Serina Therapeutics CEO Video Unveils FDA Alignment Advancing Parkinson’s Therapy -( $SER $IBB $XBI )

By John F. Heerdink, Jr.

Serina Therapeutics (NYSE American: SER) CEO Steven A. Ledger shared encouraging insights in a recent video presentation about the company’s accelerated FDA regulatory pathway for its lead asset, SER-252, targeting advanced Parkinson’s disease. The video can be viewed here:
Serina CEO FDA Alignment Video.

In the video, Ledger explains how Serina’s proprietary drug reformulation approach leverages well-established small molecule therapies, specifically reformulating apomorphine into a patient-friendly, long-acting injectable using their proprietary POZ Platform™ technology. This strategy substantially lowers clinical risk and shortens development timelines compared to traditional new drug development. The FDA has provided transformative feedback, supporting a fast-tracked 505(b)(2) regulatory pathway—a streamlined approval process that utilizes existing clinical data on apomorphine combined with Serina’s novel formulation.

Highlights

Ledger highlights that SER-252 aims to solve key limitations of current apomorphine treatments, which are often invasive and inconvenient, by offering a long-acting injectable profile that improves patient convenience, adherence, and overall quality of life. This regulatory nod positions SER-252’s upcoming phase 1b registrational trial for initiation in Q4 2025 in Australia, with U.S. enrollment expected in early 2026. The trial is designed to be rigorous yet capital efficient, with the IND already submitted and ethical approvals in place overseas.

Beyond

Beyond SER-252, Serina intends to replicate this development model across multiple pipeline assets using the 505(b)(2) pathway, leveraging the platform’s validation as early proof of principle. This approach enables the company to bring a portfolio of reformulated small molecules, potentially close to late-stage assets, to market more efficiently, addressing unmet patient needs across neurological and other therapeutic areas. Ledger expresses optimism about building Serina into a multi-asset company impacting thousands of patients worldwide over the next decades.

Innovative Business Model

The video also offers a detailed explanation of how this FDA alignment reflects a milestone not only for SER-252 but also for Serina Therapeutics’ innovative business model centered on risk-reduced drug reformulations, underscoring its potential to accelerate drug development and create meaningful patient benefits.

Enthusiasm

This announcement, together with the clinical and regulatory advances, has driven enthusiasm, reflecting confidence in Serina’s strategic pathway and the promise of its POZ Platform™ in the competitive Parkinson’s disease treatment landscape.

Regulatory Progress

This regulatory progress is supported by recent FDA feedback endorsing the registrational design and the company’s plan to leverage the established safety profile of apomorphine with its proprietary technology to enhance efficacy and patient experience. The data consolidated from all ongoing trials will underpin regulatory filings aiming to bring these therapies to market efficiently and responsibly—offering hope for better options to those living with Parkinson’s disease.

The Sum…

Serina Therapeutics’ (NYSE American: SER) innovative approach and clear regulatory path mark a significant milestone in its mission to revolutionize drug optimization and deliver impactful treatments in neurology and beyond.