CERo Therapeutics receives FDA Fast Track Designation for CER-1236 in Acute Myeloid Leukemia

CERO THERAPEUTICS HOLDINGS, INC.

FDA granted Fast Track Designation for CER-1236 in AML, adding to existing Orphan Drug Designation.
Benefits include increased FDA interactions, potential priority review, rolling submission, and expanded access.
Phase 1/1b study underway evaluating CER-1236 in relapsed/refractory AML, MRD-positive, or TP53-mutated MDS/AML.
CEO Chris Ehrlich noted the designation validates program urgency and may accelerate development and market timeline.

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