Serina Therapeutics Receives FDA Approval to Advance Parkinson's Disease Treatment
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1d ago
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Source: Newsfilter
- FDA Approval Milestone: Serina Therapeutics has received FDA clearance for its IND application for SER-252, marking a significant advancement in the treatment of Parkinson's disease and expected to facilitate subsequent clinical trials to meet the urgent market demand for new therapies.
- Clinical Trial Initiation: This approval enables Serina to commence Phase 1b clinical trials in Australia, evaluating the efficacy of SER-252 in patients with advanced Parkinson's disease, which is anticipated to provide new treatment options and drive future company growth.
- Platform Technology Advantage: Serina's POZ platform technology aims to enhance drug efficacy and safety by improving drug release control, which is expected to reduce side effects during treatment with SER-252, thereby improving patients' quality of life.
- Strategic Partnership Potential: Serina plans to expand the applications of its POZ platform through collaborations with companies like Pfizer, enhancing its market competitiveness in the biotechnology sector and driving long-term company growth.
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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.
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Moderate Buy
Current: 2.720
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11.00
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11.00
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11.00
Current: 2.720
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11.00
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11.00
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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.
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.
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