Syndax Announces Four Revuforj® (revumenib) Abstracts Accepted for ASCO 2026, Including an Oral Presentation of Post-Transplant Data

Rhea-AI Summary

Syndax (Nasdaq:SNDX) announced that four Revuforj (revumenib) abstracts were accepted for presentation at ASCO 2026, including an oral post-transplant maintenance study in 21 adults and children with acute leukemia.

Additional posters cover revumenib pharmacokinetics and designs of two phase 3 trials in newly diagnosed NPM1m or KMT2Ar AML.

News Market Reaction – SNDX

+0.86%

+0.86% Session close to close

In the May 22 session, SNDX gained 0.86%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement underscores Syndax’s expanding Revuforj data package, with four ASCO 2026 abstract...

Analysis

This announcement underscores Syndax’s expanding Revuforj data package, with four ASCO 2026 abstracts spanning post‑transplant maintenance and detailed pharmacokinetic characterization. The company highlights the ability to dose with gastric acid reducers, CYP3A4 inhibitors, and low‑fat meals, while reiterating boxed warnings for differentiation syndrome, QTc prolongation, and Torsades de Pointes. Investors may watch upcoming ASCO presentations and future trial readouts to assess how these data influence clinical adoption and long‑term safety perceptions.

Key Figures

Post-transplant patients: 21 adults and children Differentiation syndrome incidence: 60 of 241 patients (25%) QTc prolongation incidence: 86 of 241 patients (36%) +5 more

8 metrics

Post-transplant patients 21 adults and children Revumenib maintenance after hematopoietic stem cell transplantation

Differentiation syndrome incidence 60 of 241 patients (25%) Patients treated at recommended revumenib dose in trials

QTc prolongation incidence 86 of 241 patients (36%) QTc interval prolongation reported as adverse reaction

QTcF >500 msec 10% of patients Patients treated with revumenib at recommended dose

Differentiation syndrome onset Median 9 days (range 3–41) Time to initial onset after starting revumenib

Fatal adverse reactions 9 patients (4%) Fatal events among 241 revumenib-treated patients

Pediatric age threshold 1 year and older FDA-approved use for R/R acute leukemia and AML

ASCO 2026 dates May 29 – June 2, 2026 Conference window for revumenib presentations

Historical Context

5 past events · Latest: May 20 (Positive)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
May 20	Investor conferences	Positive	+3.6%	Announcement of participation in several upcoming healthcare investor conferences.
May 12	Clinical abstracts EHA	Positive	-4.5%	Twelve Revuforj abstracts accepted for EHA 2026 across leukemia settings.
May 06	Inducement grants	Negative	-0.5%	Inducement stock options for new employees under the 2023 Inducement Plan.
Apr 30	Q1 2026 earnings	Positive	-10.8%	Q1 2026 results with strong Revuforj and Niktimvo revenue but ongoing net loss.
Apr 24	Earnings date notice	Neutral	+1.9%	Scheduling of Q1 2026 earnings call and webcast details for investors.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

News tied to scientific/medical visibility (conference abstracts, investor events) has produced mixed reactions, with some clinically focused releases selling off despite seemingly constructive content.

Recent Company History

Over the last month, Syndax issued several updates spanning conferences, clinical visibility, and financial results. On Apr 30, first‑quarter 2026 earnings and a business update coincided with a -10.83% move despite strong revenue growth. Subsequent items included an earnings-date notice, inducement option grants, and multiple Revuforj abstract acceptances for EHA 2026, plus participation in investor conferences. This ASCO abstract news continues the pattern of expanding Revuforj data across leukemia settings and raising scientific visibility.

Key Terms

pharmacokinetics, hematopoietic stem cell transplantation, QTc prolongation, torsades de pointes, +4 more

8 terms

pharmacokinetics medical

"A poster presentation characterizing the pharmacokinetics (PK) of revumenib..."

Pharmacokinetics is the study of how a substance, such as a drug or chemical, moves through and is processed by the body over time. It tracks how it is absorbed, distributed, broken down, and eventually eliminated. For investors, understanding pharmacokinetics helps gauge the effectiveness, safety, and potential risks of new medications or treatments, which can influence a company’s success and valuation in the healthcare industry.

hematopoietic stem cell transplantation medical

"revumenib as maintenance following hematopoietic stem cell transplantation (HSCT)."

A procedure that replaces a person’s damaged or diseased blood-forming cells with healthy stem cells so the body can rebuild its blood and immune system; think of it as replanting seeds in a damaged garden so new plants can grow. It matters to investors because the success, supply, cost and regulation of these transplants and related products (donor cells, lab-grown or engineered alternatives, hospital services) can significantly affect the revenues, trial outcomes and valuation of biotech, medical device and healthcare companies.

QTc prolongation medical

"WARNING: DIFFERENTIATION SYNDROME, QTc PROLONGATION, and TORSADES DE POINTES"

QTc prolongation is a lengthening of the heart’s electrical “reset” time between beats, measured on an electrocardiogram and adjusted for heart rate. It matters to investors because prolonged QTc can signal a drug or device safety risk that may lead to regulatory warnings, clinical trial delays, label restrictions, market withdrawals, or higher liability costs—similar to a car whose brakes take longer to reset, increasing the chance of a dangerous failure.

torsades de pointes medical

"QTc prolongation and Torsades de Pointes have occurred in patients..."

Torsades de pointes is a specific, dangerous abnormal heart rhythm where the heart’s electrical signals become erratic and the heartbeat twists in pattern, which can lead to fainting or sudden cardiac arrest. It matters to investors because certain drugs, medical devices, or conditions can trigger this rhythm, prompting regulatory warnings, trial delays, label changes, recalls or lawsuits that can sharply affect a company’s sales, approval prospects and stock price—like a car engine suddenly misfiring and forcing an emergency stop.

differentiation syndrome medical

"Differentiation syndrome, which can be fatal, has occurred with Revuforj."

Differentiation syndrome is a potentially serious treatment reaction that can occur when certain cancer drugs force immature tumor cells to mature quickly, causing widespread inflammation, fluid buildup, breathing problems or organ stress — like a sudden crowd surge that clogs exits and streets. It matters to investors because the risk and management of this side effect can influence clinical trial results, drug approvals, safety labeling, prescribing use and ultimately a therapy’s market value and adoption.

cyp3a4 inhibitors medical

"ensure optimal exposure in the presence of strong CYP3A4 inhibitors..."

CYP3A4 inhibitors are substances that slow or block the activity of CYP3A4, a key liver enzyme that acts like a conveyor belt breaking down many medicines. When that conveyor slows, drugs can stay in the body longer and reach higher levels, which can change a treatment’s safety, dose, or how it’s prescribed; investors watch for these interactions because they affect a drug’s regulatory approval, marketability, and potential liability.

electrocardiogram medical

"Perform an electrocardiogram (ECG) prior to initiation of Revuforj..."

An electrocardiogram (ECG or EKG) is a simple, noninvasive test that records the heart’s electrical signals through sensors on the skin and displays them as a waveform showing heart rate and rhythm. For investors, ECGs are important because they are a primary tool for diagnosing heart conditions, monitoring safety and effectiveness in clinical trials, and driving demand for medical devices and services—like a dashboard gauge revealing whether a car’s engine is healthy.

qtc interval medical

"QTc interval prolongation and Torsades de Pointes have occurred..."

QTc interval is a measure of the time the heart’s electrical system takes to recharge between beats, adjusted for heart rate so the number is comparable across people. Like timing how long a flashlight needs to recharge before the next flash, it flags whether the heart may be vulnerable to dangerous rhythm problems; prolonged QTc readings are a common safety concern in drug testing and can lead to warnings, trial delays, or regulatory actions that matter to investors.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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– Oral presentation will highlight favorable outcomes observed among 21 adults and children with KMT2Ar, NPM1m, or NUP98r acute leukemia who received revumenib post-transplant –

– Data underscoring unique aspects of revumenib’s PK profile, including the ability to administer it with gastric acid reducing agents and low-fat meals, will be presented –

– Design of ongoing pivotal trials of revumenib plus low or high-intensity chemotherapy in newly diagnosed NPM1m or KMT2Ar acute leukemia will be highlighted –

NEW YORK, May 21, 2026 (GLOBE NEWSWIRE) -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, today announced the acceptance of four Revuforj^® (revumenib) abstracts for presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29 – June 2, 2026, in Chicago.

“Our strong presence at ASCO highlights our scientific leadership in menin inhibition and our deep commitment to advancing cancer care. We and our collaborators will present new evidence that moves the field forward, including an oral presentation of data showing favorable outcomes among patients who received revumenib in the post-transplant setting. This presentation will provide additional evidence in an area of high physician interest and inform further clinical research,” said Nick Botwood, MBBS, Head of Research & Development and Chief Medical Officer at Syndax.

Dr. Botwood continued, “Building on the strong body of efficacy data that distinguishes revumenib, we also look forward to presenting PK data which highlight other important aspects of its profile, including the ability to administer revumenib with commonly prescribed gastric acid reducing agents without the risk of reducing efficacy.”

Key revumenib presentations at ASCO 2026:

• An oral presentation of safety and efficacy data from 21 adults and children with KMT2Ar, NPM1m, or NUP98r acute leukemia who received revumenib as maintenance following hematopoietic stem cell transplantation (HSCT). The presentation will include the observed overall survival and relapse rate, along with a comparison to a historical cohort of patients with the same genetic subtypes of acute leukemia treated prior to the advent of revumenib.
• A poster presentation characterizing the pharmacokinetics (PK) of revumenib, with an emphasis on differentiating aspects of its PK profile, including the ability to 1) administer revumenib with gastric acid reducing agents without the risk of reduced efficacy, 2) ensure optimal exposure in the presence of strong CYP3A4 inhibitors using a clear revumenib dose adjustment strategy, and 3) administer revumenib with low-fat meals.

The accepted abstracts listed below are now available online on the ASCO conference website. Copies of the oral and poster presentations will be made available in the ‘Publications & Meeting Presentations’ section of the Syndax website after the data are presented.

Full list of revumenib abstracts accepted for presentation at ASCO 2026 (all times in CDT):

Abstract Titles	Presentation Details
Revumenib as maintenance for AML following allogeneic stem cell transplantation	Abstract number: 6505 Oral presentation Tuesday, June 2, 9:45 am-12:45 pm
Pharmacokinetic (PK) assessment of revumenib in patients with relapsed/refractory (R/R) acute leukemias harboring a KMT2A rearrangement (KMT2Ar) or NPM1 mutation (NPM1m): Impact of food and concomitant medications	Abstract number: 6528 Poster presentation Monday, June 1, 9:00 am – 12:00 pm
A phase 3 study of revumenib plus venetoclax/azacitidine in adults with newly diagnosed NPM1-mutated or KMT2A-rearranged acute myeloid leukemia ineligible for intensive chemotherapy (EVOLVE-2/HO177/AMLSG35-24/ACT-HOV-AML-002): Trial in progress	Abstract number: TPS6600 Poster presentation Monday, June 1, 9:00 am – 12:00 pm
A phase 3 study of revumenib in combination with intensive chemotherapy in patients with newly diagnosed NPM1-mutated acute myeloid leukemia (REVEAL-ND NPM1): Trial in progress	Abstract number: TPS6602 Poster presentation Monday, June 1, 9:00 am – 12:00 pm

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.

Revuforj (revumenib)

IMPORTANT SAFETY INFORMATION

WARNING: DIFFERENTIATION SYNDROME, QTc PROLONGATION, and TORSADES DE POINTES

Differentiation syndrome, which can be fatal, has occurred with Revuforj. Signs and symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, and renal dysfunction. If differentiation syndrome is suspected, immediately initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution.

QTc prolongation and Torsades de Pointes have occurred in patients receiving Revuforj. Correct hypokalemia and hypomagnesemia prior to and during treatment. Do not initiate Revuforj in patients with QTcF > 450 msec. If QTc interval prolongation occurs, interrupt, reduce, or permanently discontinue Revuforj.

WARNINGS AND PRECAUTIONS

Differentiation Syndrome: Revuforj can cause fatal or life-threatening differentiation syndrome (DS). Symptoms of DS, including those seen in patients treated with Revuforj, include fever, dyspnea, hypoxia, peripheral edema, pleuropericardial effusion, acute renal failure, rash, and/or hypotension.

In clinical trials, DS occurred in 60 (25%) of 241 patients treated with Revuforj at the recommended dosage for relapsed or refractory acute leukemia. Among those with a KMT2A translocation, DS occurred in 33% of patients with acute myeloid leukemia (AML), 33% of patients with mixed-phenotype acute leukemia (MPAL), and 9% of patients with acute lymphoblastic leukemia (ALL); DS occurred in 18% of patients with NPM1m AML. DS was Grade 3 or 4 in 12% of patients and fatal in 2 patients. The median time to initial onset was 9 days (range 3-41 days). Some patients experienced more than 1 DS event. Treatment interruption was required for 7% of patients, and treatment was withdrawn for 1%.

Reduce the white blood cell count to less than 25 Gi/L prior to starting Revuforj. If DS is suspected, immediately initiate treatment with systemic corticosteroids (e.g., dexamethasone 10 mg IV every 12 hours in adults or dexamethasone 0.25 mg/kg/dose IV every 12 hours in pediatric patients weighing less than 40 kg) for a minimum of 3 days and until resolution of signs and symptoms. Institute supportive measures and hemodynamic monitoring until improvement. Interrupt Revuforj if severe signs and/or symptoms persist for more than 48 hours after initiation of systemic corticosteroids, or earlier if life-threatening symptoms occur such as pulmonary symptoms requiring ventilator support. Restart steroids promptly if DS recurs after tapering corticosteroids.

QTc Interval Prolongation and Torsades de Pointes: Revuforj can cause QT (QTc) interval prolongation and Torsades de Pointes.

Of the 241 patients treated with Revuforj at the recommended dosage for relapsed or refractory acute leukemia in clinical trials, QTc interval prolongation was reported as an adverse reaction in 86 (36%) patients. QTc interval prolongation was Grade 3 in 15% and Grade 4 in 2%. The heart-rate corrected QT interval (using Fridericia’s method) (QTcF) was greater than 500 msec in 10%, and the increase from baseline QTcF was greater than 60 msec in 24%. Revuforj dose reduction was required for 7% due to QTc interval prolongation. QTc prolongation occurred in 21% of the 34 patients less than 17 years old, 35% of the 146 patients 17 years to less than 65 years old, and 46% of the 61 patients 65 years or older. One patient had a fatal outcome of cardiac arrest, and one patient had non-sustained Torsades de Pointes.

Correct electrolyte abnormalities, including hypokalemia and hypomagnesemia, prior to and throughout treatment with Revuforj. Perform an electrocardiogram (ECG) prior to initiation of Revuforj, and do not initiate Revuforj in patients with QTcF >450 msec. Perform an ECG at least once weekly for the first 4 weeks and at least monthly thereafter. In patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval, more frequent ECG monitoring may be necessary. Concomitant use with drugs known to prolong the QTc interval may increase the risk of QTc interval prolongation.

• Interrupt Revuforj if QTcF increases >480 msec and <500 msec, and restart Revuforj at the same dose twice daily after the QTcF interval returns to ≤480 msec
• Interrupt Revuforj if QTcF increases >500 msec or by >60 msec from baseline, and restart Revuforj twice daily at the lower-dose level after the QTcF interval returns to ≤480 msec
• Permanently discontinue Revuforj in patients with ventricular arrhythmias and in those who develop QTc interval prolongation with signs or symptoms of life-threatening arrhythmia
  

Embryo-Fetal Toxicity: Revuforj can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with Revuforj and for 4 months after the last dose of Revuforj.

ADVERSE REACTIONS

Fatal adverse reactions occurred in 9 (4%) patients who received Revuforj, including 4 with sudden death, 2 with differentiation syndrome, 2 with hemorrhage, and 1 with cardiac arrest.

Serious adverse reactions were reported in 184 (76%) patients. The most frequent serious adverse reactions (≥10%) were infection (29%), febrile neutropenia (20%), bacterial infection (15%), differentiation syndrome (13%), and hemorrhage (11%).

The most common adverse reactions (≥20%) including laboratory abnormalities, were phosphate increased (51%), hemorrhage (48%), nausea (48%), infection without identified pathogen (46%), aspartate aminotransferase increased (44%), alanine aminotransferase increased (40%), creatinine increased (38%), musculoskeletal pain (37%), febrile neutropenia (37%), electrocardiogram QT prolonged (36%), potassium decreased (34%), parathyroid hormone intact increased (34%), alkaline phosphatase increased (33%), diarrhea (29%), bacterial infection (27%), triglycerides increased (27%), phosphate decreased (25%), differentiation syndrome (25%), fatigue (24%), edema (24%), viral infection (23%), decreased appetite (20%), and constipation (20%).

DRUG INTERACTIONS

Drug interactions can occur when Revuforj is concomitantly used with:

• Strong CYP3A4 inhibitors: reduce Revuforj dose
• Strong or moderate CYP3A4 inducers: avoid concomitant use with Revuforj
• QTc-prolonging drugs: avoid concomitant use with Revuforj. If concomitant use is unavoidable, obtain ECGs when initiating, during concomitant use, and as clinically indicated. Withhold Revuforj if the QTc interval is >480 msec. Restart Revuforj after the QTc interval returns to ≤480 msec
  

SPECIFIC POPULATIONS

Lactation: advise lactating women not to breastfeed during treatment with Revuforj and for 1 week after the last dose.  

Pregnancy and testing: Revuforj can cause fetal harm when administered to a pregnant woman. Verify pregnancy status in females of reproductive potential within 7 days prior to initiating Revuforj.

Infertility: based on findings in animals, Revuforj may impair fertility. The effects on fertility were reversible.

Pediatric: monitor bone growth and development in pediatric patients.

Geriatric: no overall differences were observed in the effectiveness of Revuforj between patients who were 65 years and older, and younger patients. Compared to younger patients, the incidences of QTc prolongation and edema were higher in patients 65 years and older.

To report SUSPECTED ADVERSE REACTIONS, contact Syndax Pharmaceuticals at 1-888-539-3REV or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Full Prescribing Information, including BOXED WARNINGS.

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.

Syndax Contact

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

SNDX-G

FAQ

What did Syndax (SNDX) announce about Revuforj at ASCO 2026?

Syndax announced four Revuforj (revumenib) abstracts accepted for ASCO 2026, including one oral and three poster presentations. According to Syndax, these cover post-transplant maintenance data, pharmacokinetics, and phase 3 trial designs in newly diagnosed NPM1m or KMT2Ar acute myeloid leukemia.

What is included in the Revuforj oral presentation at ASCO 2026 for SNDX?

The Revuforj oral presentation will report safety and efficacy in 21 adults and children receiving post-transplant maintenance for genetically defined acute leukemias. According to Syndax, it will include overall survival, relapse rates, and comparison with a historical cohort treated before revumenib became available.

What pharmacokinetic data on Revuforj will Syndax (SNDX) present at ASCO 2026?

Syndax will present a Revuforj pharmacokinetic poster in relapsed or refractory acute leukemias with KMT2A rearrangements or NPM1 mutations. According to Syndax, it examines dosing with gastric acid reducing agents, strong CYP3A4 inhibitors with dose adjustment, and administration alongside low-fat meals.

Which phase 3 Revuforj trials will be highlighted by Syndax (SNDX) at ASCO 2026?

Two phase 3 Revuforj trials will be described as trials in progress at ASCO 2026. According to Syndax, one combines revumenib with venetoclax/azacitidine in newly diagnosed NPM1-mutated or KMT2A-rearranged AML, and another evaluates revumenib plus intensive chemotherapy in newly diagnosed NPM1-mutated AML.

When and where will Syndax present its Revuforj ASCO 2026 abstracts?

Syndax’s Revuforj abstracts will be presented at the ASCO Annual Meeting from May 29 to June 2, 2026, in Chicago. According to Syndax, the oral and poster materials will be posted afterward in the Publications & Meeting Presentations section of its website.