Serina Therapeutics filed a complete response to the U.S. Food and Drug Administration’s clinical hold on its lead Parkinson’s disease candidate, SER‑252, on December 9, 2025. The hold, issued on November 25, 2025, was triggered by the FDA’s request for additional information on the excipient trehalose used in the formulation.
The company’s response addresses the agency’s concerns by providing detailed analytical data, stability studies, and a revised manufacturing plan that demonstrates trehalose can be produced under Good Manufacturing Practice conditions without compromising product safety or efficacy. By meeting the FDA’s requirements, Serina aims to have the hold lifted so that the planned Phase 1b registrational study can proceed.
The Phase 1b trial is scheduled to begin in the first quarter of 2026. If the FDA accepts the response, the company will be able to enroll patients and collect the data needed to support a future New Drug Application. A delay in lifting the hold would postpone the trial and could extend the development timeline by several months, affecting the company’s projected milestones and funding needs.
Serina’s regulatory progress comes amid significant financial headwinds. Recent filings highlight liquidity pressure and a going‑concern risk, and the company’s cash position is under strain as it continues to invest heavily in clinical development. The regulatory milestone is therefore a positive development, but investors must weigh it against the company’s limited cash runway and the potential need for additional capital to sustain operations through the next phase of development.
CEO Steve Ledger said, “Our priority has been to respond thoroughly and constructively to the FDA’s requests. We believe our submission directly addresses the agency’s questions on trehalose, and we appreciate the FDA’s continued engagement as we work toward initiating the registrational SER‑252‑1b trial.” The statement underscores the company’s commitment to regulatory compliance while acknowledging the ongoing financial challenges.
Overall, the submission represents a critical step toward unlocking SER‑252’s development path, but the company’s financial vulnerabilities remain a key risk factor. Successful lifting of the hold would enable the Phase 1b study and potentially accelerate the drug’s path to market, while a delay could exacerbate liquidity concerns and delay future funding rounds.
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