Serina Therapeutics Soars 28.55% on FDA Trial Design Approval

Generated by AI AgentBefore the Bell
Tuesday, Aug 26, 2025 4:20 am ET1min read
Aime RobotAime Summary

- Serina Therapeutics' stock surged 28.55% pre-market after FDA approved its SER-252 trial design for advanced Parkinson's.

- The FDA endorsement enables progression under the 505(b)(2) NDA pathway, accelerating drug development timelines.

- The company plans to file an IND application for SER-252 in Q4 2025 to initiate clinical trials for its novel therapy.

On August 26, 2025,

experienced a significant surge in its stock price, rising by 28.55% in pre-market trading.

Serina Therapeutics recently received positive feedback from the FDA regarding the registrational trial design of its drug candidate SER-252 for advanced Parkinson's disease. This feedback supports the company's plan to advance SER-252 into a registrational clinical program under the 505(b)(2) NDA pathway. The FDA's backing has been a key driver for the stock's recent gains, as retail traders anticipate further advancements in the drug's development.

Serina Therapeutics has also announced plans to file an Investigational New Drug (IND) application for SER-252 in the fourth quarter of 2025. This move is part of the company's strategic efforts to accelerate the development of its novel Parkinson's therapy. The IND filing is a crucial step towards initiating clinical trials and bringing SER-252 closer to market.

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