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Syndax Pharmaceuticals Inc (SNDX)

Syndax Pharmaceuticals, Inc. operates as a clinical-stage biopharmaceutical firm focused on developing innovative therapies for cancer. Among its leading investigational products are SNDX-5613, currently undergoing Phase 1/2 clinical assessment, which targets the Menin-mixed lineage leukemia 1 protein interaction for treating MLL-rearranged (MLLr) and nucleophosmin 1 mutant acute myeloid leukemia (NPM1c AML). Another significant candidate is SNDX-6352, or axatilimab, a monoclonal antibody designed to block the colony stimulating factor 1 (CSF-1) receptor, intended for patients suffering from chronic graft versus host disease (cGVHD). The company is additionally progressing Entinostat. Syndax has also established strategic collaborations, including a research and development agreement with the National Cancer Institute, a clinical trial agreement with the Eastern Cooperative Oncology Group, and a license agreement with Kyowa Hakko Kirin Co., Ltd. Founded in 2005, Syndax Pharmaceuticals, Inc. maintains its corporate headquarters in Waltham, Massachusetts.

Sector: Pharmaceutical Preparations

Industry: Biotechnology

Syndax Pharmaceuticals, Inc. logo

Syndax Pharmaceuticals, Inc.

NASDAQ:SNDXHealthcare
-3.53%$13.65
AH$13.65+0.00%vs close
Mkt Cap$1.22B
Float84.21M
O/S89.3M
Vol
$ Vol
RVOL
Inst Own-
SI21.4%
Earnings
Dilution
Syndax Pharmaceuticals, Inc. logoNASDAQ:SNDX$13.65-3.53%
Phase Distribution
30 lead-sponsored trials·5 active·18 completed
Phase 113
Phase 1/27
Phase 28
Phase 31
Not applicable1
(23 more as collaborator)
Status Overview
Recruiting3
Active, not recruiting2
Completed18
Stopped6
Expanded access1

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials
Sponsor role
Status
Phase
  • Phase 3
    Recruiting

    Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With a NPM1 Mutation

    Revumenib, Placebo

    Acute Myeloid Leukemias

    Enrollment
    468
    Start
    Nov 2025
    Primary Completion
    Jun 2029est.
    Completion
    Jan 2031est.
    NCT07211958
  • Phase 2
    Completed

    Study to Evaluate Exemestane With and Without Entinostat (SNDX-275) in Treatment of Postmenopausal Women With Advanced Breast Cancer

    entinostat, exemestane

    Breast Cancer, Estrogen Receptor-Positive Breast Cancer +2

    Enrollment
    130
    Start
    Jun 2008
    Primary Completion
    Jan 2011
    Completion
    Nov 2012
    NCT00676663
  • Phase 2
    Terminated

    A Phase 2 Exploratory Study of Erlotinib and SNDX-275 in Participants With Non-small Cell Lung Carcinoma Who Are Progressing on Erlotinib

    Entinostat, Erlotinib

    Non Small Cell Lung Cancer

    Enrollment
    8
    Start
    Aug 2008
    Primary Completion
    May 2010
    Completion
    Jun 2010
    NCT00750698
  • Phase 2
    Completed

    Study 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 Progressing

    Entinostat, Aromatase Inhibitor (AI) Therapy

    ER+ Breast Cancer

    Enrollment
    27
    Start
    Oct 2008
    Primary Completion
    Nov 2009
    Completion
    Nov 2009
    NCT00828854
  • Phase 2
    Terminated

    A Phase 2 Multi-Center Study of Entinostat (SNDX-275) in Patient With Relapsed or Refractory Hodgkin's Lymphoma

    Entinostat

    Hodgkin's Lymphoma

    Enrollment
    49
    Start
    Apr 2009
    Primary Completion
    Feb 2013
    Completion
    Feb 2013
    NCT00866333
  • Phase 2
    Withdrawn

    Phase 2 Study of Fulvestrant With and Without Entinostat in Postmenopausal Women With ER+ Advanced Breast Cancer

    Fulvestrant, Entinostat

    Breast Cancer

    Enrollment
    0
    Start
    Apr 2014
    Primary Completion
    Dec 2015est.
    Completion
    Jun 2016est.
    NCT02115594
  • Phase 2
    Terminated

    A Phase 2 Study to Evaluate Axatilimab for Hospitalized Participants With Respiratory Involvement Secondary to COVID-19

    SNDX-6352, Placebo

    Coronavirus, COVID +3

    Enrollment
    1
    Start
    May 2020
    Primary Completion
    Jul 2020
    Completion
    Jul 2020
    NCT04415073
  • Phase 2
    Recruiting

    A Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD)

    Axatilimab

    Chronic Graft-versus-host-disease

    Enrollment
    296
    Start
    Mar 2021
    Primary Completion
    Apr 2023
    Completion
    Sep 2027est.
    NCT04710576
  • Phase 2
    Active, not recruiting

    MAXPIRe: Study to Evaluate Axatilimab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

    Axatilimab

    Idiopathic Pulmonary Fibrosis

    Enrollment
    145
    Start
    Dec 2023
    Primary Completion
    Sep 2026est.
    Completion
    Nov 2026est.
    NCT06132256
  • Phase 1/2
    Completed

    Study to Evaluate Erlotinib With or Without SNDX-275 (Entinostat) in the Treatment of Patients With Advanced NSCLC

    Entinostat, Placebo

    Non-Small-Cell Lung Carcinoma, Carcinoma, Non-Small Cell Lung

    Enrollment
    141
    Start
    Jan 2008
    Primary Completion
    Feb 2010
    Completion
    Feb 2012
    NCT00602030
  • Phase 1/2
    Completed

    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)

    entinostat, pembrolizumab

    Non-Small Cell Lung Cancer, Melanoma +1

    Enrollment
    191
    Start
    Aug 2015
    Primary Completion
    Sep 2022
    Completion
    Sep 2022
    NCT02437136
  • Phase 1/2
    Completed

    Randomized Phase 2 Study of Atezolizumab and Entinostat in Patients With aTN Breast Cancer With Phase 1b Lead In

    Entinostat, Atezolizumab

    Breast Cancer

    Enrollment
    89
    Start
    May 2016
    Primary Completion
    Mar 2021
    Completion
    Mar 2021
    NCT02708680
  • Phase 1/2
    Completed

    Study of Avelumab With or Without Entinostat in Participants With Advanced Epithelial Ovarian Cancer

    entinostat, avelumab

    Epithelial Ovarian Cancer, Peritoneal Cancer +1

    Enrollment
    140
    Start
    Dec 2016
    Primary Completion
    Feb 2019
    Completion
    Apr 2021
    NCT02915523
  • Phase 1/2
    Completed

    A Phase 1/2 Study to Evaluate Axatilimab in Participants With Active cGVHD

    axatilimab

    Chronic Graft-versus-host-disease

    Enrollment
    41
    Start
    Nov 2018
    Primary Completion
    Aug 2022
    Completion
    Oct 2024
    NCT03604692
  • Phase 1/2
    Recruiting

    A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

    revumenib, cobicistat

    Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia +3

    Enrollment
    447
    Start
    Nov 2019
    Primary Completion
    Dec 2027est.
    Completion
    Dec 2027est.
    NCT04065399
  • Phase 1/2
    Terminated

    Evaluation of Revumenib in Participants With Colorectal Cancer and Other Solid Tumors

    Revumenib, Chemotherapy

    Colorectal Cancer, Solid Tumors

    Enrollment
    41
    Start
    Apr 2023
    Primary Completion
    Jun 2025
    Completion
    Jun 2025
    NCT05731947
  • Phase 1
    Terminated

    A Phase I, Multicenter, Open Label Study on the Effects of SNDX-275 on Expression of Biomarkers in Subjects With Newly Diagnosed Breast Cancer

    SNDX-275

    Breast Cancer

    Enrollment
    1
    Start
    Jun 2008
    Primary Completion
    Feb 2009
    Completion
    Feb 2009
    NCT00754312
  • Phase 1
    Completed

    Study to Assess Food Effect on Pharmacokinetics of Entinostat in Subjects With Breast Cancer or Non-Small Cell Lung Cancer

    entinostat, entinostat

    Lung Cancer, Non Small Cell Lung Cancer (NSCLC) +2

    Enrollment
    14
    Start
    May 2012
    Primary Completion
    Apr 2014
    Completion
    May 2014
    NCT01594398
  • Phase 1
    Completed

    Drug-Drug Interaction Study of Entinostat and Exemestane in Postmenopausal Women With ER+ Breast Cancer

    entinostat, exemestane

    Breast Cancer, Estrogen Receptor Positive Breast Cancer

    Enrollment
    61
    Start
    Jun 2016
    Primary Completion
    Sep 2018
    Completion
    Jul 2021
    NCT02820961
  • Phase 1
    Completed

    Cardiac Safety Study of Entinostat in Men and Women With Advanced Solid Tumors

    Entinostat, Placebo

    Neoplasms, Neoplasms, Glandular and Epithelial +13

    Enrollment
    30
    Start
    Aug 2016
    Primary Completion
    Mar 2017
    Completion
    Mar 2017
    NCT02897778
  • Phase 1
    Completed

    Continuation Study of Entinostat in Combination With Pembrolizumab in Patients With Advanced Solid Tumors

    Entinostat, Pembrolizumab

    Neoplasms, Neoplasms, Glandular and Epithelial +12

    Enrollment
    30
    Start
    Sep 2016
    Primary Completion
    Jul 2019
    Completion
    Feb 2021
    NCT02909452
  • Phase 1
    Completed

    A Study to Examine the Effect of Omeprazole, Famotidine, and an Acidic Beverage on the Pharmacokinetics of Entinostat in Healthy Adult Subjects

    entinostat

    Volunteers, Healthy Volunteers +2

    Enrollment
    66
    Start
    Oct 2016
    Primary Completion
    Apr 2017
    Completion
    May 2017
    NCT02922933
  • Phase 1
    Completed

    Study to Determine the Effect of the Timing of a Meal on the Pharmacokinetics of Entinostat

    Entinostat

    Volunteers, Healthy Volunteers +2

    Enrollment
    47
    Start
    Oct 2016
    Primary Completion
    May 2017
    Completion
    Jun 2017
    NCT02922946
  • Phase 1
    Completed

    A Study to Examine the Effects of Entinostat on Midazolam in Healthy Adult Subjects

    Entinostat, Midazolam

    Drug Interaction, Healthy Volunteer

    Enrollment
    26
    Start
    May 2017
    Primary Completion
    Jun 2017
    Completion
    Aug 2017
    NCT03187015
  • Phase 1
    Completed

    A Study to Evaluate the Pharmacokinetics of Entinostat in Adult Subjects With Normal and Impaired Renal Function

    Entinostat

    Renal Impairment, Healthy Volunteer

    Enrollment
    40
    Start
    Jul 2017
    Primary Completion
    Nov 2017
    Completion
    Nov 2017
    NCT03192111

1-25 of 30

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