Syndax Reports Preliminary 2025 Financial Highlights and Provides Business Updates at the 44th Annual J.P. Morgan Healthcare Conference

Rhea-AI Summary

Syndax (Nasdaq: SNDX) reported preliminary, unaudited 4Q25 and full‑year 2025 results and business updates ahead of its J.P. Morgan presentation on Jan 12, 2026.

Key figures: preliminary Revuforj net revenue of $44M in 4Q25 and $125M for 2025, Revuforj net revenue up ~38% in 4Q25 vs 3Q25; preliminary Niktimvo net revenue of $56M in 4Q25 and $152M for 2025. Year‑end cash and marketable securities approx. $394M. 2026 expense outlook: R&D plus SG&A ~$400M (ex‑$50M stock comp). Several Phase 2/3 trials and access programs planned for 2026.

Positive

• Revuforj 4Q25 net revenue of $44M
• Revuforj 2025 net revenue of $125M
• Revuforj net revenue +38% in 4Q25 vs 3Q25
• Niktimvo 4Q25 net revenue of $56M
• Niktimvo 2025 net revenue of $152M
• Year‑end cash and marketable securities of approx. $394M

Negative

• Preliminary 4Q25 and full‑year results are unaudited and subject to adjustment
• Guided 2026 R&D plus SG&A of approx. $400M
• Syndax reports only ~25–30% share of Niktimvo net revenue as product contribution

News Market Reaction

-1.33%

7 alerts

-1.33% News Effect

-11.8% Trough in 26 hr 26 min

-$25M Valuation Impact

$1.83B Market Cap

0.1x Rel. Volume

On the day this news was published, SNDX declined 1.33%, reflecting a mild negative market reaction. Argus tracked a trough of -11.8% from its starting point during tracking. Our momentum scanner triggered 7 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $25M from the company's valuation, bringing the market cap to $1.83B at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Revuforj 4Q25 net revenue: $44 million Revuforj FY25 net revenue: $125 million Revuforj 4Q25 growth: 38% +5 more

8 metrics

Revuforj 4Q25 net revenue $44 million Preliminary, unaudited 4Q25 net revenue

Revuforj FY25 net revenue $125 million Preliminary, unaudited full-year 2025 net revenue

Revuforj 4Q25 growth 38% Approximate net revenue increase vs. 3Q25

Revuforj Rx growth 35% Approximate prescription increase 4Q25 vs. 3Q25

Niktimvo 4Q25 net revenue $56 million Preliminary, unaudited 4Q25 net revenue

Niktimvo FY25 net revenue $152 million Preliminary, unaudited full-year 2025 net revenue

Year-end 2025 cash $394 million Preliminary cash, cash equivalents and marketable securities

2026 opex guidance $400 million Expected 2026 R&D plus SG&A, excluding $50M non-cash stock comp

Market Reality Check

Price: $20.25 Vol: Volume 1,025,497 is below...

normal vol

$20.25 Last Close

Volume Volume 1,025,497 is below the 1,354,750 share 20-day average (relative volume 0.76x). normal

Technical Shares at $21.00 are trading above the $14.08 200-day moving average and 7.61% below the 52-week high.

Peers on Argus

SNDX fell 1.82% while peers showed mixed moves: ARDX +6.1%, BHVN -5.12%, VRDN +2...

SNDX fell 1.82% while peers showed mixed moves: ARDX +6.1%, BHVN -5.12%, VRDN +2.85%, VERA +0.23%, TRML 0%. This points to a stock-specific reaction rather than a broad biotech move.

Historical Context

5 past events · Latest: Jan 07 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 07	Access program launch	Positive	+8.7%	Managed Access Program to expand Revuforj availability outside the U.S.
Jan 05	Conference presentation	Neutral	-5.1%	Announcement of JPM Healthcare Conference presentation webcast details.
Dec 12	Award recognition	Positive	-0.2%	Revuforj named Best New Drug at Scrip Awards 2025 after dual approvals.
Dec 08	Clinical data update	Positive	-1.7%	Multiple ASH 2025 presentations showing strong Revuforj efficacy across settings.
Dec 03	Equity inducement grants	Neutral	+0.2%	Inducement stock option grants to a new employee under 2023 plan.

Pattern Detected

Recent positive clinical and access milestones have sometimes led to flat or negative next-day moves, though the managed access program news saw a strong gain, indicating inconsistent alignment between upbeat news and price reaction.

Recent Company History

Over the last few months, SNDX has highlighted expanding access and validation for Revuforj and its menin program. A managed access program announcement on Jan 7, 2026 coincided with a +8.7% move, while a simple JPM conference notice on Jan 5, 2026 saw a -5.07% reaction. Earlier, Revuforj’s ‘Best New Drug’ recognition and extensive ASH 2025 data in Dec 2025 drew slightly negative or flat trading. Routine inducement grants on Dec 3, 2025 had minimal impact. Today’s preliminary 2025 results and guidance fit into this pattern of significant fundamental progress with mixed price responses.

Market Pulse Summary

This announcement details substantial 2025 revenue contributions from Revuforj and Niktimvo, with pr...

Analysis

This announcement details substantial 2025 revenue contributions from Revuforj and Niktimvo, with preliminary net revenues of $44M and $56M in 4Q25 and a year-end cash balance of $394M. It also outlines a $400M 2026 operating expense plan and multiple Phase 2 and Phase 3 programs. Investors may focus on execution across frontline trials, timing of key data readouts, and whether revenue growth can support the company’s stated goal of reaching profitability.

Key Terms

phase 3, randomized, double-blind, placebo-controlled, measurable residual disease, event free survival, +4 more

8 terms

phase 3 medical

"Initiated REVEAL-ND, a Phase 3, randomized, double-blind, placebo-controlled trial"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

randomized, double-blind, placebo-controlled medical

"Phase 3, randomized, double-blind, placebo-controlled trial of revumenib"

A "randomized, double-blind, placebo-controlled" process is a method used to test the effectiveness of a new treatment or intervention. Participants are randomly assigned to different groups, with one receiving the real treatment and the other a fake version, called a placebo. Neither the participants nor the researchers know who is receiving which, which helps ensure unbiased results. For investors, this rigorous approach increases confidence that the findings are accurate and not influenced by guesswork or bias.

measurable residual disease medical

"dual primary endpoints of measurable residual disease (MRD) negative complete remission"

Measurable residual disease (MRD) is the tiny number of cancer cells that remain in a patient after treatment and can be detected using sensitive laboratory tests even when scans look clear. For investors, MRD matters because it's a strong early signal of how well a therapy works, can influence clinical trial success, regulatory decisions and future sales, and helps predict whether disease will come back much like spotting embers after a put-out fire.

event free survival medical

"dual primary endpoints of ... complete remission (CR) and event free survival (EFS)"

A clinical trial measure that tracks how long patients live without a predefined bad outcome—such as the disease getting worse, a return of the disease, or death—after starting a treatment. Investors watch it because longer event‑free survival suggests the treatment is providing meaningful benefit, which can boost likelihood of regulatory approval, payer coverage, and commercial success; think of it like how long a repaired car runs without needing another fix, signaling reliability and value.

idiopathic pulmonary fibrosis medical

"MAXPIRe Phase 2 trial of axatilimab in idiopathic pulmonary fibrosis (IPF)"

Idiopathic pulmonary fibrosis is a chronic lung disease in which the air‑carrying tissue becomes progressively thickened and scarred for no identifiable reason, making the lungs stiff and less able to move oxygen—similar to a sponge that hardens and loses its pores. It matters to investors because it is life‑limiting with limited effective treatments, so clinical trial outcomes, regulatory approvals, pricing and reimbursement decisions can strongly affect the commercial value of therapies and the financial prospects of companies developing treatments.

menin inhibition medical

"Further leadership in menin and CSF-1R inhibition through the publication"

Menin inhibition is a drug approach that blocks the activity of menin, a protein that helps certain cancer cells turn on genes that drive their growth. Stopping menin is like removing a key assistant that hands a bully its megaphone—it can silence the gene programs tumors rely on, slowing or shrinking disease. For investors, menin inhibitors matter because they represent a targeted therapy strategy whose clinical trial results and regulatory decisions can strongly affect company value and market opportunity.

csf-1r inhibition medical

"Further leadership in menin and CSF-1R inhibition through the publication"

CSF-1R inhibition is the blocking of the colony-stimulating factor 1 receptor, a protein on certain immune cells that tells them to grow, survive and move; inhibiting it is like turning down a signal that recruits and fuels those cells. It matters to investors because drugs using this approach aim to slow tumor-supporting or inflammation-driving cells, offering potential new treatments and revenue streams while carrying typical clinical, regulatory and market risks.

post-hsct maintenance medical

"including revumenib data from the frontline and post-HSCT maintenance setting"

Post-HSCT maintenance is ongoing medical treatment given after a patient receives a hematopoietic stem cell transplant to lower the chance the original disease returns and to support the new immune system. Think of it like routine tune-ups after a major engine overhaul: smaller, regular interventions that can extend the transplant’s benefit and reduce complications. Investors watch this because it creates demand for prolonged therapies, affects trial success rates, and influences long‑term safety and revenue profiles.

AI-generated analysis. Not financial advice.

 – Approximately $44 million and $125 million in preliminary (unaudited) Revuforj^® (revumenib) 4Q25 and full year 2025 net revenue, respectively –

 – Continued acceleration in demand following approval in R/R NPM1m AML, with an approximate 38% increase in Revuforj net revenue in 4Q25 vs. 3Q25 -

 – $56 million and $152 million in preliminary (unaudited) Niktimvo™ (axatilimab-csfr) 4Q25 and full year 2025 net revenue, respectively; Syndax will report its share of the Niktimvo net profit when it reports full year 2025 results –

 – Ended 2025 with approximately $394 million in cash, cash equivalents and marketable securities (unaudited); fully funded through profitability –

 – Syndax to present at the 44^th Annual J.P. Morgan Healthcare Conference on Monday, January 12, 2026, at 3:00 p.m. PT/ 6:00 p.m. ET. –

NEW YORK, Jan. 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 44^th 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)

• Approximately $44 million and $125 million in preliminary (unaudited) fourth quarter and full-year 2025 Revuforj net revenue, respectively. Revuforj net revenue increased by approximately 38% in the fourth quarter of 2025 compared to the third quarter of 2025. The Company observed continued acceleration in demand following the FDA’s approval of Revuforj in R/R NPM1m AML on October 24, 2025, with an approximately 35% increase in total Revuforj prescriptions in the fourth quarter of 2025 compared to the third quarter 2025.
• Received the ‘Best New Drug’ award for Revuforj at the Scrip Awards 2025. The award recognizes excellence in pharmaceutical development and the drug that represents the best therapeutic advance in its area.
• Initiated REVEAL-ND, a Phase 3, randomized, double-blind, placebo-controlled trial of revumenib in combination with intensive chemotherapy in newly diagnosed patients with NPM1m AML in November 2025. The trial has dual primary endpoints of measurable residual disease (MRD) negative complete remission (CR) and event free survival (EFS) to support the potential for accelerated approval and full approval, respectively.
• Initiated a multi-regional Managed Access Program which will expand access to Revuforj outside the U.S. This program enables physicians to prescribe Revuforj to appropriate patients outside the U.S. where the drug is not approved but access to novel medicines is permitted by local regulations and where funding can be secured.
  
  

Niktimvo™ (axatilimab-csfr)

• $56 million and $152 million in preliminary (unaudited) fourth quarter and full-year 2025 Niktimvo net revenue, respectively. Syndax will report its 50% share of the Niktimvo net commercial profit, defined as net product revenue minus the cost of sales and commercial expenses, when the Company reports its full year 2025 results. The Company expects its share of the product contribution to amount to approximately 25-30% of Niktimvo net revenue.
  
  

Cash Position & 2026 Financial Guidance

• Preliminary (unaudited) year-end 2025 cash, cash equivalents, and marketable securities of approximately $394 million.
• For the full year of 2026, the Company expects total research and development plus selling, general and administrative expenses to be approximately $400 million, excluding the impact of $50 million in estimated non-cash stock compensation expense.
• Syndax expects that its cash position, combined with its anticipated product revenue, interest income, and stable operating expense base, will enable the company to reach profitability.
  
  

*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

• Drive Revuforj and Niktimvo net revenue growth and invest thoughtfully in pipeline development and data generation to fuel further growth.
• Complete enrollment in MAXPIRe Phase 2 trial of axatilimab in idiopathic pulmonary fibrosis (IPF) in January 2026, with topline data on track for the second half of 2026.
• Advance global enrollment in EVOLVE-2 (unfit NPM1m and KMT2Ar AML) and REVEAL-ND (fit NPM1m), two Phase 3 frontline trials of revumenib in combination with low-intensity and high-intensity regimens, respectively.
• Initiate RAVEN, a Phase 2 collaborative trial of revumenib in combination with venetoclax and azacitidine in newly diagnosed KMT2Ar patients who would be considered eligible, or fit, for intensive chemotherapy in 2026.
• Further leadership in menin and CSF-1R inhibition through the publication and presentation of clinical trial data and real-world evidence, including revumenib data from the frontline and post-HSCT maintenance setting.
• Initiate a program in 2026 designed to generate proof-of-principle clinical data with revumenib in myelofibrosis (MF).
  
  

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.
sklahre@syndax.com
Tel 781.684.9827

SNDX-G

FAQ

What were Syndax (SNDX) preliminary Revuforj revenues for 4Q25 and 2025?

Preliminary Revuforj net revenue was approx. $44M in 4Q25 and $125M for full‑year 2025.

How much did Revuforj sales grow in 4Q25 versus 3Q25 for SNDX?

Revuforj net revenue increased by approximately 38% in 4Q25 versus 3Q25.

What preliminary revenue did Syndax report for Niktimvo in 2025 (SNDX)?

Preliminary Niktimvo net revenue was approx. $56M in 4Q25 and $152M for 2025.

What is Syndax's cash position at year‑end 2025 and runway claim (SNDX)?

Year‑end cash, cash equivalents and marketable securities were approx. $394M, and the company said it is fully funded through profitability.

What 2026 operating expense guidance did Syndax (SNDX) give?

Syndax expects R&D plus SG&A of about $400M in 2026, excluding an estimated $50M non‑cash stock compensation impact.

When will Syndax present at the 44th J.P. Morgan Healthcare Conference (SNDX)?

Syndax will present on Jan 12, 2026 at 3:00 p.m. PT / 6:00 p.m. ET, with a live webcast and limited‑time replay available.