Serina Therapeutics, a biotechnology company based in Huntsville, Alabama, is making headlines after receiving a significant boost from the U.S. Food and Drug Administration (FDA) for its investigational Parkinson’s disease treatment, SER-252. The company’s announcement on August 25, 2025, sent its stock soaring by 28% in after-hours trading, according to Investing.com, underscoring the market’s enthusiasm for this potential breakthrough in neurological disease treatment.
At the heart of Serina’s approach is its proprietary POZ Platform™, a drug optimization technology built around a synthetic, water-soluble polymer called poly(2-oxazoline). This technology is designed to improve the delivery and pharmacokinetic profiles of existing drugs, especially those with narrow therapeutic windows or problematic side effects. In the case of SER-252, the active agent is apomorphine—an established therapy for advanced Parkinson’s disease—reformulated to provide continuous dopaminergic stimulation (CDS) via a single or twice-weekly subcutaneous injection.
Steve Ledger, Chief Executive Officer of Serina Therapeutics, expressed optimism about the FDA’s response. “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,” Ledger said in the company’s announcement. He added, “Based on the FDA’s written feedback, we plan to advance SER-252 on a registration-directed 505(b)(2) NDA regulatory pathway. Our development plan is designed to be rigorous and capital efficient. We aim to streamline a potential NDA while generating the clinical and pharmacologic evidence to support regulatory review and improve patients’ lives.”
The FDA’s written feedback, received after a recent Type B meeting, supports Serina’s plan to move SER-252 into a registrational clinical study program under the 505(b)(2) New Drug Application (NDA) pathway. This regulatory route is notable because it allows companies to leverage existing data on previously approved drugs—in this case, apomorphine—potentially accelerating the approval process and reducing both time and cost.
Serina’s development strategy includes a pharmacokinetic (PK) bridging component to an already approved apomorphine product, aligning with the requirements of the 505(b)(2) NDA pathway. According to the company, the FDA indicated that Serina’s initial study could be designed and conducted as a component of a registrational trial program, provided it meets standard clinical and nonclinical requirements and that all documentation is finalized at the time of Investigational New Drug (IND) submission.
The company has mapped out a series of regulatory and clinical milestones for the coming months. Serina plans to submit the U.S. IND application in the fourth quarter of 2025, incorporating the FDA’s recommendations. In parallel, the company expects to begin dosing patients in Australia during the same quarter as part of the global registrational program. Data from these patients will contribute to the overall data package for regulatory review and potential approval. If all goes according to plan, U.S. enrollment for the clinical trial is expected to start in the first quarter of 2026, following IND clearance.
The upcoming SER-252-1b study is designed as a randomized, double-blind, placebo-controlled Phase 1b trial. It will feature single-ascending-dose cohorts (five cohorts of eight patients each, totaling 40 participants) and multiple-ascending-dose cohorts (up to three cohorts of sixteen patients each, totaling 48 participants) in adults with Parkinson’s disease and motor fluctuations. The study aims to evaluate the safety, tolerability, and pharmacokinetics of subcutaneous SER-252 versus placebo. Exploratory efficacy measures will include MDS-UPDRS motor scores and structured motor-state assessments—key indicators of how well patients manage movement-related symptoms.
Dose escalation in the trial will be carefully monitored by a Safety Review Committee, and the study will be conducted across sites in both the U.S. and Australia. The use of Enable Injections’ enFuse™ wearable drug delivery platform is another notable feature, offering patients an easy-to-administer, long-acting subcutaneous injection that could reduce the treatment burden often associated with advanced Parkinson’s disease therapies.
Serina’s POZ Platform™ is central to the company’s ambitions beyond SER-252. The technology is engineered to provide greater control in drug loading and more precise rates of release for attached drugs delivered via subcutaneous injection. According to Serina, this approach could help drugs with a narrow therapeutic index maintain more stable and desirable levels in the blood, potentially improving both safety and efficacy. The company believes its POZ technology could be applied across a broad range of therapeutic agents, including small molecules, RNA-based therapeutics, and antibody-drug conjugates (ADCs).
“Beyond SER-252, we are advancing a pipeline of POZ-enabled small molecules that may follow similar 505(b)(2) NDA pathways where appropriate,” Ledger said. “The FDA’s feedback provides early proof-of-principle for our platform, confirming that we can effectively align with the agency's expectations for the 505(b)(2) NDA regulatory pathway. Each program will follow its own science and require FDA dialogue, but our goal remains to unlock new possibilities in treatment and deliver better options to patients as quickly as possible.”
Industry analysts have taken note of Serina’s progress, particularly in light of the company’s stock surge following the FDA announcement. The positive regulatory feedback not only validates Serina’s proprietary technology but also signals potential for similar accelerated pathways for other compounds in its pipeline. This could position Serina as a key player in the race to develop more effective and patient-friendly therapies for neurological and other chronic diseases.
Of course, as with any clinical-stage biotechnology company, there are inherent risks and uncertainties. Serina’s public statements have included the usual cautionary notes about the unpredictability of research and development, the challenges of meeting clinical endpoints, and the possibility of unfavorable new data or regulatory interpretations. The company has emphasized that all forward-looking statements are subject to change and that actual results may differ materially from current expectations.
Still, for patients, families, and clinicians grappling with the daily realities of advanced Parkinson’s disease, the prospect of a more consistent and convenient therapy is cause for hope. Serina’s upcoming trials will be closely watched, and the company’s ability to deliver on its promise could have ripple effects far beyond its own balance sheet.
As the clinical program for SER-252 moves forward, the eyes of the biotechnology world—and the Parkinson’s community—will remain fixed on Huntsville, Alabama, and the team at Serina Therapeutics.