CERO Therapeutics Holdings, Inc. announced on September 5, 2025, that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its lead investigational compound, CER-1236, for Acute Myeloid Leukemia (AML). This designation is in addition to the existing Orphan Drug Designation for CER-1236.
FDA’s Fast Track Designation is designed to accelerate the development and review of therapies for serious or life-threatening conditions with unmet medical needs. This status provides CERO Therapeutics with opportunities for increased FDA interactions, potential eligibility for priority review, and the ability to submit data on a rolling basis.
CEO Chris Ehrlich stated that these FDA designations provide important validation regarding the urgency of the condition and the potential the agency sees in the submitted data. He emphasized that these designations are expected to decrease the potential time to market and offer additional medically and financially valuable benefits across the FDA process.
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