Cero Therapeutics Holdings, Inc. (NASDAQ:CERO), a biopharmaceutical company, reported today that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on its Investigational New Drug Application (IND) for CER-1236. The FDA's decision was based on a lack of sufficient pharmacology and toxicology data.
The regulatory body informed Cero Therapeutics of its decision on July 26, 2024, and will provide a detailed official hold letter within 30 days. The FDA has requested the company to wait for this official communication before responding.
Despite the setback, Cero Therapeutics remains optimistic about addressing the FDA's concerns and proceeding with its clinical plans. The company intends to initiate experimental activities immediately, based on previous discussions with the FDA and the recent communication, to resolve the issues cited.
Cero Therapeutics continues to anticipate the commencement of the planned clinical trial for CER-1236 by the end of 2024. This confidence is held despite the current clinical hold and the pending detailed letter from the FDA.
In other recent news, Cero Therapeutics has been making significant strides in the field of biotechnology. The company has been grappling with Nasdaq delisting over share price and value, but remains committed to resolving these deficiencies and maintaining its listing. Cero Therapeutics has until January 15, 2025, to regain compliance.
On the research front, Cero Therapeutics has completed pre-IND manufacturing activities for its lead therapeutic candidate, CER-1236, a crucial step towards meeting regulatory standards for clinical trials. This progress in its engineered T-cell therapeutics designed to combat cancer marks a key milestone for the company.
In addition, Cero Therapeutics has successfully transitioned from a private entity to a public one via a merger with SPAC Phoenix Biotech Acquisition Corporation. The company is now focusing on pre-clinical studies and preparing documentation for clinical trials, with plans to commence clinical trials for CER-1236, targeting hematological malignancies, in 2024. These are among the recent developments in Cero Therapeutics' pursuit of advancing its immunotherapy offerings.
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