10:42 AM EDT, 06/17/2025 (MT Newswires) -- CERo Therapeutics ( CERO ) said Tuesday that the US Food and Drug Administration has granted orphan drug designation for the company's lead drug candidate CER-1236 as a potential treatment for acute myeloid leukemia, or AML.

The company said CER-1236 is currently under phase 1 clinical trials, with a phase 1/1b study evaluating its safety and preliminary efficacy in patients with AML that is relapsed or refractory, or in remission with measurable residual disease, or newly diagnosed with TP53 mutated AML or MDS/AML.

The orphan drug designation is given to medicinal products intended to treat life-threatening or chronically debilitating diseases and qualifies CER-1236 for certain incentives such as access to FDA grants, according to the company.

Shares of CERo Therapeutics ( CERO ) were up more than 159% in recent trading Tuesday.

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