SNDX 8-K
Syndax Pharmaceuticals Inc (SNDX)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On January 12, 2026, Syndax Pharmaceuticals, Inc. (the “Company”) issued a press release in connection with the Company’s presentation on the same date at the 44th Annual J.P. Morgan Healthcare Conference that contains certain preliminary financial information as of and for the fiscal year ended December 31, 2025. Specifically, the press release states that (i) the Company achieved approximately $44 million and $125 million in preliminary (unaudited) U.S. net product revenue for Revuforj® (revumenib) for fiscal quarter and year ended December 31, 2025, respectively, (ii) Niktimvo™ (axatilimab-csfr) achieved $56 million and $152 million in preliminary (unaudited) U.S. net product revenue for fiscal quarter and year ended December 31, 2025, respectively, and the Company will report it’s share of net commercial profit when it reports full year 2025 results, and (iii) the Company’s total preliminary cash, cash equivalents and marketable securities (unaudited) was approximately $394 million as of December 31, 2025.
The information in this Item 2.02 is unaudited and preliminary, and does not present all information necessary for an understanding of the Company’s results of operations for the fiscal year ended December 31, 2025, or financial condition as of December 31, 2025. The preliminary selected financial results reported by the Company for the fourth quarter and full-year 2025 are provided only as an approximation in advance of the Company’s announcement of complete financial results in early 2026. This information is based on currently available information. The audit of the Company’s financial statements for the year ended December 31, 2025 is ongoing and could result in changes to the information in this Item 2.02.
Item 7.01 Regulation FD Disclosure.
The disclosure in Item 2.02 above is hereby incorporated by reference into this Item 7.01.
The information contained in Item 2.02 and 7.01, as well as Exhibit 99.1, to this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit
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Description
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99.1 |
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104 |
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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SYNDAX PHARMACEUTICALS, INC. |
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Date: |
January 12, 2026 |
By: |
/s/ Michael A. Metzger |
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Michael A. Metzger |
Exhibit 99.1
Syndax Reports Preliminary 2025 Financial Highlights and Provides Business Updates at the 44th Annual J.P. Morgan Healthcare Conference
NEW YORK, January 12, 2026 (GLOBE NEWSWIRE) – Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, today announced preliminary, unaudited fourth quarter and full year 2025 financial results and provided additional business updates ahead of its presentation at the 44th Annual J.P. Morgan Healthcare conference.
“2025 was a transformational year for Syndax as we secured our third FDA approval and successfully executed the launches of Revuforj and Niktimvo, proving our ability to deliver innovative therapies for patients and advancing the company towards profitability,” said Michael A. Metzger, Chief Executive Officer of Syndax. “With strong momentum and further acceleration of growth going into 2026, we look forward to continuing to build Revuforj and Niktimvo into industry leading franchises and advancing our lifecycle and frontline programs designed to expand our patient impact and unlock the multi-billion-dollar potential of both medicines.”
Preliminary 2025 Financial Highlights & Recent Business Updates
Revuforj® (revumenib)
Niktimvo™ (axatilimab-csfr)
Cash Position & 2026 Financial Guidance
*The preliminary fourth quarter and full year 2025 financial results are preliminary, unaudited, subject to adjustment, and provided as an approximation in advance of the Company’s announcement of complete financial results in early 2026.
Key 2026 Priorities & Anticipated Milestones
J.P. Morgan Healthcare Conference Presentation and Webcast
Michael Metzger, Chief Executive Officer of Syndax, will discuss these updates as part of a webcast presentation at the 44th Annual J.P. Morgan Healthcare Conference on Monday, January 12, 2026, at 3:00 p.m. PT/ 6:00 p.m. ET. A live webcast of the event can be accessed from the Investor section of the Company's website at www.syndax.com, where a replay of the event will also be available for a limited time.
About Revuforj® (revumenib)
Revuforj (revumenib) is an oral, first-in-class menin inhibitor that is FDA approved for the treatment of relapsed or refractory (R/R) acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation as determined by an FDA-authorized test in adult and pediatric patients one year and older. Revuforj is also indicated for the treatment of R/R acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation in adult and pediatric patients one year and older who have no satisfactory alternative treatment options.
Multiple trials of revumenib are ongoing or planned across the treatment landscape, including in combination with standard of care therapies in newly diagnosed patients with NPM1m or KMT2Ar AML.
Revumenib was previously granted Orphan Drug Designation for the treatment of AML, ALL and acute leukemias of ambiguous lineage (ALAL) by the U.S. FDA and for the treatment of AML by the European Commission. The U.S. FDA also granted Fast Track designation to revumenib for the treatment of adult and pediatric patients with R/R acute leukemias harboring a KMT2A rearrangement or NPM1 mutation and Breakthrough Therapy Designation for the treatment of adult and pediatric patients with R/R acute leukemia harboring a KMT2A rearrangement.
About Niktimvo™ (axatilimab-csfr)
Niktimvo (axatilimab-csfr) is a first-in-class colony stimulating factor-1 receptor (CSF-1R)-blocking antibody approved for use in the U.S. for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs).
In 2016, Syndax licensed exclusive worldwide rights to develop and commercialize axatilimab from UCB. In September 2021, Syndax and Incyte entered into an exclusive worldwide co-development and co-commercialization license agreement for axatilimab in chronic GVHD and any future indications.
Axatilimab is being studied in frontline combination trials in chronic GVHD – a Phase 2 combination trial with ruxolitinib (NCT06388564) and a Phase 3 combination trial with steroids (NCT06585774) are underway. Axatilimab is also being studied in an ongoing Phase 2 trial in patients with idiopathic pulmonary fibrosis (NCT06132256).
About Syndax
Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company advancing innovative cancer therapies. Highlights of the Company's pipeline include Revuforj® (revumenib), an FDA-approved menin inhibitor, and Niktimvo™ (axatilimab-csfr), an FDA-approved monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor. Fueled by our commitment to reimagining cancer care, Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment. For more information, please visit www.syndax.com/ or follow the Company on X and LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, relating to our business, operations, and financial conditions, including but not limited to our preliminary financial results for the fourth quarter and full year 2025 for both Revuforj and Niktimvo, preliminary year-end 2025 cash, cash equivalents, restricted cash and marketable securities, current beliefs, as well as expectations and assumptions regarding the future of our business, future plans and strategies, our
development and commercialization plans. Words such as "anticipate," "believe," "could," "estimate," "expects," "intend," "may," "plan," "potential," "predict," "project," "should," "will," "would" or the negative or plural of those terms, and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Syndax's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the progress, timing, clinical development and scope of clinical trials, the reporting of clinical data for Syndax's product candidates, the acceptance of Syndax and its partners' products in the marketplace, sales, marketing, manufacturing and distribution requirements, and the potential use of its product candidates to treat various cancer indications and fibrotic diseases. Many factors may cause differences between current expectations and actual results, including: unexpected safety or efficacy data observed during preclinical or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; changes to Revuforj's or Niktimvo’s commercial availability; changes in expected or existing competition; changes in the regulatory environment; failure of Syndax's collaborators to support or advance collaborations or product candidates; and unexpected litigation or other disputes. Other factors that may cause Syndax's actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Syndax's filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein. Except as required by law, Syndax assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
Niktimvo is a trademark of Incyte.
All other trademarks are the property of their respective owners.
Contact
Sharon Klahre
Syndax Pharmaceuticals, Inc.
[email protected]
Tel 781.684.9827
SNDX-G