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CERo Therapeutics Says FDA Grants Fast Track Designation to Potential Leukemia Treatment
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CERo Therapeutics Says FDA Grants Fast Track Designation to Potential Leukemia Treatment
Sep 5, 2025 6:13 AM

08:46 AM EDT, 09/05/2025 (MT Newswires) -- CERo Therapeutics ( CERO ) said Friday that the US Food and Drug Administration has granted fast track designation to its CER-1236 investigational compound as potential treatment for acute myeloid leukemia.

The designation, which is on top of the existing orphan drug designation for the compound, gives CERo potential eligibility for priority review by the FDA and allows submission of data on a rolling basis, the company said.

The company said it is currently conducting a phase 1/1b study to evaluate the safety and preliminary efficacy of CER-1236 in patients with acute myeloid leukemia that is either relapsed, refractory, or in remission.

Shares of the company were falling more than 9% in recent premarket activity Friday.

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