CERO Therapeutics Holdings, Inc. provided a corporate update on October 21, 2024, announcing the submission of its Complete Response Letter to the U.S. Food and Drug Administration (FDA). This submission addresses the clinical hold previously placed on the Investigational New Drug (IND) application for CER-1236.
The company has been diligently working to complete experimental studies necessary to resolve the FDA's questions regarding the clinical hold. CERO Therapeutics recently completed communications with the FDA to gain feedback on its approach.
Due to the time required for FDA review, CERO Therapeutics has adjusted its previous guidance for potential entry into the clinic from 2024 to early 2025. The company also reported a cash balance of $3.2 million as of September 30, 2024, which it expects to provide sufficient runway to execute its strategy.
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