Syndax's SNDX-5613 Gets FDA Fast Track Designation To Treat Relapsed/Refractory Acute Leukemias

Syndax Pharmaceuticals, Inc. (SNDX), a clinical stage biopharmaceutical company focused on cancer therapies, announced Monday that the U.S. Food and Drug Administration has granted Fast Track Designation or FTD to SNDX-5613 to treat relapsed/refractory acute leukemias.

In pre-market activity on Nasdaq, Syndax shares were gaining around 9 percent to trade at $19.99.

The FTD is given for the treatment of adult and pediatric patients with relapsed or refractory acute leukemias harboring a mixed lineage leukemia rearranged or MLLr or nucleophosmin or NPM1 mutation. SNDX-5613 is the company's highly selective, oral menin inhibitor.

The FDA grants FTD 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. These clinical programs may also be eligible to apply for Accelerated Approval and Priority Review if relevant criteria are met.

Briggs Morrison, Chief Executive Officer of Syndax, said, "Genetically-defined acute leukemias represent an underserved area marked by particularly poor prognosis and limited therapeutic options. 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."

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