Cero Therapeutics Holdings Inc. (Nasdaq: CERO) announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation $(ODD)$ to its lead drug candidate, CER-1236, for the treatment of acute myeloid leukemia $(AML.AU)$. This designation highlights the significance of developing innovative treatments for conditions affecting fewer than 200,000 patients in the U.S. annually. CER-1236, currently in Phase 1 clinical trials, utilizes engineered T cell therapeutics that incorporate phagocytic mechanisms. The ODD status provides Cero with several incentives, including FDA assistance in trial design, access to the FDA Orphan Drug Grants Program, exemption from the drug approval application fee, and eligibility for seven years of marketing exclusivity.
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