MedPath

Syndax Pharmaceuticals

🇺🇸United States
Ownership
-
Employees
184
Market Cap
$1.7B
Website
Introduction

Syndax Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company engaged in the development of cancer therapies. Its product candidates include SNDX-5613 and SNDX-6352. The company was founded by Richard A. Heyman, Eckard Weber, Peter Ordentlich, Ronald M. Evans and Michael Downes on October 11, 2005 and is headquartered in Waltham, MA.

Clinical Trials

34

Active:6
Completed:18

Trial Phases

3 Phases

Phase 1:20
Phase 2:8
Not Applicable:2

Drug Approvals

0

Drug Approvals

No drug approvals found

This company may not have drug approvals in our database

Clinical Trials

Distribution across different clinical trial phases (30 trials with phase data)• Click on a phase to view related trials

Phase 1
20 (66.7%)
Phase 2
8 (26.7%)
Not Applicable
2 (6.7%)

Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed KMT2Ar or NUP98r AML (REVEAL-ND KMT2A)

Not Applicable
Not yet recruiting
Conditions
Acute Myeloid Leukemia
Interventions
Drug: Intensive Chemotherapy Regimen
Drug: Placebo
First Posted Date
2025-10-08
Last Posted Date
2025-10-08
Lead Sponsor
Syndax Pharmaceuticals
Target Recruit Count
235
Registration Number
NCT07212023

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

Not Applicable
Not yet recruiting
Conditions
Acute Myeloid Leukemias
Interventions
Drug: Placebo
Drug: Intensive Chemotherapy Regimen
First Posted Date
2025-10-08
Last Posted Date
2025-10-08
Lead Sponsor
Syndax Pharmaceuticals
Target Recruit Count
468
Registration Number
NCT07211958

Phase 1 Study of SNDX-5613 in Combination with Intensive Chemotherapy in Participants with AML Harboring Alterations in KMT2A/MLL, NPM1, or NUP98 Genes

Phase 1
Recruiting
Conditions
Acute Myeloid Leukemias
Interventions
Drug: Chemotherapy Regimen
Drug: HiDAC
First Posted Date
2024-01-26
Last Posted Date
2025-07-24
Lead Sponsor
Syndax Pharmaceuticals Inc.
Target Recruit Count
22
Registration Number
2024-514531-18-00
Locations
🇺🇸

UCLA Medical Hematology, Burbank, California, United States

🇺🇸

City of Hope Medical Center, Duarte, California, United States

🇺🇸

AdventHealth Blood & Marrow Transplant Center, Orlando, Florida, United States

and more 34 locations

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

Phase 2
Recruiting
Conditions
Idiopathic Pulmonary Fibrosis
Interventions
Other: Placebo
First Posted Date
2023-11-15
Last Posted Date
2025-08-22
Lead Sponsor
Syndax Pharmaceuticals
Target Recruit Count
135
Registration Number
NCT06132256
Locations
🇨🇳

National Taiwan University Hospital, Taipei city, Taiwan

🇦🇺

Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

🇦🇺

Sunshine Coast University Hospital, Birtinya, Queensland, Australia

and more 71 locations

Expanded Access Program for Revumenib

Conditions
Relapsed/Refractory Acute Leukemia
First Posted Date
2023-06-26
Last Posted Date
2025-09-05
Lead Sponsor
Syndax Pharmaceuticals
Registration Number
NCT05918913
Locations
🇺🇸

Alabama Center for Childhood Cancer And Blood Disorders, Children's of Alabama, Birmingham, Alabama, United States

🇺🇸

Phoenix Children's Hospital, Phoenix, Arizona, United States

🇺🇸

City of Hope, Duarte, California, United States

and more 32 locations
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News

Charm Therapeutics Raises $80M to Advance AI-Designed Menin Inhibitor for AML Treatment

UK-based Charm Therapeutics secured $80 million in Series B funding to advance its next-generation menin inhibitor for acute myeloid leukemia into Phase I clinical trials starting Q1 2026.

HDAC Inhibitors Market Projected to Surge Through 2034 as Next-Generation Cancer Therapies Advance in Clinical Trials

The HDAC inhibitors market across seven major markets is expected to surge significantly by 2034, driven by innovation in cancer therapies and expanding applications beyond traditional hematologic malignancies.

Syndax Reports Strong Q2 2025 Results with Revuforj Revenue Growth and Pending FDA Approval for NPM1 AML

Syndax Pharmaceuticals reported $28.6 million in Revuforj net revenue for Q2 2025, representing a 43% increase over the first quarter despite approximately one-third of patients pausing treatment for stem cell transplants.

Incyte Reports Strong Q2 2025 Results with Jakafi Growth and New Drug Approvals

Incyte reported strong second quarter 2025 financial results with Jakafi net revenues of $764 million, representing 8% year-over-year growth driven by increased demand across all indications.

Budget Impact Analysis Shows Revumenib Cost-Neutral for Health Plans Despite High Specialty Drug Costs

A recent budget impact analysis demonstrates that revumenib (Revuforj) for relapsed/refractory acute leukemias with KMT2A translocation would be cost-neutral for health plans over three years.

Syndax Pharmaceuticals Appoints Dr. Nicholas Botwood as New R&D Head and Chief Medical Officer

Dr. Nicholas Botwood joins Syndax Pharmaceuticals from Bristol Myers Squibb, bringing 25 years of oncology drug development and commercialization experience to accelerate the company's cancer therapy pipeline.

Kura Oncology's Menin Inhibitor Ziftomenib Shows Promise in Mid-Stage Cancer Trial

Kura Oncology and Kyowa Kirin report positive results from their Phase 2 clinical trial evaluating ziftomenib, a novel menin inhibitor for cancer treatment.

Syndax Highlights FDA-Approved Therapies and Anticipated Milestones at J.P. Morgan Healthcare Conference

Syndax launched Revuforj (revumenib) for relapsed/refractory acute leukemia with KMT2A translocation, receiving NCCN guideline inclusion for AML and ALL.

Syndax's Revuforj Approved for Leukemia, Biosion Inks $940M Antibody Deal with Aclaris

• Syndax Pharmaceuticals' Revuforj (revumenib) received FDA approval as the first menin inhibitor for relapsed or refractory acute leukemia with specific genetic translocations. • Biosion granted Aclaris Therapeutics exclusive global rights to develop two antibodies, including BSI-045B (anti-TSLP) and BSI-502 (bispecific TSLP/IL4R), for up to $940 million. • Novartis expanded its radiopharma portfolio, licensing a somatostatin receptor 2 radiotherapeutic candidate from Ratio Therapeutics for cancer, potentially worth $745 million plus royalties.

Syndax's Revuforj (revumenib) Receives FDA Approval for KM2A-Rearranged Leukemia

Syndax Pharmaceuticals' Revuforj (revumenib) has gained FDA approval for treating adult and pediatric patients with relapsed or refractory KM2A-rearranged acute myeloid leukemia (AML).

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