Serina Therapeutics Submits Complete Response to FDA Clinical Hold for SER-252
Serina Therapeutics has submitted a complete response to the FDA's clinical hold letter for SER-252, the company's lead program for advanced Parkinson's disease. The FDA had placed the company's IND application for SER-252 on clinical hold pending additional information related to a commonly used formulation excipient. On November 25, the FDA issued a formal full clinical hold letter specifying the information required to permit initiation of the planned Phase 1b registrational study, SER-252-1b. The issues identified by the FDA do not relate to the apomorphine active drug substance, its mechanism of action, the use of the enFuse device or the broader 505(b)(2) NDA development pathway previously discussed with the Agency. Serina's complete response, submitted on December 9, 2025, includes a detailed data package supporting the proposed use of trehalose as a subcutaneous excipient at the intended dose, including comparative information to approved products containing trehalose and additional nonclinical analyses; and a revised protocol to initiate the single ascending dose phase. Initiation of the SAD phase of the SER-252-1b trial is anticipated to begin in Q1 2026. While dosing cannot begin until the clinical hold is lifted, Serina continues site start-up and regulatory activities in Australia and other regions as part of the global registrational program. In Australia, the company now expects first-patient-in in Q1 2026.
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Serina Therapeutics Receives FDA Clearance for IND Application
- FDA IND Clearance: Serina Therapeutics announced that its IND application for SER-252 has been cleared by the FDA, allowing the company to proceed with preparations for a planned Phase 1b registrational study, which is expected to significantly advance treatment options for Parkinson's disease patients.
- Stock Surge: Following the FDA clearance announcement, Serina's shares surged over 70% in pre-market trading, reflecting strong market optimism for the therapy, particularly after experiencing a setback in November 2025 when the FDA placed a clinical hold on its trials.
- Trial Design Support: The FDA had previously provided written feedback supporting Serina's proposed registrational trial design under the 505(b)(2) NDA pathway, indicating a clear path forward for the therapy to address significant unmet medical needs.
- Market Sentiment Shift: Following the announcement, investor sentiment on Stocktwits shifted from 'bearish' to 'extremely bullish', accompanied by a surge in message volume, indicating strong market interest and potential investment opportunities for SER-252.
Meta Platforms Reports Strong Q4 Earnings, Shares Surge
- Strong Financial Results: Meta reported fourth-quarter revenue of $59.89 billion, exceeding analyst expectations of $58.30 billion, indicating robust performance in the recovering advertising market, which is likely to drive further stock price increases.
- Earnings Growth: The company posted adjusted earnings of $8.88 per share, surpassing the forecast of $8.16 per share, reflecting significant improvements in cost control and operational efficiency, thereby boosting investor confidence.
- Stock Price Surge: Following the earnings report, Meta's shares jumped 8.2% in pre-market trading to $723.70, indicating a positive market sentiment towards the company's growth prospects, which may attract more investor interest.
- Optimistic Sales Guidance: Meta's first-quarter sales guidance exceeded market expectations, further solidifying its leadership position in the digital advertising space and suggesting continued benefits from the recovery in advertising spending.
