CERO Therapeutics Holdings, Inc. announced on June 17, 2025, that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for its lead drug candidate, CER-1236. This designation is specifically for the treatment of acute myeloid leukemia (AML).
Orphan Drug Designation underscores the importance of developing new treatments for AML and recognizes the potential for CER-1236 to offer a differentiated approach. CER-1236 is an innovative therapy that engineers a cancer patient's own T cells to deploy phagocytic mechanisms alongside built-in target cell destroying mechanisms.
The ODD status provides CERO Therapeutics with several incentives, including FDA assistance in designing clinical trials, access to the FDA Orphan Drug Grants Program, exemption from the drug approval application fee, and eligibility for seven years of marketing exclusivity if approved. This designation is expected to prove both medically and financially valuable for the company.
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