genetic alteration in AML, affecting approximately 30% of adult patients, and is associated with a poor prognosis and high relapse rates [4]

Core Insights - Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company focused on innovative cancer therapies [2] - The company has FDA-approved products in its pipeline, including Revuforj (revumenib) and Niktimvo™ (axatilimab-csfr) [2] - Syndax is actively participating in upcoming investor conferences to engage with stakeholders [1][3] Company Overview - Syndax Pharmaceuticals is dedicated to advancing cancer care through its innovative therapies [2] - The company is conducting several clinical trials to maximize the potential of its product pipeline [2] Upcoming Events - Syndax's CEO and management team will participate in Citi's 2025 BioPharma Back to School Conference on September 2, 2025 [3] - The company will also present at H.C. Wainwright's 27th Annual Global Investment Conference on September 8, 2025 [3]

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].

Company Overview - Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company focused on advancing innovative cancer therapies [3] - The company's pipeline includes FDA-approved therapies such as Revuforj (revumenib), a menin inhibitor, and Niktimvo™ (axatilimab-csfr), a monoclonal antibody targeting the CSF-1 receptor [3] Upcoming Financial Results - Syndax Pharmaceuticals will report its second quarter 2025 financial results and provide a business update on August 4, 2025 [1] - A conference call and live audio webcast will be hosted by the management at 4:30 p.m. ET on the same day [1] Accessing the Conference Call - The live audio webcast and accompanying slides can be accessed through the Events & Presentations page on the company's website [2] - Domestic and international dial-in numbers are provided for the conference call, with a specific Conference ID: Syndax2Q25 [2] - A replay of the conference call will be available approximately 24 hours after the event and will remain accessible for 90 days [2]