Syndax Pharmaceuticals, Inc. (SNDX) Bundle
Syndax Pharmaceuticals, Inc. (SNDX) is no longer a pure-play clinical-stage biotech; it's a commercial-stage contender, so are you tracking their transition from R&D expense to product revenue? With a market capitalization of roughly $1.51 billion USD as of November 2025 and total revenue hitting $45.9 million in the third quarter of 2025-a 21% jump over the prior quarter-the company's dual-product launch of Revuforj and Niktimvo is defintely a case study in execution. That third-quarter revenue, driven by $32.0 million in Revuforj net sales and a key FDA approval for a second indication in late October 2025, shows real commercial momentum, but what does this mean for their path to sustained profitability with $456.1 million in cash reserves? We need to break down the history, ownership structure, and the mechanics of how this company is actually making money to see if the valuation holds up.
Syndax Pharmaceuticals, Inc. (SNDX) History
Syndax Pharmaceuticals, Inc. began with a clear, ambitious goal: to revolutionize cancer treatment through innovative drug development. The company's history is a classic biotech story, starting with foundational science and evolving into a commercial-stage entity with two FDA-approved, first-in-class therapies, a significant shift that occurred in late 2024 and throughout the 2025 fiscal year.
Given Company's Founding Timeline
Year established
Syndax Pharmaceuticals was established in 2005, marking its inception as a research-focused startup dedicated to oncology.
Original location
The company was founded in Waltham, Massachusetts, a key hub for biopharmaceutical innovation in the United States.
Founding team members
The company was co-founded by two scientific heavyweights: Eckard Weber, M.D., from Domain Associates, and Ronald Evans, Ph.D., from the Salk Institute for Biological Studies. Dr. Arlene M. Morris served as President and CEO from 2005 to 2015, playing a critical role in the company's early direction.
Initial capital/funding
Syndax secured its first major financial backing in April 2007, closing a Series A financing round totaling $40 million. This capital was crucial for funding the initial clinical pipeline development.
Given Company's Evolution Milestones
| Year | Key Event | Significance |
|---|---|---|
| 2010 | Initiated first Phase 1 clinical trial for lead compound, SNDX-275 (entinostat). | Marked the company's transition from preclinical research to clinical development, establishing its focus on epigenetic research for cancer. |
| 2024 (Late Nov) | FDA approval and launch of Revuforj® (revumenib) for R/R acute leukemia with a KMT2A translocation. | Propelled Syndax into the commercial stage with the first and only FDA-approved menin inhibitor, a practice-changing therapy. |
| 2024 (Late) | FDA approval of Niktimvo™ (axatilimab-csfr) for chronic Graft-Versus-Host Disease (GVHD). | Secured a second first-in-class approval, diversifying the commercial portfolio and targeting a significant unmet medical need. |
| 2025 (Q2) | Reported Revuforj net revenue of $28.6 million and Niktimvo collaboration revenue of $9.4 million. | Demonstrated strong commercial traction in the first full quarter of dual product launches, validating the shift to a commercial-stage company. |
| 2025 (Oct 25) | Anticipated FDA approval for a second indication for Revuforj in relapsed/refractory mutant NPM1 acute myeloid leukemia (mNPM1 AML). | Significantly expanded the total addressable market for Revuforj, reinforcing Syndax's leadership in the menin inhibition space. |
Given Company's Transformative Moments
The most transformative period for Syndax was the shift from a clinical-stage developer to a dual-product commercial entity in late 2024 and 2025. Honestly, this is the entire story right now.
The simultaneous approvals of Revuforj and Niktimvo in 2024 were the inflection point, moving the company from costly R&D to generating substantial product revenue. This commercial success is defintely building momentum, with Revuforj net revenue hitting $28.6 million in Q2 2025, a 43% increase over the first quarter.
Also, the strategic financial moves solidified the company's runway to profitability. Syndax secured a $350 million royalty funding agreement with Royalty Pharma based on Niktimvo's U.S. net sales, which, combined with anticipated product revenue, is expected to fund operations through profitability.
- First-in-Class Leadership: Revuforj is the first and only FDA-approved menin inhibitor, giving Syndax a strong competitive moat in acute leukemia.
- Strategic Partnership: The co-commercialization of Niktimvo with Incyte allows Syndax to share the commercial burden while capturing a 50% share of the net commercial profit/loss, which was already a positive $9.4 million in collaboration revenue for Syndax in Q2 2025.
- Pipeline Expansion: The anticipated second indication approval for Revuforj in October 2025 for mNPM1 AML is critical, as it significantly broadens the patient population and revenue potential.
To dive deeper into the financial mechanics of this commercial transition, you should check out Breaking Down Syndax Pharmaceuticals, Inc. (SNDX) Financial Health: Key Insights for Investors. For the full year 2025, the company is guiding for total research and development plus selling, general and administrative expenses to be between $370 million and $390 million, so the revenue growth is directly offsetting this significant operational spend.
Syndax Pharmaceuticals, Inc. (SNDX) Ownership Structure
Syndax Pharmaceuticals is controlled primarily by institutional investors, holding the vast majority of shares, with management and co-founders maintaining a small but significant insider stake that aligns their interests with shareholder returns.
Syndax Pharmaceuticals, Inc.'s Current Status
Syndax Pharmaceuticals, Inc. is a publicly traded, commercial-stage biopharmaceutical company focused on innovative cancer therapies. It is listed on the Nasdaq Stock Market under the ticker symbol SNDX. As of November 2025, the company commands a market capitalization of approximately $1.53 billion, which reflects its transition into a commercial entity following the FDA approvals of its key products, Revuforj (revumenib) and Niktimvo (axatilimab-csfr).
While the company reported Q3 2025 total revenue of $45.87 million, it is still in a high-growth, pre-profitability phase, posting a net loss of $71.8 million for the quarter. The balance sheet remains strong, with $517.9 million in cash, cash equivalents, and investments as of June 30, 2025, which is expected to fund operations to profitability. If you want a deeper dive into the financials, you should check out Breaking Down Syndax Pharmaceuticals, Inc. (SNDX) Financial Health: Key Insights for Investors.
Syndax Pharmaceuticals, Inc.'s Ownership Breakdown
The company's ownership structure is heavily weighted toward professional money managers-a common pattern for a high-potential, commercial-stage biotech firm. This means institutional buying and selling can defintely drive stock price volatility.
| Shareholder Type | Ownership, % | Notes |
|---|---|---|
| Institutional Investors | 75.47% | Includes mutual funds, hedge funds, and other institutions. Vanguard Group Inc. and BlackRock, Inc. are among the largest holders. |
| Public & Retail Investors | 20.43% | Represents the float held by individual investors and other public entities. (Calculated) |
| Insiders | 4.10% | Includes executives (like the CEO) and Board of Directors. This group has been a net seller in recent quarters. |
Syndax Pharmaceuticals, Inc.'s Leadership
The company is steered by an experienced management team and a long-tenured Board of Directors. The average tenure for the Board is approximately 9.3 years, providing strong institutional memory and oversight.
- Michael A. Metzger: Chief Executive Officer (CEO) & Director. Appointed in February 2022, his total yearly compensation is approximately $7.71 million.
- Keith Goldan: Chief Financial Officer (CFO), Treasurer & Chief Accounting Officer. He brings extensive experience from other publicly traded pharmaceutical companies.
- Dennis Podlesak: Independent Chairman of the Board.
- Peter Ordentlich: Co-Founder & Chief Scientific Officer.
- Steven Closter: Chief Commercial Officer, a critical role given the recent product launches.
The leadership is focused on commercial execution and expanding the pipeline, which is a clear action point for investors to monitor.
Syndax Pharmaceuticals, Inc. (SNDX) Mission and Values
Syndax Pharmaceuticals, Inc. is driven by a singular purpose: to extend and improve the lives of cancer patients by translating cutting-edge science into commercial-stage therapies. Their core values center on an enduring passion for the patient community, which fuels their clinical and commercial execution.
Syndax Pharmaceuticals' Core Purpose
You're investing in a biotech firm, so you need to know what they stand for beyond the balance sheet. Syndax Pharmaceuticals' cultural DNA is built on scientific excellence and a relentless focus on patients with high unmet medical needs like acute leukemia and chronic graft-versus-host disease (cGVHD).
Official mission statement
The company's mission is to obtain regulatory approval and commercialize drugs that extend and improve the lives of cancer patients. This is not just a statement; it's a clear roadmap for their operations, focusing on three key areas:
- Draw on the newest scientific research and advances.
- Collaborate with determined problem solvers.
- Identify value in overlooked aspects of science.
This mission directly translates to their 2025 success, like the anticipated FDA approval for Revuforj (revumenib) in R/R mNPM1 AML, which was granted Priority Review with a PDUFA action date of October 25, 2025. That approval alone expands their addressable patient population by over 6,000 people.
Vision statement
Syndax Pharmaceuticals' vision is to realize a future where people with cancer live longer and better than ever before. They are working to set a new standard for developing medicines in oncology, prioritizing collaboration, shared learning, and excellence. It's a bold vision, but their commercial-stage status makes it tangible.
- Realize a future where cancer patients live longer and better.
- Set the new standard for developing oncology medicines.
- Dedication to serving the patient community.
Honestly, the vision is being funded by strong commercial performance, too. For instance, the combined net product sales for Revuforj and Niktimvo (axatilimab-csfr) were nearly $100 million in the first half of 2025. That capital is what allows them to pursue high-risk, high-reward trials like the pivotal EVOLVE-2 trial in the frontline setting for acute leukemia. Exploring Syndax Pharmaceuticals, Inc. (SNDX) Investor Profile: Who's Buying and Why?
Syndax Pharmaceuticals' slogan/tagline
While they don't use one single, formal slogan in their investor materials, the company's messaging consistently reinforces the idea of 'reimagining cancer care.' They are focused on developing first-in-class therapies (a drug that works by a unique mechanism) in areas of significant unmet need, which is a defintely powerful tagline in itself.
- Advancing the next generation of targeted treatments.
- Reimagining cancer care.
- Developing first-in-class therapies.
Here's the quick math on their impact: Revuforj net revenue hit $28.6 million in Q2 2025, representing a 43% quarter-over-quarter growth, even with patients pausing treatment for a stem cell transplant. That kind of rapid adoption shows physicians and patients are embracing their novel approach to care.
Syndax Pharmaceuticals, Inc. (SNDX) How It Works
Syndax Pharmaceuticals, Inc. operates as a commercial-stage oncology innovator, developing and selling first-in-class targeted therapies for cancers and severe immune-mediated diseases with high unmet medical need, like acute leukemia and chronic graft-versus-host disease (cGVHD). The company generates revenue through direct product sales of its menin inhibitor, Revuforj, and collaboration revenue from its co-commercialized CSF-1R-blocking antibody, Niktimvo, which together brought in a total revenue of $45.9 million in the third quarter of 2025.
Given Company's Product/Service Portfolio
| Product/Service | Target Market | Key Features |
|---|---|---|
| Revuforj (revumenib) | Relapsed/Refractory (R/R) Acute Leukemia (AML/ALL) with KMT2A-rearrangement or NPM1-mutation | First and only FDA-approved oral menin inhibitor; targets specific genetic drivers of leukemia; FDA approval for R/R mNPM1 AML secured on October 24, 2025. |
| Niktimvo (axatilimab-csfr) | Chronic Graft-Versus-Host Disease (cGVHD) after failure of at least two prior systemic therapies | First-in-class monoclonal antibody that blocks the CSF-1 receptor; co-commercialized with Incyte; offers a novel mechanism of action for a serious complication of stem cell transplant. |
Given Company's Operational Framework
The operational process at Syndax is a focused, two-pronged approach: research and commercialization. The company dedicates significant capital to advancing its pipeline, with total research and development plus selling, general, and administrative (SG&A) expenses guided to be between $415 million and $435 million for the full year 2025. This investment fuels a cycle of value creation:
- Targeted Discovery: Identify and develop first-in-class therapies, like the menin inhibitor, for specific, high-need genetic subsets of cancer.
- Clinical Execution: Run pivotal trials (e.g., AUGMENT-101) to secure regulatory approvals and expand product labels, such as the recent FDA approval of Revuforj for R/R mNPM1 AML.
- Strategic Commercialization: Directly manage the sales and marketing of Revuforj, which generated $32.0 million in net revenue in Q3 2025.
- Partnership Leveraging: Use a co-commercialization model for Niktimvo with Incyte, which allows Syndax to record 50% of the net commercial profit, amounting to $13.9 million in collaboration revenue in Q3 2025.
Honestly, the co-commercialization model for Niktimvo is a defintely smart way to share the launch costs and market reach. You can see a deeper dive on the financials at Breaking Down Syndax Pharmaceuticals, Inc. (SNDX) Financial Health: Key Insights for Investors.
Given Company's Strategic Advantages
Syndax's market success hinges on a few clear, strategic advantages that differentiate it in the competitive biopharmaceutical landscape.
- First-Mover Advantage in Menin Inhibition: Revuforj is the first and only FDA-approved menin inhibitor, giving the company a head start in capturing the acute leukemia market driven by KMT2A-rearrangement and NPM1-mutation, which together represent about 40-50% of acute leukemia patients.
- Pipeline Expansion Strategy: The company is actively moving its two approved products into earlier lines of therapy and combination regimens. For example, pivotal trials for Revuforj in combination with standard-of-care agents for newly diagnosed acute leukemia are underway.
- Strong Financial Runway: With $456.1 million in cash, cash equivalents, and investments as of Q3 2025, management expects this capital, plus growing product revenue, will fund the company to profitability.
- Differentiated Mechanism of Action: Niktimvo is a novel treatment for cGVHD, a significant post-transplant complication, which has achieved profitability for Syndax in its first full quarter post-launch, demonstrating rapid market adoption.
What this financial stability hides is the continued need for high R&D spending to maintain the lead, but the focus on first-in-class medicines for multi-billion-dollar markets is a solid foundation.
Syndax Pharmaceuticals, Inc. (SNDX) How It Makes Money
Syndax Pharmaceuticals, Inc. generates revenue primarily through the commercial sales of its two FDA-approved, first-in-class oncology and rare disease therapies: the menin inhibitor Revuforj (revumenib) and the CSF-1R-blocking antibody Niktimvo (axatilimab-csfr). The business model is a blend of direct product sales and a strategic profit-sharing collaboration, which is typical for a biotech company transitioning to commercial-stage operations.
Syndax Pharmaceuticals, Inc.'s Revenue Breakdown
In the third quarter of 2025, the company's total revenue reached $45.9 million, showing strong commercial momentum with a 21% increase over the prior quarter. This revenue is split between direct sales of its wholly-owned drug and collaboration income from its partnership with Incyte.
| Revenue Stream | % of Total (Q3 2025) | Growth Trend (Q/Q) |
|---|---|---|
| Revuforj Net Revenue | 69.7% | Increasing (12% Q/Q) |
| Niktimvo Collaboration Revenue | 30.3% | Increasing (Based on 27% Q/Q partner sales growth) |
The majority of the revenue, 69.7%, comes from Revuforj, which is a menin inhibitor for relapsed or refractory (R/R) acute leukemia. The remaining 30.3% is collaboration revenue derived from Niktimvo, which treats chronic graft-versus-host disease (cGVHD). It's a clean and defintely growing revenue picture.
Business Economics
The core economics of Syndax Pharmaceuticals are based on the high-value, low-volume model common to specialty oncology and rare disease drugs, supported by a favorable gross margin and a smart co-commercialization agreement.
- Specialty Drug Pricing: The pricing strategy reflects the significant unmet medical need and the first-in-class nature of their therapies. For example, the Wholesale Acquisition Cost (WAC) for Revuforj is set at approximately $474,000 annually for a course of treatment. Niktimvo, an infused product, has a WAC of $11,550.00 for a 22 mg vial. This premium pricing is essential to recoup the billions spent on research and development (R&D).
- High Gross Margin: The gross margin for the product portfolio is exceptionally high, standing at 97.23% as of the third quarter of 2025. This means that for every dollar of net product revenue, nearly all of it remains after accounting for the cost of goods sold (COGS). The real cost is in the R&D and commercial launch, not the pill itself.
- Niktimvo Profit Share: With Niktimvo, Syndax records its revenue as collaboration income, representing 50% of the net commercial profit (net product revenue minus cost of sales and commercial expenses) from its partner, Incyte. This structure reduces Syndax's commercial risk while providing a steady, high-margin income stream, with the margin contribution expected to be in the 20-30% range of Niktimvo net sales in the near term.
- Market Opportunity: The total market for the menin inhibitor class, led by Revuforj, is estimated to reach a peak of $5 billion, with the current relapsed disease market alone valued at around $2 billion. This massive addressable market is the engine for future growth.
Syndax Pharmaceuticals, Inc.'s Financial Performance
While the company is in a rapid commercial ramp-up phase, its financial performance in 2025 shows a clear path of growing sales outpacing high, but stable, operating expenses.
- Revenue Trajectory: Total product and collaboration revenue for the first three quarters of 2025 was approximately $117.9 million ($34.0M in Q1, $38.0M in Q2, and $45.9M in Q3), demonstrating accelerating sales momentum.
- Net Loss: For the third quarter of 2025, Syndax reported a net loss of $60.7 million, a significant improvement from the $84.1 million loss in the comparable prior year period. The loss is narrowing as sales climb.
- Operating Expenses: The company continues to invest heavily in its future. In Q3 2025, Research & Development (R&D) expenses were $56.3 million, and Selling, General, and Administrative (SG&A) expenses were $44.9 million, driven by the commercial launches of its two key products. Full-year 2025 total R&D plus SG&A expenses (excluding non-cash stock compensation) are guided to be between $380 million and $385 million.
- Cash Runway: As of September 30, 2025, Syndax maintained a strong cash position with $456.1 million in cash, cash equivalents, and investments, which management expects will fund the company to profitability.
The company is effectively converting its R&D investment into commercial sales, which is the critical transition point for any biotech. You can dive deeper into the metrics that matter most to investors in Breaking Down Syndax Pharmaceuticals, Inc. (SNDX) Financial Health: Key Insights for Investors.
Syndax Pharmaceuticals, Inc. (SNDX) Market Position & Future Outlook
Syndax Pharmaceuticals, Inc. is rapidly transitioning from a clinical-stage biotech to a commercial-stage oncology company, driven by two recent FDA-approved, first-in-class therapies: Revuforj (revumenib) and Niktimvo (axatilimab-csfr). The company's immediate future hinges on maximizing the penetration of these two products, which management projects to unlock a combined $10 billion market opportunity.
You're looking at a company that has successfully navigated the most difficult regulatory hurdles, but still needs to prove long-term commercial execution. For the third quarter of 2025, total revenue hit $45.9 million, a solid 21% sequential growth, but the company reported a net loss of $60.7 million, which shows the significant investment still required to capture that massive market potential.
Competitive Landscape
Syndax competes in highly specialized, yet high-value, hematology and oncology niches. Its competitive edge comes from being the first-to-market with novel mechanisms of action, forcing larger players to react. To be fair, this is a niche game right now, so direct market share is tricky to quantify against multi-billion dollar giants like Novartis or Merck, but we can look at penetration and scale.
| Company | Market Share, % (Proxy) | Key Advantage |
|---|---|---|
| Syndax Pharmaceuticals, Inc. | ~25% (R/R KMT2A-r AML patient penetration in first 7 mos of launch) | First-in-class menin inhibitor (Revuforj); Novel CSF-1R mechanism (Niktimvo) |
| Incyte | $2.925B - $2.975B (2025 Jakafi Net Revenue Guidance) | Established market leader in GVHD and MPNs (Jakafi); Global commercial reach (Niktimvo partner) |
| Protagonist Therapeutics | N/A (Clinical-stage in hematology) | Proprietary oral peptide platform; NDA filings expected by end of 2025 |
Opportunities & Challenges
The biggest opportunity is expanding the label for both products. Management is focused on moving both Revuforj and Niktimvo into the frontline setting (earlier treatment), which dramatically increases the patient population and potential sales. That's the defintely the multi-billion dollar play.
Here's the quick math on the near-term: Niktimvo, for chronic graft-versus-host disease (cGVHD), is currently approved for patients who have failed at least two prior lines of therapy (3L+), a group of about 6,500 patients in the U.S.. Moving that drug into the first-line setting, potentially in combination with Incyte's Jakafi, is the path to the estimated $1 billion peak sales potential.
| Opportunities | Risks |
|---|---|
| Expand Revuforj into frontline AML (acute myeloid leukemia) with ongoing Phase 3 trials. | Sustained net losses; Q3 2025 net loss was $60.7 million, demanding continued capital management. |
| Advance Niktimvo into newly diagnosed cGVHD via combination trials with Jakafi and corticosteroids. | Intense competition in the broader oncology market from large pharmaceutical companies with superior resources. |
| Capitalize on first-in-class status for both Revuforj (menin inhibitor) and Niktimvo (CSF-1R inhibitor). | Dependence on successful commercialization and market adoption for two recently launched products. |
Industry Position
Syndax holds a strong and defensible position as a niche innovator in high-unmet-need hematology. The company is no longer a pure clinical-stage bet; it is a commercial entity with FDA-approved products.
- Owns two approved, first-in-class therapies, Revuforj and Niktimvo, which is rare for a company of its size.
- Cash position of $456.1 million as of Q3 2025 is expected to fund the business through to profitability, mitigating near-term financing risk.
- Revuforj's approval for R/R NPM1-mutant AML in October 2025 makes it the only approved therapy for both KMT2A-r and NPM1m acute leukemias.
- The co-commercialization partnership with Incyte for Niktimvo provides a commercial infrastructure advantage that a smaller biotech would otherwise lack.
To understand the foundation of this strategy, you can review the Mission Statement, Vision, & Core Values of Syndax Pharmaceuticals, Inc. (SNDX).

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