Serina Therapeutics receives FDA approval for Parkinson's trial, shares rise after hours.

Serina Therapeutics has received FDA approval for a clinical trial of SER-252, a treatment for advanced Parkinson's disease. The trial aims to evaluate the safety and efficacy of SER-252, which is an investigational apomorphine therapy designed to provide continuous dopaminergic stimulation. Shares of the company rose after hours following the announcement.

Serina Therapeutics (NYSE American: SER) has received positive feedback from the U.S. Food and Drug Administration (FDA) supporting the advancement of SER-252, a POZ-enabled apomorphine treatment for advanced Parkinson's disease, through a 505(b)(2) New Drug Application (NDA) pathway [1]. The company plans to initiate a registrational clinical study program with a comprehensive development strategy.

Key upcoming milestones include a U.S. Investigational New Drug (IND) submission in the fourth quarter of 2025, patient dosing in Australia also in the fourth quarter of 2025, and U.S. enrollment beginning in the first quarter of 2026 [1]. The registrational study, SER-252-1b, is designed as a randomized, double-blind, placebo-controlled Phase 1b trial, evaluating safety, tolerability, and pharmacokinetics in Parkinson's disease patients with motor fluctuations.

The FDA's supportive feedback on the 505(b)(2) strategy establishes a potential precedent for Serina's broader pipeline, as explicitly noted by management. This regulatory validation may accelerate future programs utilizing the same platform technology. The planned trial follows a rigorous design: randomized, double-blind, and placebo-controlled with both single-ascending-dose (n=40) and multiple-ascending-dose (n=48) components [1].

Shares of Serina Therapeutics rose after hours following the announcement of the FDA's supportive feedback, reflecting investor optimism about the company's progress in developing innovative treatments for neurological diseases.

References:
[1] https://www.stocktitan.net/news/SER/serina-therapeutics-announces-fda-feedback-supports-registrational-8glwmyn2n9i4.html