CERO Therapeutics Holdings, Inc. announced on March 27, 2025, that it has received a positive review from the U.S. Food and Drug Administration (FDA) on an amendment to its Investigational New Drug (IND) application concerning Chemistry, Manufacturing and Controls (CMC). This positive review marks the completion of the company’s final commitment to the FDA prior to initiating patient dosing.
The FDA's positive review also shortens the manufacturing timeline for CER-1236 by approximately one week. With this critical step completed, CERO Therapeutics is on track to meet its anticipated timeline of dosing initial subjects in its Phase 1 clinical trial during the first half of 2025.
CEO Chris Ehrlich highlighted the significance of this achievement, noting that it avoids additional delays often encountered before trial initiation. The company also reported the acceptance of an abstract for presentation at the 2025 American Society of Clinical Oncology (ASCO) conference, further showcasing its scientific progress.
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