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Investing.com -- Serina Therapeutics (NYSE American:SER) stock soared 28% in after-hours trading Monday following the company’s announcement that it received supportive feedback from the FDA regarding its advanced Parkinson’s disease treatment.
The clinical-stage biotechnology company revealed that the U.S. Food and Drug Administration has provided written feedback supporting the advancement of SER-252 (POZ-apomorphine) in a registrational clinical study program under the 505(b)(2) NDA pathway. This regulatory approach could potentially streamline the approval process by allowing Serina to leverage existing data on apomorphine.
"People living with advanced Parkinson’s need more consistent relief from motor fluctuations and our data to date suggest that SER-252 may reliably improve daily function," said Steve Ledger, Chief Executive Officer of Serina Therapeutics in the company’s announcement.
The company plans to include a pharmacokinetic bridging component to an approved apomorphine product as part of its development strategy. According to Serina, the FDA indicated that the company’s initial study may be designed as part of a registrational trial program, subject to standard requirements and documentation finalization at the time of IND submission.
Serina is developing SER-252 using its proprietary POZ Platform drug optimization technology. The company plans to submit its U.S. IND application in the fourth quarter of 2025 and begin dosing patients in Australia during the same period. U.S. enrollment is expected to begin in the first quarter of 2026 following IND clearance.
The company also noted that this regulatory feedback provides validation for its platform technology, potentially enabling similar 505(b)(2) pathways for other compounds in its pipeline of POZ-enabled small molecules.
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