Syndax Pharmaceuticals (SNDX) risk factors, FY2025 10-K

Syndax Pharmaceuticals's FY2025 10-K, filed Feb 26, 2026, lists 67 risk factors in 4 groups. Against the prior year's 64: 14 new, 11 dropped, 19 substantially reworded.

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Risk factors listed
674 groups
New this year
14vs 64 last year
Dropped
11since the prior 10-K
Substantially reworded
19of those kept
Section length
26k wordsItem 1A

What the changes say

  • Syndax transitioned to a commercial-stage company, launching Revuforj in November 2024 and Niktimvo in February 2025.
  • Risks now emphasize manufacturing dependencies on Incyte and third parties, and new commercial scaling challenges.
  • New tax legislation in July 2025 and administrative pricing policies introduce fresh regulatory and financial uncertainties.

What changed since the prior 10-K

New

  • New

    We are currently developing several product candidates. If we are unable to successfully complete clinical development of, obtain regulatory approval for, and commercialize our product candidates, our business prospects may be significantly harmed

    Incyte might fail to perform or deprioritize investments in axatilimab, and our clinical data or patient enrollment could face delays.

  • New

    Failure to comply with regulatory requirements or unanticipated problems with Revuforj or Niktimvo may result in various adverse actions such as the suspension or withdrawal of Revuforj or Niktimvo, closure of a facility or enforcement of substantial penalties or fines

    Regulatory compliance failures or problems with Revuforj or Niktimvo could lead to suspension, withdrawal, or heavy fines.

  • New

    While we have product, collaboration and milestone revenue, we may never achieve or maintain profitability

    We may never achieve or maintain profitability and could require additional capital that is unavailable on acceptable terms.

  • NewRisks Related to Our Business and Industry

    our ability to maintain, enforce, and defend third party challenges to our intellectual property rights in and to Revuforj and Niktimvo

    Third-party challenges to our intellectual property for Revuforj and Niktimvo could impair commercialization and revenue generation.

  • NewRisks Related to Our Business and Industry

    We have recently begun commercialization efforts and the sales, marketing, and distribution of Revuforj, Niktimvo, or any future approved products may be unsuccessful or less successful than anticipated

    With no prior experience commercializing products, our sales, marketing, and distribution efforts for Revuforj and Niktimvo may fail.

  • NewRisks Related to Our Business and Industry

    If the market opportunities for our products are smaller than we believe they are, our revenue may be adversely affected, and our business may suffer

    Our addressable patient populations for Revuforj and Niktimvo could be smaller than projected, limiting revenue potential.

  • NewRisks Related to Our Business and Industry

    The regulatory approval processes of the FDA and foreign regulatory authorities are lengthy, time-consuming and inherently unpredictable. Our inability to obtain regulatory approval for our product candidates would harm our business

    Lengthy and unpredictable FDA and foreign regulatory approval processes could delay or prevent commercializing our product candidates.

  • NewRisks Related to Our Business and Industry

    Disruptions at the FDA and other government agencies caused by layoffs, funding shortages or global health concerns could negatively impact our business

    Government shutdowns like the one in October 2025 and FDA disruptions can slow product reviews and clinical trial approvals.

  • NewRisks Related to Our Business and Industry

    unfavorable publicity relating to our products

    Unfavorable publicity for Revuforj, Niktimvo, or future products could prevent adequate market acceptance and profitability.

  • NewRisks Related to Our Business and Industry

    We are in the process of building and maintaining our sales, marketing and distribution infrastructure

    We must invest heavily of financial and management resources to build and maintain our sales, marketing, and distribution infrastructure.

  • NewRisks Related to Our Business and Industry

    We currently rely, and expect to continue to rely, on third-party contract manufacturers as well as Incyte for all of our required raw materials, active pharmaceutical ingredients and finished product for our preclinical research, clinical trials, and commercial manufacturing and distribution

    We rely entirely on third-party contract manufacturers and Incyte for raw materials, active ingredients, and finished drug supply.

  • NewRisks Related to Our Business and Industry

    for healthcare products and services, which could result in reduced demand for our products or additional pricing pressures

    New administration policies demanding Most-Favored Nation pricing and direct-to-patient discounts create additional pricing and revenue uncertainty.

  • NewRisks Related to Our Business and Industry

    consumer health data (including imposing stringent requirements for consents), provides consumers certain rights with respect to their health data, and creates a private right of action to allow individuals to sue for violations of the law. Other states have proposed, enacted or are considering similar laws

  • NewRisks Related to Intellectual Property

    and our and our licensors’ patents or other intellectual property rights may not be effective or sufficient to prevent them from competing

Dropped

  • DroppedRisks Related to Our Business and Industry

    We have limited experience in generating revenue from product sales

  • DroppedRisks Related to Our Business and Industry

    attracting, hiring, and retaining qualified personnel

  • DroppedRisks Related to Our Business and Industry

    closure of the facility, enforcement of substantial fines, injunctions, or the imposition of civil or criminal penalties

  • DroppedRisks Related to Our Business and Industry

    If Revuforj, Niktimvo or future approved product candidates do not achieve an adequate level of acceptance by physicians, hospitals, healthcare payors and patients, we may not generate sufficient revenue to become or remain profitable

  • DroppedRisks Related to Our Business and Industry

    We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively

  • DroppedRisks Related to Our Business and Industry

    Current and future legislation may increase the difficulty and cost for us to commercialize our product candidates and affect the prices we may obtain

  • DroppedRisks Related to Our Business and Industry

    regulate post-approval activities and affect our ability to profitably sell any product candidate for which we obtain marketing approval

    Limited experience generating revenue from product sales of revumenib and axatilimab.

  • DroppedRisks Related to Our Business and Industry

    There have been executive, judicial and Congressional challenges to certain aspects of the Affordable Care Act

    Risks related to attracting, hiring, and retaining qualified personnel.

  • DroppedRisks Related to Our Business and Industry

    To market Revuforj and Niktimvo or any approved product candidate in the future, we must continue building our sales, marketing, distribution, managerial and other non-technical capabilities or make arrangements with third parties to perform these services, as we do not presently have all of these capabilities

  • DroppedRisks Related to Our Business and Industry

    implement and maintain specific security measures or industry-standard or reasonable security measures to protect our information technology systems and sensitive data

  • DroppedRisks Related to Intellectual Property

    or developments. If securities analysts or investors perceive these results to be negative, it could have a downward effect on the price of shares of our common stock

Reworded

  • 100% rewritten

    The market price of our stock may be volatile and you could lose all or part of your investment

    Shifted from general stock volatility factors to financing dilution risks and debt arrangements.

  • 100% rewrittenRisks Related to Ownership of Our Common Stock and Other General Matters

    The market price of our stock may be volatile and you could lose all or part of your investment

    Moved stock price volatility and market fluctuation factors into this numbered risk slot.

    Was: The market price of our stock may be volatile and you could lose all or part of your investment

  • 100% rewrittenRisks Related to Our Financial Position and Capital Needs

    While we have product revenue, we may never achieve or maintain profitability

    Updated to reflect that we now generate product revenue from Revuforj and Niktimvo.

  • 99% rewrittenRisks Related to Our Business and Industry

    We are currently developing several product candidates. If we are unable to successfully complete clinical development of, obtain regulatory approval for, and commercialize our product candidates, our business prospects will be significantly harmed

    Added nuance that financial success depends on expanding approved indications for Revuforj and Niktimvo.

  • 95% rewrittenRisks Related to Our Financial Position and Capital Needs

    Changes in tax laws or regulations could materially adversely affect our company

    Updated to cite specific impacts from the July 2025 OBBBA legislation, including bonus depreciation and R&E expensing.

  • 93% rewritten

    Revuforj, Niktimvo and our future products may not achieve adequate market acceptance among physicians, patients, healthcare payors and others in the medical community to be commercially successful

    Replaced manufacturing reliance text with market acceptance risks for Revuforj, Niktimvo, and future products.

    Was: Revuforj, Niktimvo and our future product candidates may not achieve adequate market acceptance among physicians, patients, healthcare payors and others in the medical community to be commercially successful

  • 84% rewrittenRisks Related to Our Business and Industry

    Our data processing activities subject us to numerous data privacy and security obligations, such as various laws, regulations, guidance, industry standards, external and internal privacy and security policies, contractual requirements, and other obligations relating to data privacy and security

    Streamlined data privacy and security obligations text by removing redundant introductory clauses.

  • 77% rewrittenRisks Related to Our Business and Industry

    our ability to negotiate preferential formulary status for our product candidates

    Added a specific warning regarding intense competition and our ability to negotiate preferential formulary status.

  • 72% rewritten

    Summary of Selected Risks

  • 71% rewrittenRisks Related to Intellectual Property

    We may not be able to protect our intellectual property rights throughout the world

  • 58% rewrittenRisks Related to Our Business and Industry

    changes in the approval policies or regulations that render our preclinical and clinical data insufficient for approval

  • 57% rewrittenRisks Related to Our Financial Position and Capital Needs

    We have incurred net losses since our inception, except 2021, and anticipate that we will continue to incur net losses for the near future

    Was: We have incurred net losses since our inception, except 2021, and anticipate that we will continue to incur net losses for the foreseeable future

  • 57% rewrittenRisks Related to Our Business and Industry

    We must attract and retain additional highly skilled employees in order to succeed

  • 48% rewrittenRisks Related to Our Business and Industry

    Our failure to obtain regulatory approval in international jurisdictions would prevent us from marketing our product candidates outside the United States

  • 43% rewrittenRisks Related to Our Business and Industry

    The insurance coverage and reimbursement status of newly approved products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for Revuforj, Niktimvo or any future products could limit our ability to market those products and decrease our ability to generate revenue

  • 31% rewrittenRisks Related to Our Business and Industry

    Social media platforms present new risks and challenges to our business

    Was: Social media platforms and AI-based platforms present new risks and challenges to our business

  • 30% rewrittenRisks Related to Our Business and Industry

    Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of our product candidates

  • 25% rewrittenRisks Related to Ownership of Our Common Stock and Other General Matters

    We may sell additional equity or debt securities or enter into other arrangements to fund our operations, which may result in dilution to our stockholders and impose restrictions or limitations on our business

  • 24% rewrittenRisks Related to Intellectual Property

    We may become involved in lawsuits to protect or enforce our intellectual property, which could be expensive, time-consuming and unsuccessful and have an adverse effect on the success of our business and on our stock price

All 67 risk factors

Headings as the filing states them, in filing order.

Other

  1. 01Summary of Selected Risks72% rewritten
  2. 02We are currently developing several product candidates. If we are unable to successfully complete clinical development of, obtain regulatory approval for, and commercialize our product candidates, our business prospects may be significantly harmedNew
  3. 03Failure to comply with regulatory requirements or unanticipated problems with Revuforj or Niktimvo may result in various adverse actions such as the suspension or withdrawal of Revuforj or Niktimvo, closure of a facility or enforcement of substantial penalties or finesNew
  4. 04Revuforj, Niktimvo and our future products may not achieve adequate market acceptance among physicians, patients, healthcare payors and others in the medical community to be commercially successful93% rewritten
  5. 05Our products and product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial scope of their approved use, or result in significant negative consequences following any marketing approval
  6. 06While we have product, collaboration and milestone revenue, we may never achieve or maintain profitabilityNew
  7. 07The market price of our stock may be volatile and you could lose all or part of your investment100% rewritten

Risks Related to Our Business and Industry

  1. 08our ability to maintain, enforce, and defend third party challenges to our intellectual property rights in and to Revuforj and NiktimvoNew
  2. 09We have recently begun commercialization efforts and the sales, marketing, and distribution of Revuforj, Niktimvo, or any future approved products may be unsuccessful or less successful than anticipatedNew
  3. 10If the market opportunities for our products are smaller than we believe they are, our revenue may be adversely affected, and our business may sufferNew
  4. 11our ability to negotiate preferential formulary status for our product candidates77% rewritten
  5. 12We are currently developing several product candidates. If we are unable to successfully complete clinical development of, obtain regulatory approval for, and commercialize our product candidates, our business prospects will be significantly harmed99% rewritten
  6. 13Interim top-line and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data
  7. 14We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of any of our product candidates
  8. 15We are subject to numerous risks related to the Incyte Collaboration Agreement to collaborate on the development and commercialization of axatilimab
  9. 16We may be required to relinquish important rights to and control over the development and commercialization of our product candidates to our current or future collaborators
  10. 17We may explore strategic collaborations that may never materialize or may fail
  11. 18Failure to comply with regulatory requirements or unanticipated problems with Revuforj or Niktimvo may result in various adverse actions, such as the suspension or withdrawal of either product, closure of a facility or enforcement of substantial penalties or fines
  12. 19The regulatory approval processes of the FDA and foreign regulatory authorities are lengthy, time-consuming and inherently unpredictable. Our inability to obtain regulatory approval for our product candidates would harm our businessNew
  13. 20changes in the approval policies or regulations that render our preclinical and clinical data insufficient for approval58% rewritten
  14. 21Disruptions at the FDA and other government agencies caused by layoffs, funding shortages or global health concerns could negatively impact our businessNew
  15. 22unfavorable publicity relating to our productsNew
  16. 23We are in the process of building and maintaining our sales, marketing and distribution infrastructureNew
  17. 24our direct or indirect sales and marketing efforts may not be successful; and
  18. 25The insurance coverage and reimbursement status of newly approved products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for Revuforj, Niktimvo or any future products could limit our ability to market those products and decrease our ability to generate revenue43% rewritten
  19. 26We currently rely, and expect to continue to rely, on third-party contract manufacturers as well as Incyte for all of our required raw materials, active pharmaceutical ingredients and finished product for our preclinical research, clinical trials, and commercial manufacturing and distributionNew
  20. 27The occurrence of any event or penalty described above may inhibit our ability to commercialize and generate revenue from the sale of our product candidates
  21. 28our reputation may suffer
  22. 29Our failure to obtain regulatory approval in international jurisdictions would prevent us from marketing our product candidates outside the United States48% rewritten
  23. 30We are dependent on UCB Biopharma Sprl, or UCB, to comply with the terms of our license agreement for axatilimab
  24. 31Our employees, consultants and collaborators may engage in misconduct or other improper activities, including insider trading and non-compliance with regulatory standards and requirements
  25. 32We must attract and retain additional highly skilled employees in order to succeed57% rewritten
  26. 33for healthcare products and services, which could result in reduced demand for our products or additional pricing pressuresNew
  27. 34Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of our product candidates30% rewritten
  28. 35the inability to commercialize any products that we may develop
  29. 36Off-label use or misuse of our products may harm our reputation in the marketplace or result in injuries that lead to costly product liability suits
  30. 37Our data processing activities subject us to numerous data privacy and security obligations, such as various laws, regulations, guidance, industry standards, external and internal privacy and security policies, contractual requirements, and other obligations relating to data privacy and security84% rewritten
  31. 38consumer health data (including imposing stringent requirements for consents), provides consumers certain rights with respect to their health data, and creates a private right of action to allow individuals to sue for violations of the law. Other states have proposed, enacted or are considering similar lawsNew
  32. 39Social media platforms present new risks and challenges to our business31% rewritten

Risks Related to Our Financial Position and Capital Needs

  1. 40We have incurred net losses since our inception, except 2021, and anticipate that we will continue to incur net losses for the near future57% rewritten
  2. 41While we have product revenue, we may never achieve or maintain profitability100% rewritten
  3. 42attract, hire and retain additional qualified personnel
  4. 43We may require additional capital to finance our planned operations, which may not be available to us on acceptable terms, or at all. As a result, we may not complete the development and commercialization of, or obtain regulatory approval for our existing product candidates or develop new product candidates
  5. 44If we need to conduct additional fundraising activities and we do not raise additional capital in sufficient amounts or on terms acceptable to us, we may be unable to pursue development and commercialization efforts, which will harm our business, operating results and prospects
  6. 45Changes in tax laws or regulations could materially adversely affect our company95% rewritten
  7. 46Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited

Risks Related to Intellectual Property

  1. 47If we are unable to obtain or protect intellectual property rights, we may not be able to compete effectively in our market
  2. 48We may not be able to protect our intellectual property rights throughout the world71% rewritten
  3. 49and our and our licensors’ patents or other intellectual property rights may not be effective or sufficient to prevent them from competingNew
  4. 50If we breach the UCB license agreement related to axatilimab or if the UCB license agreement is otherwise terminated, we could lose the ability to continue the development and commercialization of axatilimab
  5. 51If we breach the license agreement related to revumenib or if the license agreement is otherwise terminated, we could lose the ability to continue the development and commercialization of revumenib
  6. 52Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidates
  7. 53Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
  8. 54We may become involved in lawsuits to protect or enforce our intellectual property, which could be expensive, time-consuming and unsuccessful and have an adverse effect on the success of our business and on our stock price24% rewritten
  9. 55We may be subject to claims by third parties asserting that we or our employees have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property
  10. 56In addition, for some of our in-licensed patents and patent applications, we do not have access to every patent assignment or employee agreement demonstrating that all inventors have assigned their rights to the inventions or related patents. As a result, we may be subject to claims of ownership by such inventors
  11. 57Our inability to protect our confidential information and trade secrets would harm our business and competitive position

Risks Related to Ownership of Our Common Stock and Other General Matters

  1. 58The market price of our stock may be volatile and you could lose all or part of your investment100% rewritten
  2. 59general economic, industry, political and market conditions, including, but not limited to new or ongoing public health crises and the war between Russia and Ukraine as well as the ongoing conflicts in the Middle East
  3. 60Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and share price
  4. 61We may sell additional equity or debt securities or enter into other arrangements to fund our operations, which may result in dilution to our stockholders and impose restrictions or limitations on our business25% rewritten
  5. 62In addition, we have a significant number of stock options and pre-funded warrants outstanding. To the extent that these have been or may be exercised, stockholders may experience further dilution
  6. 63If securities or industry analysts do not publish research or reports about our business, or if they issue an adverse or misleading opinion regarding our stock, our stock price and trading volume could decline
  7. 64Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant influence control over matters subject to stockholder approval
  8. 65We may be subject to securities litigation, which is expensive and could divert management attention
  9. 66If we fail to maintain an effective system of internal control over financial reporting in the future, we may not be able to accurately report our financial condition, results of operations or cash flows, which may adversely affect investor confidence in us and, as a result, the value of our common stock
  10. 67Some provisions of our charter documents and Delaware law may have anti-takeover effects that could discourage an acquisition of us by others, even if an acquisition would benefit our stockholders and may prevent attempts by our stockholders to replace or remove our current management

Other Syndax Pharmaceuticals 10-Ks

  • FY2024 10-K risk factors
    64 risks

    Syndax relies heavily on the commercial success of newly approved drugs Revuforj and Niktimvo.

    Filed Mar 03, 2025

About this page

The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.