Financial Performance & Growth - Syndax reported net product revenue of $32 million in 3Q25[3], representing a 25% quarter-over-quarter (q/q) growth in total prescriptions (TRx)[3, 4] - Collaboration revenue reached $139 million in 3Q25, with $13.9 million attributed to Syndax[3] - Niktimvo net revenue was $45.8 million in 3Q25, reflecting a 27% q/q growth[13] and collaboration revenue to Syndax was $13.9 million, up 48% q/q[13] - As of September 30, 2025, Syndax had $456 million in cash and equivalents[39] Revuforj Highlights - Revuforj achieved approximately 2,200 cumulative total prescriptions since launch[4] - Approximately 33% of KMT2A patients proceed to hematopoietic stem cell transplantation (HSCT)[4] - Approximately 70% of KMT2A use is in the 2L/3L setting[4] - Approximately 35-40% of KMT2A patients resume Revuforj post-HSCT[4] - Revuforj is positioned to potentially capture 40-45% of the addressable AML population[9] Niktimvo Highlights - Approximately 90% of patients who started Niktimvo treatment in Q1 remained on treatment[14] - Approximately 80% of U S bone marrow transplant centers have ordered Niktimvo[14] Market Opportunity - Revuforj's second indication unlocks a $2 billion+ U S market opportunity in relapsed/refractory (R/R) acute leukemia alone[6] - The initial Niktimvo indication represents a $2 billion U S market opportunity, with potential for expansion[15]

Financial Performance - Revuforj achieved $32.0 million in net revenue in Q3 2025, a 12% increase from Q2 2025, with approximately 850 prescriptions, a 25% increase from the previous quarter [83]. - Niktimvo generated $45.8 million in net revenue in Q3 2025, representing a 27% increase over Q2 2025, with the company's share of collaboration revenue at $13.9 million [87]. - For the nine months ended September 30, 2025, the company reported a net loss of $217.4 million, compared to a net loss of $224.6 million for the same period in 2024 [82]. - Total revenues increased to $45.9 million for the three months and $103.6 million for the nine months ended September 30, 2025, compared to $12.5 million and $16.0 million in the prior year [104]. - Net loss for the three months ended September 30, 2025, was $60.7 million, compared to a net loss of $84.1 million in the prior year [104]. Cash and Investments - As of September 30, 2025, the company had an accumulated deficit of $1.4 billion and cash, cash equivalents, and investments totaling $456.1 million [82]. - The company has cash and cash equivalents of $116.8 million and short and long-term investments totaling $339.3 million as of September 30, 2025 [134]. - Net cash used in operating activities increased to $253.5 million for the nine months ended September 30, 2025, from $217.5 million in the prior year [117]. - Net cash provided by investing activities was $208.5 million for the nine months ended September 30, 2025, compared to $49.2 million in the prior year [118][119]. - The company entered into a sales agreement for an At-the-Market Offering Program with the potential to raise up to $200 million, with $157.9 million available as of September 30, 2025 [131]. Expenses - Total operating expenses were $103.3 million for the three months and $314.2 million for the nine months ended September 30, 2025, an increase of $1.2 million and $54.9 million, respectively, from the prior year [104]. - Research and development expenses are expected to grow as the company continues to focus on advancing its clinical development programs [92]. - Selling, general and administrative expenses increased by $13.8 million for the three months and $46.6 million for the nine months ended September 30, 2025, primarily due to commercial-related costs [110]. - Research and development expenses decreased by $14.7 million for the three months ended September 30, 2025, but increased by $4.0 million for the nine months compared to the prior year [109][110]. Regulatory and Development Updates - Revuforj received FDA approval on October 24, 2025, for treating R/R AML with a susceptible NPM1 mutation, making it the first FDA-approved therapy for both R/R AML with an NPM1 mutation and R/R acute leukemia with a KMT2A translocation [83]. - Ongoing trials for revumenib include pivotal Phase 3 and Phase 1/2 studies evaluating its efficacy in various acute leukemia subtypes [83][84]. - Axatilimab is in development for newly diagnosed cGVHD patients and idiopathic pulmonary fibrosis, with ongoing trials expected to complete enrollment by the end of 2025 [87]. Future Outlook and Risks - The company anticipates stable selling, general, and administrative expenses in the coming years as it supports the commercialization of Revuforj and Niktimvo [96]. - The company expects to support future cash needs through equity offerings, debt financings, and collaboration arrangements, with no committed external source of liquidity [125]. - The company is subject to risks including unfavorable interest rates and geopolitical unrest, which could impact operations and financing [132]. - The company faces challenges in obtaining regulatory approvals and protecting intellectual property rights, which are common risks in the pharmaceutical industry [133].

Financial Performance - Total revenue for Q3 2025 was $45.9 million, representing a 21% growth over Q2 2025[1] - Revuforj net revenue was $32.0 million, with total prescriptions increasing by 25% over Q2 2025[1][4] - Niktimvo net revenue was $45.8 million, reflecting a 27% increase over Q2 2025, with Syndax's share of collaboration revenue at $13.9 million[1][9] - Total revenues for the three months ended September 30, 2025, were $45.871 million, compared to $12.5 million for the same period in 2024, representing a significant increase[32] - Product revenue for the nine months ended September 30, 2025, was $80.649 million, while collaboration revenue was $22.975 million, indicating strong performance in both areas[32] Expenses - Research and development expenses decreased to $56.3 million from $71.0 million year-over-year, primarily due to a prior milestone payment[11] - Selling, general and administrative expenses increased to $44.9 million from $31.1 million year-over-year, driven by higher commercial costs[12] - Total operating expenses for the three months ended September 30, 2025, were $103.297 million, slightly higher than $102.077 million for the same period in 2024[32] - For the full year 2025, the company expects total expenses to be between $380 million and $385 million, excluding an estimated $45 million in non-cash stock compensation[14] Net Loss - The net loss attributable to common stockholders for Q3 2025 was $60.7 million, or $0.70 per share, compared to a loss of $84.1 million, or $0.98 per share, in the prior year[13] - The net loss for the three months ended September 30, 2025, was $60.715 million, compared to a net loss of $84.126 million for the same period in 2024, showing an improvement[32] - Basic loss per share attributable to common stockholders for the three months ended September 30, 2025, was $0.70, down from $0.98 in the same period of 2024[32] - The company reported a loss from operations of $57.426 million for the three months ended September 30, 2025, compared to a loss of $89.577 million for the same period in 2024, indicating operational improvements[32] Cash and Equity - As of September 30, 2025, the company had $456.1 million in cash, cash equivalents, and investments[8] - Total stockholders' equity as of September 30, 2025, was $115.430 million, a decrease from $288.124 million as of December 31, 2024[30] - Cash, cash equivalents, and investments totaled $456.125 million as of September 30, 2025, down from $692.404 million as of December 31, 2024, indicating a reduction in liquidity[30] - Common stock outstanding increased to 86,905,343 shares as of September 30, 2025, from 85,694,443 shares as of December 31, 2024, reflecting ongoing equity financing activities[30] Product Development - Revuforj received FDA approval for R/R NPM1m AML on October 24, 2025, marking a significant milestone for the product[5] - The company is advancing multiple clinical trials for Revuforj and Niktimvo, aiming to unlock their multi-billion-dollar potential in various indications[3][19] - Research and development expenses for the nine months ended September 30, 2025, were $180.143 million, compared to $176.118 million for the same period in 2024, reflecting continued investment in product development[32]

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]

Group 1 - The article does not provide any specific content related to a company or industry [1]

Core Viewpoint - Qiagen (QGEN) is anticipated to report a year-over-year decline in earnings despite an increase in revenues for the quarter ended September 2025, with the actual results being a significant factor influencing its near-term stock price [1][2]. Earnings Expectations - The consensus estimate for Qiagen's quarterly earnings is $0.58 per share, reflecting a year-over-year decrease of 1.7%, while revenues are projected to be $525.99 million, representing a 4.8% increase from the previous year [3]. - The earnings report is scheduled for release on November 4, and the stock may experience upward movement if the reported figures exceed expectations, whereas a miss could lead to a decline [2]. Estimate Revisions - Over the past 30 days, the consensus EPS estimate has been revised down by 0.67%, indicating a bearish sentiment among analysts regarding the company's earnings prospects [4]. - The Most Accurate Estimate for Qiagen is lower than the Zacks Consensus Estimate, resulting in an Earnings ESP of -0.73%, which complicates the prediction of an earnings beat [12]. Earnings Surprise History - In the last reported quarter, Qiagen met the expected earnings of $0.60 per share, resulting in no surprise [13]. - Over the last four quarters, the company has surpassed consensus EPS estimates in two instances [14]. Industry Context - Syndax Pharmaceuticals (SNDX), a peer in the Zacks Medical - Biomedical and Genetics industry, is expected to report a loss of $0.74 per share for the same quarter, marking a year-over-year change of +24.5%, with revenues projected at $48.69 million, up 289.5% from the previous year [18]. - Despite a recent downward revision of 13.9% in the consensus EPS estimate for Syndax, it currently holds an Earnings ESP of +0.23%, although it has a Zacks Rank of 4 (Sell), making predictions of an earnings beat challenging [19][20].

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]

Core Insights - Syndax Pharmaceuticals received extended FDA approval for its leukemia treatment Revuforj, allowing it to be used for a broader patient population [1] Company Overview - Syndax Pharmaceuticals is focused on innovative biotechnology solutions, particularly in the field of leukemia treatment [1] - The company aims to reshape treatment paradigms through novel mechanisms of action and first-in-class therapies [1] Market Implications - The extended approval of Revuforj may enhance the market opportunity for Syndax Pharmaceuticals by increasing the potential patient base [1] - The biotechnology sector is characterized by breakthrough science that can lead to significant returns, highlighting the importance of careful scrutiny in investment decisions [1]