Syndax Pharmaceuticals
Syndax Pharmaceuticals is a clinical-stage oncology innovator focused on developing first-in-class therapies for acute leukemias and chronic graft-versus-host disease, with key products including revumenib and axatilimab.
Company Overview
Syndax Pharmaceuticals is a clinical-stage oncology company specializing in developing first-in-class therapies for acute leukemias and chronic graft-versus-host disease. The company aims to obtain regulatory approval and commercialize drugs to extend and improve the lives of cancer patients. As of March 31, 2024, Syndax Pharmaceuticals had cash, cash equivalents, and investments totaling $522 million.
Revumenib Development
Revumenib is a small molecule inhibitor targeting the menin-KMT2A interaction, developed by Syndax Pharmaceuticals. It is intended for the treatment of KMT2A-rearranged acute leukemias and NPM1-mutated AML. The drug is in various stages of clinical trials, including Phase 1, Phase 2, pivotal, and registration stages, and has received FDA Priority Review for its New Drug Application in relapsed/refractory KMT2A-rearranged acute leukemia. A pivotal trial will be initiated by the end of 2024, combining revumenib with venetoclax and azacitidine for specific leukemia patients.
Axatilimab Development
Axatilimab, an investigational monoclonal antibody developed by Syndax Pharmaceuticals, targets the colony stimulating factor-1 receptor (CSF-1R). It is under study for chronic graft-versus-host disease (GVHD) and idiopathic pulmonary fibrosis. Currently, axatilimab is in registration and Phase 2 stages for its respective indications. The Biologics License Application (BLA) for axatilimab in chronic GVHD has been granted Priority Review by the FDA. The company's partner Incyte plans to initiate two combination trials with axatilimab in chronic GVHD in 2024.
Entinostat in China
Entinostat, another product developed by Syndax Pharmaceuticals, is currently under regulatory review in China. As with other therapies under the company's pipeline, this drug aims to further Syndax's mission to advance cancer treatments and provide new options for patients in need.
Financial Outlook and R&D Expenses
As of March 31, 2024, Syndax Pharmaceuticals had $522 million in cash, cash equivalents, and investments. The company anticipates research and development expenses to be in the range of $240 to $260 million for the full year of 2024. Syndax believes its financial resources are sufficient to fund its research, clinical development, and commercial operations through at least 2026.