Syndax Pharmaceuticals focuses on developing therapies for cancer. Its work centers on researching, testing through clinical trials, and commercializing cancer drugs, with an emphasis on difficult-to-treat cancers such as HR+ HER2- breast cancer. The company’s lead asset is Entinostat, which is being studied in combination with Exemestane for HR+ HER2- breast cancer; results from these trials will influence its growth and market position. Syndax funds its R&D and operations through capital raises and potential licensing or partnerships, and generates revenue by selling approved medicines. Its goal is to bring new cancer treatments to patients who have limited options by advancing promising oncology therapies and securing successful regulatory approvals and partnerships to scale those therapies.
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Company Size
201-500
Company Stage
IPO
Headquarters
Waltham, MA
Founded
2005
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Syndax highlights acceptance of 19 Revuforj(R)(revumenib) and Niktimvo(TM)(axatilimab-csfr) abstracts, including 7 for Oral Presentation, at ASH 2026. - 14 accepted revumenib abstracts, including 7 for oral presentation, reinforce Syndax's scientific leadership in menin inhibition - - Revumenib abstracts highlight encouraging activity across multiple acute leukemia subtypes and settings, including frontline, post-transplant maintenance, and MRD relapse - - Real-world data showcase compelling results in R/R NPM1m or KMT2Ar acute leukemia patients who received revumenib monotherapy or combination therapy - - 5 accepted axatilimab abstracts, including long-term data that highlight the potential for prolonged clinical benefit with axatilimab in R/R cGVHD - - Company to host investor event and webcast on Monday, December 14, 2026, at 7:00 a.m. CT/8:00 a.m. ET - NEW YORK, Nov. 04, 2026 (GLOBE NEWSWIRE) - Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, today announced the acceptance of multiple Revuforj(R)(revumenib) and Niktimvo(TM)(axatilimab-csfr) abstracts for presentation at the 68th American Society of Hematology (ASH) Annual Meeting taking place in New Orleans, Louisiana, from December 12-15, 2026. A total of nineteen abstracts were accepted, including seven revumenib abstracts accepted for oral presentation. "The breadth of data accepted for presentation at ASH highlights our scientific leadership in menin and CSF-1R inhibition and deep commitment to advancing the standard of care for menin-dependent acute leukemias and chronic GVHD," said Nick Botwood, MBBS, Head of Research & Development and Chief Medical Officer at Syndax. "Across fourteen revumenib abstracts, including seven oral presentations, we will highlight the growing body of clinical trial and real-world data showing compelling revumenib activity spanning the acute leukemia treatment continuum and multiple genetic subtypes." Dr. Botwood continued, "We particularly look forward to the presentation of updated frontline data from the BEAT AML, SAVE, and 708 trials showing high rates of remission, MRD negativity, and encouraging survival among patients treated with revumenib in combination with standard of care therapies. These results bolster our confidence that the ongoing pivotal frontline trials of revumenib-based combinations could transform outcomes for newly diagnosed NPM1m or KMT2Ar AML." The Company will host an in-person investor event, along with a live webcast, at the ASH Annual Meeting on Monday, December 14, 2026, from 7:00-8:30 a.m. CT / 8:00-9:30 a.m. ET to discuss key data presented at the meeting. The live webcast will be available on 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. Key abstracts accepted for presentation at ASH 2026: Revumenib: * BEAT AML (oral presentation): Updated results from a Phase 1b trial of revumenib in combination with venetoclax and azacitidine in newly diagnosed patients with NPM1-mutated (NPM1m) or KMT2A-rearranged (KMT2Ar) acute myeloid leukemia (AML) * SAVE (oral presentation): Updated results from the newly diagnosed cohort in a Phase 1/2 trial of the all-oral combination of revumenib, venetoclax, and decitabine/cedazuridine in patients with NPM1m, KMT2Ar, or NUP98-rearranged (NUP98r) AML * SNDX-5613-0708 (poster presentation): Updated results from a Phase 1 trial of revumenib in combination with intensive chemotherapy in newly diagnosed patients with NPM1m, KMT2Ar, or NUP98r AML * Pre- and post-transplant data (oral presentation): Characterization of disease response and outcomes among relapsed or refractory (R/R) KMT2Ar, NPM1m, and NUP98r patients in the pivotal Phase 1/2 trial of revumenib who proceeded to a stem cell transplant after receiving revumenib * Post-transplant maintenance data (oral presentation): First results from a Phase 1 multicenter trial evaluating revumenib as maintenance following stem cell transplantation in patients with KMT2Ar or NPM1m acute leukemia * INTERCEPT (oral presentation): Updated results from a Phase 1 trial evaluating revumenib as pre-emptive therapy for measurable residual disease (MRD) or early relapse among patients with NPM1m or KMT2Ar AML * Real-world evidence (two poster presentations): Real-world outcomes from multiple centers using revumenib as monotherapy or in combination therapy for patients with KMT2Ar, NPM1m, or NUP98r acute leukemias Axatilimab: * AGAVE-201 (poster presentation): Updated long-term efficacy, safety, and duration of therapy observed in the pivotal Phase 2 trial of axatilimab in recurrent or refractory chronic graft-versus-host disease (GVHD) The accepted abstracts listed below will be available on the ASH conference website. Copies of the oral and poster presentations will be made available through the 'Pipeline - Publications & Meetings Presentations' section of the Syndax website after the relevant embargoes lift. Full list of abstracts accepted for presentation at ASH 2026 (all times in CT): | Abstract Titles | Presentation Details | | Frontline combinations | / | | Azacitidine, venetoclax, and revumenib in newly diagnosed NPM1-mutated (NPM1m) or KMT2A-rearranged (KMT2Ar) acute myeloid leukemia (AML): final analysis of Beat AML phase 1b study | Oral Presentation Publication Number: 662 Sunday, December 13th Session Time: 4:30-6:00 PM | | Update on the phase II study of the all-oral combination of revumenib (SNDX-5613) with decitabine/cedazuridine (ASTX727) and venetoclax (SAVE) in newly diagnosed AML | Oral Presentation Publication Number: 904 Monday, December 14th Session Time: 2:45-4:15 PM | | Revumenib + intensive chemotherapy for newly diagnosed acute myeloid leukemia harboring genetic alterations in NPM1, KMT2A, or NUP98: updated phase 1/2 and pharmacokinetic results from SNDX-5613-0708 | Poster Presentation Publication Number: 3406 Sunday, December 13th Session Time: 6:00-8:00 PM | | Pre- and post-transplant data | / | | Revumenib monotherapy enables patients with relapsed/refractory acute leukemia to proceed to hematopoietic stem cell transplant | Oral Presentation Publication Number: 905 Monday, December 14th Session Time: 2:45-4:15 PM | | A multicenter phase 1 trial of revumenib as post-transplant maintenance after allogeneic stem cell transplant in patients with KMT2A-rearranged or NPM1-mutated acute leukemia | Oral Presentation Publication Number: 715 Sunday, December 13th Session Time: 4:30-6:00 PM | | MRD relapse | / | | Revumenib as pre-emptive therapy for measurable residual disease in NPM1 mutated or KMT2A rearranged AML: the ALLG AMLM26 INTERCEPT platform trial | Oral Presentation Publication Number: 388 Saturday, December 12th Session Time: 4:00-5:30 PM | | Real-world evidence | / | | Revumenib in real-world practice for relapsed/refractory acute leukemia: second interim findings from the multicenter ROAR study | Poster Presentation Publication Number: 3403 Sunday, December 13th Session Time: 6:00-8:00 PM | | Real-world outcomes with revumenib across diverse molecular subtypes and treatment settings in acute myeloid leukemia: a single-center experience | Poster Presentation Publication Number: 3424 Sunday, December 13th Session Time: 6:00-8:00 PM | | Relapsed/refractory | / | | Clinical activity of revumenib in relapsed/refractory therapy-related KMT2A-rearranged acute myeloid leukemia | Poster Presentation Publication Number: 1669 Saturday, December 12th Session Time: 5:30-7:30 PM | | Impact of revumenib on transfusion dependence in patients with relapsed/refractory NPM1-mutated acute myeloid leukemia | Poster Presentation Publication Number: 5170 Monday, December 14th Session Time: 6:00-8:00 PM | | Clinical pharmacology | / | | Exposure-response analysis and quantitative systems pharmacology modeling for recommended phase 3 dose selection of revumenib in newly diagnosed AML | Poster Presentation Publication Number: 3408 Sunday, December 13th Session Time: 6:00-8:00 PM | | Pipeline programs & preclinical data | / | | Phase Ib/II study of revumenib as monotherapy or in combination with JAK inhibitors in patients with myelofibrosis | Poster Presentation Publication Number: 5557 Monday, December 14th Session Time: 6:00-8:00 PM | | Differential drug responses to menin inhibitors in KMT2A-rearranged ALL and AML | Oral Presentation Publication Number: 47 Saturday, December 12th Session Time: 9:30-11:00 AM | | Beyond MEN1: mutations in KMT2A and LEDGF drive cross-resistance to menin inhibitors in preclinical models | Oral Presentation Publication Number: 760 Monday, December 14th Session Time: 10:30 AM-12:00 PM | Axatilimab | Abstract Titles | Presentation Details | | Long-term efficacy and safety of axatilimab among patients with chronic graft-versus-host disease in AGAVE-201 | Poster Presentation Publication Number: 5995 Monday, December 14th Session Time: 6:00-8:00 PM | | Axatilimab demonstrated clinical benefit without baseline corticosteroid use in patients with chronic graft-versus-host-disease: a subgroup analysis of the AGAVE-201 study | Poster Presentation Publication Number: 2478 Saturday, December 12th Session Time: 5:30-7:30 PM | | Immune reprogramming with axatilimab: CSF-1R-dependent myeloid modulation and reduced CD4[+] T-cell activation in chronic graft-versus-host disease | Poster Presentation Publication Number: 6012 Monday, December 14th Session Time: 6:00-8:00 PM | | Molecular signatures associated with clinical improvement in patients with chronic graft-versus-host disease receiving axatilimab: a correlation analysis from AGAVE-201 | Poster Presentation Publication Number: 4252 Sunday, December 13th Session Time: 6:00-8:00 PM | | Assessments of bone mineral density in patients with chronic graft-versus-host disease treated with axatilimab in AGAVE-201 | Online publication only | About Revuforj(R)(revumenib) Revuforj (revumenib) is the first and only menin inhibitor that is FDA approved for the treatment of adult and pediatric patients one year and older with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible NPM1 mutation who have no satisfactory alternative treatment options or R/R acute leukemia with a KMT2A translocation as determined by an FDA-authorized test. Multiple trials of revumenib are underway across the acute leukemia treatment continuum, including in combination with standard of care therapies in newly diagnosed patients with NPM1m or KMT2Ar AML. About Niktimvo(TM)(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. 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. Niktimvo (axatilimab-csfr) IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS Infusion-Related Reactions Niktimvo(TM)(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. About Syndax Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company advancing innovative cancer therapies. Highlights of the Company's pipeline include Revuforj(R)(revumenib), an FDA-approved menin inhibitor, and Niktimvo(TM)(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. [email protected] Tel 781.684.9827
Biotech movers november 4, 2026: LYEL +43% on $80M financing; SNDX -27% ahead of ASH update. BPC UPDATE 11/04/2026 ET TL;DR - Biotech movers: november 4, 2026. * Lyell Immunopharma (LYEL): Raised $80M in a private placement, extending runway into 2028 through expected mid-2027 ronde-cel pivotal data and a planned 2H 2027 BLA. * Guided Therapeutics (GTHP): Surpassed 250 of 800 planned patients in its Turkish LuViva cervical cancer study, with final results expected in coming months. * Syndax Pharmaceuticals (SNDX): Scheduled a December 14 ASH investor briefing focused on hematology updates, but disclosed no new clinical data with the announcement. * BioVie (BIVI): Raised $4.74M through a registered direct offering of 2.96M shares plus an equal number of warrants, increasing dilution and warrant overhang. * Kura Oncology (KURA): Will present initial ziftomenib plus FLT3 inhibitor data and longer-term frontline combination results at ASH 2026. * LivaNova (LIVN): Q3 revenue reached $393.1M with adjusted EPS of $1.23, prompting higher full-year 2026 revenue and EPS guidance. * Oncolytics Biotech (ONCY): Early pelareorep combination data showed immune activation and T-cell expansion in anal cancer, though the dataset remains small and exploratory. Biotech updates. Lyell Immunopharma (NASDAQ: LYEL) secured $80 million through a private placement, stretching operational runway into 2028 to support ronde-cel past pivotal LBCL results anticipated in mid-2027 and an intended 2H 2027 BLA filing. While the capital infusion mitigates immediate balance sheet vulnerability before critical clinical milestones, the transaction imposes equity dilution, keeping overall returns anchored to trial execution success. Shares closed up 43% at $15.43. Guided Therapeutics (OTCQB: GTHP) surpassed 250 enrolled patients out of an 800-patient target in its Turkish Ministry of Health-sponsored LuViva cervical cancer trial, with final readout anticipated in upcoming months. While the trial paves the path toward a prospective national screening initiative covering up to 20 million women each year, commercial realization remains tied to full trial completion and ensuing state integration. Shares closed down 28% at $0.11. LivaNova (NASDAQ: LIVN) delivered third-quarter revenue of $393.1 million, representing a 10% increase on a constant-currency basis, alongside adjusted EPS of $1.23 and $55.8 million in adjusted free cash flow. This performance was primarily propelled by double-digit expansion across its Neuromodulation and Cardiopulmonary segments. Backed by added growth visibility from expanded oxygenator manufacturing capacity and upcoming Category I CPT codes for sleep apnea treatment, the business raised its full-year 2026 outlook for both revenue and EPS. Shares closed up 18% at $94.19. Syndax Pharmaceuticals (NASDAQ: SNDX) scheduled an investor briefing for December 14 during the ASH conference to highlight hematology updates alongside leadership and key opinion leaders. While the update organizes market engagement, near-term stock performance remains tied to the clinical strength of the presented data rather than the presentation event itself. Shares closed down 27% at $10.45. BioVie (NASDAQ: BIVI) executed a registered direct offering totaling $4.74 million at $1.60 per share, issuing 2.96 million common shares paired with warrants to acquire an additional 2.96 million shares at an exercise price of $1.70. While the financing bolsters general working capital, the transaction introduces share dilution and ongoing warrant overhang, adding pressure to the capital structure prior to upcoming clinical milestones. Shares closed down 23% at $1.34. Kura Oncology (NASDAQ: KURA) plans to reveal preliminary clinical results for ziftomenib in combination with FLT3 inhibitors during the ASH 2026 conference, along with mature frontline venetoclax/azacitidine outcomes backing its Phase 3 KOMET-017 trial. While the scientific event offers significant clinical exposure across various AML indication settings, market appreciation remains contingent upon demonstrating robust response depth, clinical durability, and safety across combination cohorts. Shares closed down 23% at $7.61. Oncolytics Biotech (NASDAQ: ONCY) presented Phase 1/2 translational results evaluating pelareorep alongside checkpoint inhibition for previously treated squamous cell anal carcinoma. The data highlighted greater than two-fold elevations in immune activation markers across 7 of 8 patients, alongside tumor-infiltrating lymphocyte clone expansion in all four evaluable subjects who achieved clinical responses, including two complete responses. Additionally, 6 of 14 patients demonstrated HPV-16-specific T-cell expansion, with four showing targeted tumor reduction. While the readout supports strategic partnering and continued advancement, small cohort sizes and early biomarker evaluations leave ultimate therapeutic efficacy tied to broader controlled studies. Shares closed up 9% at $0.42.
Syndax Pharmaceuticals (SNDX) reported third quarter 2026 revenue of $83.3 million and a net loss of $49.43 million from continuing operations. The results missed expectations, and the company also announced a chief financial officer transition. The share price fell 25.57% over the past month and 31.34% over 90 days. It closed at $13.10, against a fair value of $37.27 in the most followed analyst narrative, which implies the stock is 65% undervalued. Syndax guides to about $400 million in 2026 research and development plus selling, general and administrative spending. It holds $575 million in cash, equivalents and investments, and management says it is funded through profitability. Risks include a failed idiopathic pulmonary fibrosis trial and a securities law investigation.
Syndax Pharmaceuticals reported third-quarter revenue of $83.3 million, up 82% from a year earlier, as sales of its leukemia drug Revuforj and collaboration revenue from Niktimvo kept rising. Revuforj net revenue was $60.7 million, up 90% year over year. Niktimvo collaboration revenue was $22.6 million, from net sales of $67 million. Prescriptions for Revuforj rose 13% from the previous quarter to about 1,700. Chief executive officer Michael Metzger said the company is moving toward profitability while still investing in sales and clinical work. Syndax ended the quarter with $551 million in cash, cash equivalents and investments. Chief financial officer Keith Goldan will retire. Aaron Ondrey takes over on November 9.
What Syndax Pharmaceuticals (SNDX) said on its Q3 earnings call. Syndax Pharmaceuticals (NASDAQ:SNDX) reported third-quarter 2026 total revenue of $83.3 million, an 82% increase from the prior-year period, as sales of its Revuforj leukemia treatment and collaboration revenue from Niktimvo continued to rise. Revuforj net revenue reached $60.7 million during the quarter, up 90% year over year and 11% sequentially. Niktimvo collaboration revenue was $22.6 million. Chief Executive Officer Michael Metzger said the company is moving toward profitability while continuing to invest in commercial expansion and clinical development. Revuforj growth driven by new patients and post-transplant use. Chief Commercial Officer Steve Closter said Revuforj prescriptions totaled approximately 1,700 in the third quarter, a 13% sequential increase and roughly double the level of a year earlier. The company added about 300 new patients, representing approximately 20% quarter-over-quarter growth in new starts. Revuforj is approved for relapsed or refractory acute leukemia involving NPM1 or KMT2A alterations. Syndax said it expects the medicine to account for more than 80% of menin inhibitor class revenue for the quarter and described it as the market leader across age groups. About half of new Revuforj patients during the quarter were NPM1 patients, according to the company. Syndax estimated that NPM1 use accounted for more than 35% of Revuforj's third-quarter net revenue, compared with more than 30% in the preceding quarter. Management highlighted increasing use of Revuforj before and after stem cell transplant. Syndax said approximately 40% of its NPM1 patients were proceeding to transplant, with about half subsequently resuming therapy. Among KMT2A patients, approximately 50% proceeded to transplant and about 60% resumed treatment afterward. Metzger characterized transplant-related pauses in therapy as a near-term revenue headwind but a longer-term benefit as more patients return to treatment in the post-transplant setting. He said the company expects the impact of this patient "stack" to become more meaningful in 2027. Patients receiving Revuforj after transplant have averaged at least nine months of therapy so far, while patients not receiving transplants but remaining on treatment have averaged more than seven months, Closter said. Syndax expects more KMT2A patients to resume treatment following transplant over time. The company said more than 620 accounts have ordered Revuforj, up about 8% from the previous quarter. More than 90% of targeted tier 1 and tier 2 accounts have ordered the drug, and formulary coverage is in place for nearly all covered lives in both approved indications. Niktimvo revenue and frontline studies. Niktimvo net revenue was $67 million in the third quarter, up 47% from a year earlier and 12% sequentially. Syndax receives 50% of Niktimvo net profit through its collaboration arrangement, resulting in $22.6 million of collaboration revenue during the quarter. The treatment, which is used in chronic graft-versus-host disease, added more than 300 new patients in the quarter, with approximately 6,350 infusions administered. Syndax said Niktimvo has captured about one-third of the third-line-plus chronic GVHD market and is seeing increased use in third-line treatment. Chief Financial Officer Keith Goldan said Niktimvo's margin contribution was approximately 34% in the quarter, aided slightly by a one-time, nonrecurring adjustment. Going forward, the company expects the contribution margin to remain in the low- to mid-30% range, above its previous expectation of 25% to 30%. In research and development, Syndax now expects to report top-line results from a phase II study of axatilimab, the active ingredient in Niktimvo, in combination with ruxolitinib for newly diagnosed chronic GVHD at a medical meeting in the first quarter of 2027. The company had previously expected the results earlier, but said the revised timing would allow for a more mature dataset including event-free survival. Top-line results from a phase III trial pairing axatilimab with corticosteroids are expected in early 2028. Upcoming leukemia data and pipeline plans. Syndax plans to present several Revuforj datasets during the fourth quarter, including at the American Society of Hematology annual meeting in December. The presentations are expected to include frontline combination data from the BEAT AML and SAVE studies, updates from a frontline trial with intensive chemotherapy, post-transplant data and real-world evidence. Head of R&D and Chief Medical Officer Nick Botwood said updated BEAT AML and SAVE results will feature longer follow-up and larger patient cohorts than prior presentations. The company said earlier data from those studies showed response rates approaching 90% and complete minimal residual disease negativity among responders by flow cytometry. Syndax is also advancing two pivotal frontline AML trials. EVOLVE-2, in patients unfit for intensive chemotherapy, has dual primary endpoints of complete response and overall survival. REVEAL, in patients eligible for intensive chemotherapy, has dual primary endpoints of minimal residual disease-negative complete response and event-free survival. Management did not provide enrollment-completion timelines for either study. Beyond its marketed medicines, Syndax expects to submit an investigational new drug application for SNDX-4321, a mutant-selective allosteric EGFR inhibitor for non-small cell lung cancer, by the end of 2026. It expects SNDX-62122, a next-generation menin inhibitor for myelofibrosis, to enter clinical development next year. A separate phase I/II proof-of-principle trial of revumenib in myelofibrosis is expected to begin in the fourth quarter, with initial data anticipated in the second half of 2027. Cash position and CFO transition. Syndax ended the third quarter with $551 million in cash, cash equivalents and investments. The company maintained its 2026 guidance for combined research and development and selling, general and administrative expenses of approximately $400 million, excluding an estimated $50 million in non-cash stock-based compensation. Goldan said the company believes its cash resources and rising revenue from its two marketed medicines are sufficient to support its commercial and research priorities. The company also announced that Goldan will retire after more than four years as CFO. Aaron Ondrey is scheduled to become CFO effective Nov. 9. Goldan said his decision was personal and that he plans to spend more time with family, pursue hobbies and undertake philanthropic work. About Syndax Pharmaceuticals (NASDAQ:SNDX). Syndax Pharmaceuticals, Inc (NASDAQ:SNDX) is a biopharmaceutical company focused on developing and commercializing therapies for cancer and immune-related diseases. Founded in 2005 and headquartered in Waltham, Massachusetts, the company develops medicines designed to address genetically defined cancers and serious complications associated with cancer treatment. Syndax's lead product is Revuforj (revumenib), an oral menin inhibitor approved in the United States for the treatment of relapsed or refractory acute leukemia with a KMT2A translocation in eligible adults and children.
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Industries
Company Size
201-500
Company Stage
IPO
Headquarters
Waltham, MA
Founded
2005
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