Serina Therapeutics Provides Regulatory Update on SER-252 Program
Serina Therapeutics, Inc. (SER)
Company Research
Source: GlobeNewswire
- FDA requests additional information on a formulation component - HUNTSVILLE, AL, Nov. 03, 2025 (GLOBE NEWSWIRE) -- Serina Therapeutics, Inc. (“Serina”) (NYSE American: SER), a clinical-stage biotechnology company developing its proprietary POZ Platform™ drug optimization technology, today announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on the Company’s Investigational New Drug (IND) application for SER-252, Serina’s lead development program for advanced Parkinson’s disease. The FDA has requested additional information related to a commonly used excipient in the formulation. The feedback does not relate to the active drug substance or its proposed mechanism of action. Serina intends to work expeditiously with the FDA to address the requests. Serina expects to receive the FDA’s formal clinical-hold letter within 30 days and will provide an update once it has aligned with the FDA on next steps and timelines. In prior interactions, the FDA indic
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SER
News
- Serina Therapeutics Reports Third Quarter 2025 Financial Results and Provides Business HighlightsGlobeNewswire
- Serina Therapeutics Launches Enhanced Corporate Communications Platform to Strengthen Engagement with Patients, Clinicians, and InvestorsGlobeNewswire
- Serina Therapeutics Draws First $5 Million Funding Tranche to Support Registrational Trial of SER-252 in Parkinson's Disease [Yahoo! Finance]Yahoo! Finance
- Serina Therapeutics Draws First $5 Million Funding Tranche to Support Registrational Trial of SER-252 in Parkinson’s DiseaseGlobeNewswire
- Serina Therapeutics Secures Up to $20 Million to Advance Registrational Trial of SER-252 in Parkinson's Disease [Yahoo! Finance]Yahoo! Finance
SER
Sec Filings
- 12/4/25 - Form 4
- 11/26/25 - Form 4
- 11/25/25 - Form 4
- SER's page on the SEC website