Syndax Announces Topline Results from MAXPIRe Phase 2 Trial of Axatilimab in Idiopathic Pulmonary Fibrosis

Rates of treatment-emergent adverse events leading to treatment discontinuation were low in both MAXPIRe trial arms.

Rhea-AI Summary

Syndax Pharmaceuticals (SNDX) announced that its MAXPIRe Phase 2 trial of axatilimab in idiopathic pulmonary fibrosis failed its primary endpoint. The endpoint measured the annualized decline in forced vital capacity (FVC), a measure of how much air a person can forcibly exhale. Syndax does not plan further development of axatilimab in this lung disease.

The 145-patient, 26-week trial compared axatilimab with placebo. The annualized 52-week FVC rate was derived from measurements collected over 26 weeks. Safety and tolerability were comparable to placebo, with no new safety signals or treatment-related fatal adverse events in either arm.

The results do not affect ongoing trials in other potential indications. Axatilimab remains in frontline combination trials for chronic graft-versus-host disease (cGVHD), including combinations with ruxolitinib and steroids. Syndax expects cGVHD trial results later in 2026 and early 2028.

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1 major · 2 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Minor pointMAXPIRe safety and tolerability were comparable to placebo, with no new safety signals observed.
• Minor pointTreatment discontinuations from treatment-emergent adverse events were low in both MAXPIRe arms.
• Minor pointNo treatment-related fatal adverse events occurred in either MAXPIRe arm.
• Minor pointOther axatilimab trials are unaffected by the MAXPIRe results.
• Minor pointFrontline cGVHD development continues in Phase 2 with ruxolitinib and Phase 3 with steroids.
• Minor point. Forward-looking: it has not happened yet and may not happen.cGVHD trial results are expected by Syndax later in 2026 and early 2028.

Negative

• Major pointMAXPIRe Phase 2 did not meet its primary endpoint of annualized decline in forced vital capacity.
• Minor point. Forward-looking: it has not happened yet and may not happen.Further axatilimab development in IPF is not planned by Syndax following the trial results.

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Key Figures

Trial enrollment: 145 patients Trial duration: 26 weeks Randomization: 2:1 +1 more

Trial enrollment

145 patients

MAXPIRe Phase 2 trial

Trial duration

26 weeks

MAXPIRe trial

Randomization

2:1

Axatilimab versus placebo

Axatilimab dose

0.3 mg/kg

Administered every two weeks in MAXPIRe

Key Terms

idiopathic pulmonary fibrosis, forced vital capacity, treatment-emergent adverse events, linear mixed effects model

4 terms

idiopathic pulmonary fibrosis medical

"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.

forced vital capacity medical

"annualized rate of decline in forced vital capacity (FVC)"

The amount of air a person can forcefully breathe out after taking the deepest breath possible; think of it as how much air you can squeeze out of a balloon in one hard blow. It matters to investors because it’s a common, objective measure used in clinical trials and patient monitoring for respiratory drugs, devices and treatments—changes in this number can signal whether a therapy works, affecting regulatory approval, sales and company value.

treatment-emergent adverse events medical

"Rates of treatment-emergent adverse events (TEAEs) leading to treatment discontinuation"

Events or symptoms that either appear for the first time or get worse after a patient starts a treatment; think of new or intensified side effects that show up once medicine or a medical device is used. Investors watch these closely because they affect whether a therapy can gain regulatory approval, be prescribed widely, or face legal and commercial setbacks—similar to how early customer complaints can sink a new product’s prospects.

linear mixed effects model technical

"and a linear mixed effects model"

A linear mixed effects model is a statistical regression model that combines fixed effects (variables with a single common effect across the whole dataset) and random effects (terms that allow intercepts and/or slopes to vary across groups or subjects). It is used for data with natural grouping or repeated measurements — for example, multiple observations from the same company, hospital, or person — because the random effects capture correlation within groups while the fixed effects estimate average, population-level relationships; parameters are typically estimated by maximum likelihood or restricted maximum likelihood. The model relies on assumptions such as linear relationships, and that random effects and residuals follow specified distributions (commonly normal), which affects interpretation and validity of results.

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– Trial did not meet the primary endpoint of annualized rate of FVC decline –

– Axatilimab was well tolerated with a safety profile comparable to placebo; no new safety signals were observed –

– Axatilimab continues to advance in multiple trials in cGVHD with results expected later this year and early 2028 –

NEW YORK, Oct. 12, 2026 (GLOBE NEWSWIRE) -- Syndax Pharmaceuticals (Nasdaq: SNDX) today announced that the MAXPIRe Phase 2 trial of axatilimab in idiopathic pulmonary fibrosis (IPF) did not meet its primary endpoint of the annualized rate of decline in forced vital capacity (FVC). The safety and tolerability profile observed in MAXPIRe was consistent with previous clinical studies of axatilimab, with no new safety signals identified. Based on the results observed, Syndax does not plan to move forward with further development of axatilimab in IPF. The results from the MAXPIRe trial do not affect ongoing trials of axatilimab in other potential indications.

“The MAXPIRe trial did not meet its primary endpoint, and we are disappointed by this outcome given the promising scientific rationale in IPF,” said Nick Botwood, MBBS, Head of Research & Development and Chief Medical Officer at Syndax. “We sincerely thank the patients, caregivers, clinicians and study teams who participated. Axatilimab was well tolerated, with a safety profile consistent with prior studies supporting its continued development and use in cGVHD. There are multiple trials underway in cGVHD where axatilimab has shown remarkable results and we look forward to readouts from these trials later this year and in early 2028.”

“We remain highly focused on further advancing revumenib and axatilimab to frontline in the ongoing clinical trials which will unlock significant value for patients and shareholders. And we are well positioned to deliver breakthroughs for patients and build long-term value, with a robust pipeline, multiple upcoming catalysts, and strong financial position,” added Michael A. Metzger, Chief Executive Officer of Syndax. “We look forward to working with our partner Incyte as we continue to build Niktimvo into a blockbuster franchise in cGVHD.”

MAXPIRe was a 26-week, randomized, double-blind, placebo-controlled, multicenter, Phase 2, 145-patient trial which evaluated the efficacy and safety of axatilimab in patients with IPF who were enrolled across 62 sites in 14 countries. Patients were randomized 2:1 to axatilimab 0.3 mg/kg or placebo every two weeks, with randomization stratified according to the use of background antifibrotic therapy. The primary endpoint of the trial was the annualized rate of decline in FVC. The annualized (52-week) rate was derived using FVC measurements collected over a 26-week period.

Axatilimab was well tolerated in patients with IPF with a safety and tolerability profile comparable to placebo and no new safety signals observed. Rates of treatment-emergent adverse events (TEAEs) leading to treatment discontinuation were low in both arms. The most frequent TEAEs in the axatilimab arm were generally consistent with previous studies. There were no treatment-related fatal adverse events in either arm.

Axatilimab is a first-in-class, CSF-1R-blocking monoclonal antibody that is FDA approved for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg. Axatilimab is being studied in combination with standard-of-care therapies in patients with newly diagnosed cGVHD in two ongoing clinical trials.

About the MAXPIRe Trial

The MAXPIRe trial (NCT06132256) was a Phase 2, 26-week, randomized, double-blind, placebo-controlled, multicenter, 145-patient trial which evaluated the efficacy and safety of axatilimab in patients with IPF who were enrolled across 62 sites in 14 countries. Patients were randomized 2:1 to receive axatilimab 0.3 mg/kg or placebo every two weeks, with randomization stratified according to the use of background antifibrotic therapy.

The primary endpoint of the trial was the annualized rate of decline in forced vital capacity (FVC). The annualized (52-week) rate was derived using FVC measurements collected over a 26-week period and a linear mixed effects model. Secondary endpoints included the time to disease progression, annualized rate of decline in percent predicted FVC from baseline, quality-of-life measures, and change in percent predicted diffusion capacity for carbon monoxide from baseline.

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, including a Phase 2 combination trial with ruxolitinib (NCT06388564) and a Phase 3 combination trial with steroids (NCT06585774).

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS
Infusion-Related Reactions
Niktimvo^™ (axatilimab-csfr) can cause infusion-related reactions. Infusion-related reactions, including hypersensitivity reactions, occurred in 18% of patients who received Niktimvo in the clinical trial (AGAVE-201), with Grade 3 or 4 reactions in 1.3%.

Premedicate with an antihistamine and an antipyretic for patients who have previously experienced an infusion-related reaction to Niktimvo. Monitor patients for signs and symptoms of infusion-related reactions, including fever, chills, rash, flushing, dyspnea, and hypertension. Interrupt or slow the rate of infusion or permanently discontinue Niktimvo based on severity of the reaction.

Embryo-Fetal Toxicity
Based on its mechanism of action, Niktimvo may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with Niktimvo and for 30 days after the last dose.

ADVERSE REACTIONS
Serious adverse reactions occurred in 44% of patients who received Niktimvo (N=79). Serious adverse reactions in >2 patients included infection (pathogen unspecified) (14%), viral infection (14%) and respiratory failure (5.1%). Permanent discontinuation of Niktimvo due to an adverse reaction occurred in 10% of patients and dose reduction due to adverse reaction occurred in 8% of patients. Dose interruptions due to an adverse reaction occurred in 44% of patients. The adverse reactions leading to dose interruption in >2 patients were viral infection, infection (pathogen unspecified), bacterial infection, musculoskeletal pain, and pyrexia.

The most common (≥15%) adverse reactions, including laboratory abnormalities, were increased aspartate aminotransferase (AST), infection (pathogen unspecified), increased alanine aminotransferase (ALT), decreased phosphate, decreased hemoglobin, viral infection, increased gamma glutamyl transferase (GGT), musculoskeletal pain, increased lipase, fatigue, increased amylase, increased calcium, increased creatine phosphokinase (CPK), increased alkaline phosphatase (ALP), nausea, headache, diarrhea, cough, bacterial infection, pyrexia, and dyspnea.

Clinically relevant adverse reactions in <10% of patients who received Niktimvo included:

• Eye disorders: periorbital edema
• Skin and subcutaneous skin disorders: pruritus
• Vascular disorders: hypertension
  
  

Immunogenicity: Anti-Drug Antibody–Associated Adverse Reactions
Across treatment arms in patients with cGVHD who received Niktimvo in clinical trials, among the patients who developed anti-drug antibodies (ADAs), hypersensitivity reactions occurred in 26% (13/50) of patients with neutralizing antibodies (NAb) and in 4% (2/45) of those without NAb.

USE IN SPECIFIC POPULATIONS
Lactation
Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment and for 30 days after the last dose of Niktimvo.

Females and Males of Reproductive Potential
Pregnancy Testing
Verify pregnancy status in females of reproductive potential prior to initiating Niktimvo.

Contraception
Females
Advise females of reproductive potential to use effective contraception during treatment with Niktimvo and for 30 days after the last dose of Niktimvo.

DOSAGE AND ADMINISTRATION
Dosage Modifications for Adverse Reactions
Monitor aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), creatine phosphokinase (CPK), amylase, and lipase prior to the start of Niktimvo therapy, every 2 weeks for the first month, and every 1 to 2 months thereafter until abnormalities are resolved. See Table 1 in the Prescribing Information for more recommendations.

Please see the full Prescribing Information for Niktimvo.

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. 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.

Syndax Contact
Sharon Klahre
Syndax Pharmaceuticals, Inc.
sklahre@syndax.com
Tel 781.684.9827

SNDX-G

FAQ

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What did Syndax's MAXPIRe trial of axatilimab in IPF show?

MAXPIRe did not meet its primary endpoint of the annualized rate of decline in forced vital capacity. Safety and tolerability were comparable to placebo, and no new safety signals were observed. There were no treatment-related fatal adverse events in either arm.

Will Syndax continue developing axatilimab for IPF after MAXPIRe?

Syndax does not plan further development of axatilimab in IPF based on the MAXPIRe results. The results do not affect ongoing trials in other potential indications, including chronic graft-versus-host disease.

How were patients assigned treatment in Syndax's MAXPIRe trial?

Patients were randomized 2:1 to receive axatilimab 0.3 mg/kg or placebo every two weeks. Randomization was stratified according to the use of background antifibrotic therapy. The double-blind trial enrolled patients across 62 sites in 14 countries.