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Syndax Pharmaceuticals

HQ: New York, NY source · syndax.com ↗ · Mid-Atlantic

FDA-approved therapeutic company Clinical Phase 3

Location: New York, NY · source · Aug 4, 2026

Profile checked Oct 10, 2026

Keywords: Acute Myeloid Leukemia Breast Cancer Non-Small-Cell Lung Carcinoma Estrogen Receptor-Positive Breast Cancer Acute Lymphoblastic Leukemia Mixed Phenotype Acute Leukemia Chronic Graft-versus-host-disease Non-Small Cell Lung Cancer ER+ Breast Cancer Glandular and Epithelial Neoplasms Neoplasms by Histologic Type Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Digestive System Neoplasms Endocrine Gland Neoplasms Lung Diseases Breast Diseases Renal Neoplasm Mixed Lineage Acute Leukemia Acute Leukemia of Ambiguous Lineage Colorectal Cancer Idiopathic Pulmonary Fibrosis Relapsed/Refractory Acute Leukemia Melanoma Mismatch Repair-Proficient Colorectal Cancer Acute Leukemia Relapsed/Refractory Leukemias Acute Lymphocytic Leukemia Acute Undifferentiated Leukemia Epithelial Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer Coronavirus

30Trials (company is sponsor)2FDA records (2 yrs)

Timeline

  1. Debt Debt: $250M (not counted as a raise), announced Jun 4, 2026. Source: SEC filing. source ↗
  2. Trial start Phase 3: Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With a NPM1 Mutation source ↗
  3. FDA FDA New indication / efficacy supplement: REVUFORJ (revumenib citrate) — NDA218944/3, Oct 24, 2025. Applicant at approval: Syndax Pharmaceuticals, Inc. source ↗
  4. FDA FDA New drug/biologic (novel): REVUFORJ (revumenib citrate) — NDA218944, Nov 15, 2024. Applicant at approval: Syndax Pharmaceuticals, Inc. source ↗
  5. Trial start Phase 1: A Study of Revumenib in Combination With Intensive Chemotherapy in Participants With Acute Myeloid Leukemias source ↗
  6. Trial start Phase 2: MAXPIRe: Study to Evaluate Axatilimab in Participants With Idiopathic Pulmonary Fibrosis (IPF) source ↗
  7. Trial start Phase 1/Phase 2: Evaluation of Revumenib in Participants With Colorectal Cancer and Other Solid Tumors source ↗
  8. Trial start Phase 1: Study of Radiolabeled Revumenib in Adults With Acute Leukemia source ↗
  9. Trial start Phase 1: A Study of Revumenib in Combination With Chemotherapy in Participants With R/R Acute Leukemia source ↗
  10. Trial start Phase 2: A Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD) source ↗
  11. Trial start 2: A Phase 2 Study to Evaluate Axatilimab for Hospitalized Participants With Respiratory Involvement Secondary to COVID-19 source ↗
  12. Trial start Phase 1/Phase 2: A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation source ↗
  13. Trial start 1: A Phase 1/2 Study to Evaluate Axatilimab in Participants With Active cGVHD source ↗
  14. Trial start 1: A Phase 1 Study to Investigate Axatilimab Alone or in Combination With Durvalumab in Patients With Solid Tumors source ↗
  15. Trial start Phase 1: A Study to Evaluate the Pharmacokinetics of Entinostat in Adult Subjects With Normal and Impaired Renal Function source ↗
  16. Trial start Phase 1: A Study to Examine the Effects of Entinostat on Midazolam in Healthy Adult Subjects source ↗
  17. Trial start Phase 1/Phase 2: Study of Avelumab With or Without Entinostat in Participants With Advanced Epithelial Ovarian Cancer source ↗
  18. Trial start Phase 1: A Study to Examine the Effect of Omeprazole, Famotidine, and an Acidic Beverage on the Pharmacokinetics of Entinostat in Healthy Adult Subjects source ↗
  19. Trial start Phase 1: Study to Determine the Effect of the Timing of a Meal on the Pharmacokinetics of Entinostat source ↗
  20. Trial start Phase 1: Continuation Study of Entinostat in Combination With Pembrolizumab in Patients With Advanced Solid Tumors source ↗
  21. Trial start Phase 1: Cardiac Safety Study of Entinostat in Men and Women With Advanced Solid Tumors source ↗
  22. Trial start Phase 1: Drug-Drug Interaction Study of Entinostat and Exemestane in Postmenopausal Women With ER+ Breast Cancer source ↗
  23. Trial start 2: Randomized Phase 2 Study of Atezolizumab and Entinostat in Patients With aTN Breast Cancer With Phase 1b Lead In source ↗
  24. Trial start Phase 1/Phase 2: Ph1b/2 Dose-Escalation Study of Entinostat With Pembrolizumab in Non-small Cell Lung Cancer (NSCLC) With Expansion Cohorts in NSCLC, Melanoma, and Colorectal Cancer (CRC) source ↗
  25. Trial start 2: Phase 2 Study of Fulvestrant With and Without Entinostat in Postmenopausal Women With ER+ Advanced Breast Cancer source ↗

Showing 25 of 32 dated events.

Upcoming milestones

Estimated primary completion per ClinicalTrials.gov. Dates move.

Funding

Debt: $250.0M. Last 2 years.

Clinical trials (lead sponsor) 30

RecordTitlePhaseStatusStartPrimary completion
NCT04065399A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 MutationPhase 1/Phase 2RecruitingNov 5, 2019Dec 15, 2027 (estimated)
NCT07211958Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With a NPM1 MutationPhase 3RecruitingNov 25, 20252029-06 (estimated)
NCT06226571A Study of Revumenib in Combination With Intensive Chemotherapy in Participants With Acute Myeloid LeukemiasPhase 1Active, not recruitingMay 21, 20242027-02 (estimated)
NCT05731947Evaluation of Revumenib in Participants With Colorectal Cancer and Other Solid TumorsPhase 1/Phase 2TerminatedApr 4, 2023Jun 30, 2025 (actual)
NCT04710576A Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD)Phase 2RecruitingMar 4, 2021Apr 7, 2023 (actual)
NCT06132256MAXPIRe: Study to Evaluate Axatilimab in Participants With Idiopathic Pulmonary Fibrosis (IPF)Phase 2Active, not recruitingDec 11, 20232026-09 (estimated)
NCT03604692A Phase 1/2 Study to Evaluate Axatilimab in Participants With Active cGVHD1CompletedNov 1, 2018Aug 12, 2022 (actual)
NCT05918913Expanded Access Program for RevumenibNot listedNo longer availableNot listedNot listed
NCT02437136Ph1b/2 Dose-Escalation Study of Entinostat With Pembrolizumab in Non-small Cell Lung Cancer (NSCLC) With Expansion Cohorts in NSCLC, Melanoma, and Colorectal Cancer (CRC)Phase 1/Phase 2CompletedAug 26, 2015Sep 29, 2022 (actual)
NCT05406817Study of Radiolabeled Revumenib in Adults With Acute LeukemiaPhase 1CompletedAug 5, 2022Nov 18, 2024 (actual)
NCT02708680Randomized Phase 2 Study of Atezolizumab and Entinostat in Patients With aTN Breast Cancer With Phase 1b Lead In2Completed2016-05Mar 31, 2021 (actual)
NCT05326516A Study of Revumenib in Combination With Chemotherapy in Participants With R/R Acute LeukemiaPhase 1CompletedMar 9, 2022Jul 29, 2024 (actual)
NCT03238027A Phase 1 Study to Investigate Axatilimab Alone or in Combination With Durvalumab in Patients With Solid Tumors1CompletedSep 1, 2017Nov 20, 2020 (actual)
NCT02915523Study of Avelumab With or Without Entinostat in Participants With Advanced Epithelial Ovarian CancerPhase 1/Phase 2CompletedDec 19, 2016Feb 21, 2019 (actual)
NCT00750698A Phase 2 Exploratory Study of Erlotinib and SNDX-275 in Participants With Non-small Cell Lung Carcinoma Who Are Progressing on Erlotinib2Terminated2008-082010-05 (actual)
NCT00602030Study to Evaluate Erlotinib With or Without SNDX-275 (Entinostat) in the Treatment of Patients With Advanced NSCLCPhase 1/Phase 2CompletedJan 8, 2008Feb 4, 2010 (actual)
NCT04415073A Phase 2 Study to Evaluate Axatilimab for Hospitalized Participants With Respiratory Involvement Secondary to COVID-192TerminatedMay 30, 2020Jul 13, 2020 (actual)
NCT00828854Study of the Effect of the Addition of SNDX-275 (Entinostat) to Continued Aromatase Inhibitor (AI) Therapy in Postmenopausal Women With ER+ Breast Cancer Whose Disease is ProgressingPhase 2CompletedOct 1, 2008Nov 24, 2009 (actual)
NCT00754312A Phase I, Multicenter, Open Label Study on the Effects of SNDX-275 on Expression of Biomarkers in Subjects With Newly Diagnosed Breast CancerITerminated2008-06Feb 28, 2009 (actual)
NCT00676663Study to Evaluate Exemestane With and Without Entinostat (SNDX-275) in Treatment of Postmenopausal Women With Advanced Breast CancerPhase 2CompletedJun 13, 2008Jan 29, 2011 (actual)
NCT02897778Cardiac Safety Study of Entinostat in Men and Women With Advanced Solid TumorsPhase 1CompletedAug 24, 2016Mar 13, 2017 (actual)
NCT02909452Continuation Study of Entinostat in Combination With Pembrolizumab in Patients With Advanced Solid TumorsPhase 1CompletedSep 20, 2016Jul 17, 2019 (actual)
NCT02820961Drug-Drug Interaction Study of Entinostat and Exemestane in Postmenopausal Women With ER+ Breast CancerPhase 1CompletedJun 29, 2016Sep 10, 2018 (actual)
NCT01594398Study to Assess Food Effect on Pharmacokinetics of Entinostat in Subjects With Breast Cancer or Non-Small Cell Lung CancerPhase 1Completed2012-052014-04 (actual)
NCT00866333A Phase 2 Multi-Center Study of Entinostat (SNDX-275) in Patient With Relapsed or Refractory Hodgkin's Lymphoma2TerminatedApr 13, 2009Feb 8, 2013 (actual)
NCT02922933A Study to Examine the Effect of Omeprazole, Famotidine, and an Acidic Beverage on the Pharmacokinetics of Entinostat in Healthy Adult SubjectsPhase 1CompletedOct 25, 2016Apr 19, 2017 (actual)
NCT03187015A Study to Examine the Effects of Entinostat on Midazolam in Healthy Adult SubjectsPhase 1CompletedMay 23, 2017Jun 4, 2017 (actual)
NCT02922946Study to Determine the Effect of the Timing of a Meal on the Pharmacokinetics of EntinostatPhase 1CompletedOct 11, 2016May 20, 2017 (actual)
NCT03192111A Study to Evaluate the Pharmacokinetics of Entinostat in Adult Subjects With Normal and Impaired Renal FunctionPhase 1CompletedJul 27, 2017Nov 23, 2017 (actual)
NCT02115594Phase 2 Study of Fulvestrant With and Without Entinostat in Postmenopausal Women With ER+ Advanced Breast Cancer2Withdrawn2014-042015-12 (estimated)

FDA records (last 2 years)

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