Serina Therapeutics reported that the U.S. Food and Drug Administration has placed a clinical hold on the investigational new drug application for its lead Parkinson’s disease candidate, SER‑252. The hold was issued after the FDA requested additional information on a commonly used excipient in the formulation.
The request does not involve the active drug or its mechanism of action. Serina said it will provide the requested data promptly and expects to receive a formal clinical‑hold letter within 30 days.
The hold could delay the start of the registrational trial for SER‑252, which the company had planned to begin in the fourth quarter of 2025. Earlier this year, Serina secured up to $20 million in financing, drawing down a $5 million tranche in October, and reported a reduced net loss for Q1 2025 compared with Q1 2024. The company remains on track for global trial initiation in Q4 2025, with first‑patient dosing expected before year‑end, but the hold may push U.S. enrollment to Q1 2026.
Serina’s CEO, Steve Ledger, said the issue is a normal part of the drug‑development process and that the company will work expeditiously to resolve the FDA’s concerns. The company had previously received positive feedback from the FDA on its 505(b)(2) NDA pathway for SER‑252, which leverages existing apomorphine data combined with its proprietary POZ Platform™.
The clinical hold is a regulatory hurdle that could postpone the program’s timeline and impact the company’s development milestones, but it does not affect the active drug’s safety profile or mechanism of action.
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