Serina Therapeutics Submits Complete Response to FDA Clinical Hold for SER-252
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 10 2025
0mins
Should l Buy SER?
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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Analyst Views on SER
Wall Street analysts forecast SER stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for SER is 11.00 USD with a low forecast of 11.00 USD and a high forecast of 11.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
1 Analyst Rating
1 Buy
0 Hold
0 Sell
Moderate Buy
Current: 2.470
Low
11.00
Averages
11.00
High
11.00
Current: 2.470
Low
11.00
Averages
11.00
High
11.00
About SER
Serina Therapeutics Inc. is a clinical-stage biotechnology company developing a pipeline of wholly owned drug product candidates to treat neurological diseases and other indications. The Company's POZ Platform provides the potential to improve the integrated efficacy and safety profile of multiple modalities including small molecules, RNA-based therapeutics and antibody-based drug conjugates (ADCs). Its proprietary POZ technology is based on a synthetic, water soluble, low viscosity polymer called poly(2-oxazoline). Its POZ technology is engineered to provide greater control in drug loading and more precision in the rate of release of attached drugs delivered via subcutaneous injection. SER-252 is the Company’s lead candidate for advanced Parkinson’s disease. SER-252 is an investigational apomorphine therapy developed with its POZ platform and designed to provide continuous dopaminergic stimulation.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- CEO Presentation Event: Steven Ledger, CEO of Serina Therapeutics, will present at Tribe Public's webinar on February 4, 2026, discussing FDA initiatives that may impact drug development timelines and review processes, potentially altering investor expectations.
- Technology Platform Overview: Serina's POZ Platform™ aims to optimize the efficacy and safety of drug candidates across various modalities, including small molecules, RNA therapeutics, and antibody-drug conjugates, showcasing its potential in treating neurological diseases.
- Industry Impact Analysis: The event will provide attendees with the opportunity to directly question management, reflecting investor concerns regarding FDA policy changes that could influence investment decisions in the biotechnology sector.
- Company Background Information: Serina Therapeutics is a clinical-stage biotechnology company headquartered in Huntsville, Alabama, focused on developing drug candidates for neurological diseases, demonstrating its innovative capabilities in the life sciences field.
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- 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.
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- 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.
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Navigating the New FDA Era: 2026 Strategic Priorities
- CEO Presentation Event: Steven Ledger, CEO of Serina Therapeutics, will present at Tribe Public's webinar on February 4, 2026, discussing FDA initiatives that may impact drug development timelines and review processes, potentially altering investor expectations.
- Technology Platform Overview: Serina's POZ Platform™ aims to optimize the efficacy and safety of drug candidates across various modalities, including small molecules, RNA therapeutics, and antibody-drug conjugates, showcasing its potential in treating neurological diseases.
- Industry Impact Analysis: The event will provide attendees with the opportunity to directly question management, reflecting investor concerns regarding FDA policy changes that could influence investment decisions in the biotechnology sector.
- Company Background Information: Serina Therapeutics is a clinical-stage biotechnology company headquartered in Huntsville, Alabama, focused on developing drug candidates for neurological diseases, demonstrating its innovative capabilities in the life sciences field.
See More
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- Disappointing Delivery Numbers: Xpeng Inc reported delivering 20,011 vehicles in January 2026, a figure that, while substantial, fell short of market expectations, leading to a decline in investor confidence.
- Stock Price Reaction: Following the disappointing delivery results, Xpeng's stock dropped 5.6% in pre-market trading to $16.97, reflecting concerns about the company's future performance among investors.
- Overall Market Trend: U.S. stock futures were lower, with Dow futures falling around 100 points, indicating a cautious market sentiment that could further impact investor attitudes towards Xpeng.
- Industry Impact: The delivery figures from Xpeng may negatively affect overall confidence in the electric vehicle market, especially in an increasingly competitive landscape, prompting investors to reassess their strategies.
See More
DarkIris Inc Reports 27.3% Revenue Growth, Shares Surge
- Significant Revenue Growth: DarkIris Inc reported a year-over-year revenue increase of 27.3% for FY25, reaching $10.08 million compared to $7.92 million in FY24, indicating strong market performance and growth potential.
- Stock Price Surge: Following the positive earnings report, DarkIris shares jumped 104.2% in pre-market trading to $0.68, reflecting investor optimism about the company's future prospects.
- Positive Market Reaction: The release of this earnings report has significantly increased market attention on DarkIris, enhancing investor confidence in its continued growth and potentially attracting more capital inflow.
- Optimistic Industry Outlook: The robust performance of DarkIris not only strengthens its market position but may also provide more opportunities for future financing and expansion plans, further solidifying its competitive edge in the industry.
See More
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.
See More
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.
See More
Wall Street Focuses on Earnings and Commodity Prices
- Earnings Impact: Meta's strong sales forecast and $100 billion AI investment plan drove its stock up in after-hours trading, while Microsoft fell due to slowing cloud growth and soft margin guidance, indicating a divergence in market sentiment towards tech stocks.
- Commodity Market Fluctuations: Gold prices nearing $5600 and silver surpassing $120 reflect investors' demand for safe-haven assets amid economic uncertainty, simultaneously boosting trading volumes in related ETFs like GLD and SLV.
- Market Sentiment: Despite Nasdaq and S&P 500 futures rising by 0.4% and 0.3% respectively, retail sentiment towards SPY and QQQ remains extremely bearish, suggesting ongoing investor concerns about market outlook.
- Upcoming Earnings Reports: Investors are keenly awaiting Apple's earnings report, particularly for insights on iPhone demand and AI roadmap updates, while Western Digital and SanDisk are also set to report today, potentially impacting the data storage sector.
See More
