SNDX-5613 Granted FDA Fast Track Designation for the Treatment of Relapsed/Refractory Acute Leukemias

Syndax Pharmaceuticals, Inc. (“Syndax,” the “Company” or “we”) (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to SNDX-5613 for the treatment of adult and pediatric patients with relapsed or refractory acute leukemias harboring a mixed lineage leukemia rearranged (MLLr) or nucleophosmin (NPM1) mutation. SNDX-5613 is the Company’s highly selective, oral menin inhibitor.

“Genetically-defined acute leukemias represent an underserved area marked by particularly poor prognosis and limited therapeutic options,” said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. “As we move toward initiating our pivotal study, receipt of FTD from the FDA underscores SNDX-5613’s potential to meaningfully improve outcomes for patients with MLLr and NPM1 mutant acute leukemias.”

About Fast Track Designation

Fast Track Designation is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fulfill an unmet medical need, enabling drugs to reach patients earlier. The FDA created this process to help deliver important new drugs to patients earlier and it covers a broad range of serious illnesses. These clinical programs may also be eligible to apply for Accelerated Approval and Priority Review if relevant criteria are met.

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