Serina Therapeutics Inc. has submitted a complete response to the U.S. Food and Drug Administration's (FDA) clinical hold letter for its lead program, SER-252, aimed at treating advanced Parkinson's disease. The submission addresses FDA requests regarding a commonly used formulation excipient, specifically providing data supporting the use of trehalose as a subcutaneous excipient. The company is awaiting FDA feedback, with the first patient in for the registrational Phase 1b study targeted for the first quarter of 2026, pending resolution of the clinical hold and regulatory approvals. No grant or funding from multiple organizations is mentioned.
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