Serina Therapeutics Submits Complete Response to FDA Clinical Hold Letter for SER-252 Program
Serina Therapeutics, Inc. (SER)
Company Research
Source: GlobeNewswire
– Company addresses FDA requests regarding formulation excipient – Global site start-up activities continue, with first-patient-in for registrational Phase 1b study targeted for Q1 2026, subject to FDA feedback HUNTSVILLE, Dec. 10, 2025 (GLOBE NEWSWIRE) -- Serina Therapeutics, Inc. (“Serina” or the "Company") (NYSE American: SER), a clinical-stage biotechnology company advancing its lead Investigational New Drug ("IND") candidate, SER-252, for advanced Parkinson's disease, enabled by its proprietary POZ PlatformTM drug optimization technology, today announced that it has submitted a complete response to the U.S. Food and Drug Administration’s (“FDA”) clinical hold letter for SER-252, the Company’s lead program for advanced Parkinson’s disease. As previously disclosed, the FDA placed the Company’s Investigational New Drug (“IND”) application for SER-252 on clinical hold pending additional information related to a commonly used formulation excipient. On November 25, 2025, the FDA is
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News
- Serina Therapeutics Strengthens Leadership Team with Appointment of Dr. Joshua Thomas as VP, Head of Chemistry [Yahoo! Finance]Yahoo! Finance
- Serina Therapeutics Strengthens Leadership Team with Appointment of Dr. Joshua Thomas as VP, Head of ChemistryGlobeNewswire
- Serina Therapeutics Reports Third Quarter 2025 Financial Results and Provides Business HighlightsGlobeNewswire
- Serina Therapeutics Provides Regulatory Update on SER-252 ProgramGlobeNewswire
- Serina Therapeutics Launches Enhanced Corporate Communications Platform to Strengthen Engagement with Patients, Clinicians, and InvestorsGlobeNewswire
SER
Sec Filings
- 12/17/25 - Form 4
- 12/16/25 - Form 4
- 12/12/25 - Form 4
- SER's page on the SEC website