Serina Secures FDA IND Clearance For SER-252, Marking Major Milestone In Parkinson's Disease Program

Serina Therapeutics has achieved a significant regulatory breakthrough after the U.S. Food and Drug Administration cleared the Investigational New Drug (IND) application for SER-252, its investigational apomorphine therapy for advanced Parkinson’s disease. The announcement triggered a robust market response, with the company’s stock surging over 30% in after-hours trading. This clearance comes after Serina successfully addressed FDA concerns regarding the formulation and advanced its comprehensive development strategy for the promising therapeutic candidate.

FDA Clearance Removes Obstacles For Serina’s Clinical Development

The regulatory milestone represents a key turning point for Serina after navigating a clinical hold that was initially issued in November 2025. The FDA had raised questions about trehalose, a proposed subcutaneous excipient in the SER-252 formulation. Rather than reformulate entirely, Serina submitted a detailed and scientifically rigorous response in December 2025, providing comparative data from approved products already using trehalose and conducting additional nonclinical analyses to demonstrate safety at the intended dose levels.

This targeted approach proved effective. The company’s complete response satisfied regulatory requirements, enabling Serina to move forward with site preparation and regulatory activities necessary for launching the Phase 1b trial. The single ascending dose (SAD) phase of the SER-252-1b study is now anticipated to begin in early 2026, keeping the program on an accelerated timeline despite the temporary setback.

How SER-252’s POZ Platform Technology Differentiates The Therapy

At the core of Serina’s innovation lies the POZ platform—a proprietary technology based on a synthetic, water-soluble, low-viscosity polymer called poly(2-oxazoline). SER-252 leverages this platform to deliver continuous dopaminergic stimulation (CDS), a mechanism specifically engineered to reduce the severity of levodopa-related motor complications, commonly known as dyskinesia, in Parkinson’s disease patients.

Preclinical research supports a key safety advantage: SER-252 is designed to provide the therapeutic benefits of CDS without causing skin reactions—a common adverse effect associated with some existing therapies. This combination of efficacy and tolerability could position Serina’s candidate as a meaningful clinical advancement for patients managing advanced Parkinson’s disease symptoms.

The POZ platform extends beyond SER-252. Serina is developing a diversified pipeline including SER-270, a POZ-VMAT2i therapy for tardive dyskinesia designed as a once-weekly injectable, as well as multiple platform science initiatives designated POZ-LNP, POZ-ADC, and POZ-AOC. Additionally, Serina has licensed its POZ polymer technology to Pfizer for use in lipid nanoparticle drug delivery formulations, demonstrating the broad applicability and recognized value of the platform technology across multiple development partners.

Market Opportunity Expands As Serina Advances Its Program

The regulatory clearance arrives amid a growing market opportunity in Parkinson’s disease therapeutics. According to research from Grandview Research, the global Parkinson’s disease treatment market was valued at approximately $5.65 billion in 2024 and is projected to expand to $7.58 billion by 2030, representing a compound annual growth rate (CAGR) of 5.04% over the 2025-2030 period.

This expanding market reflects both the rising prevalence of Parkinson’s disease globally and the increasing demand for advanced treatment options that can address complications in patients with disease progression. Serina’s entry into this space with a differentiated mechanism of action comes at an opportune moment when physicians and patients are seeking novel therapeutic approaches.

Serina’s Strategic Path Forward In 2026 And Beyond

With the FDA IND clearance secured, Serina is positioned to execute several key milestones throughout 2026. The initiation of the Phase 1b SAD trial in early 2026 represents the first critical step in generating human safety and efficacy data for SER-252. Successful Phase 1b results could accelerate the program toward later-stage development and expand the clinical evidence base.

Beyond SER-252, Serina continues to develop its broader therapeutic pipeline and explore partnerships and out-licensing opportunities for the POZ platform. The Pfizer collaboration serves as a proof point for the platform’s value in the broader biopharmaceutical market. As Serina advances its clinical programs and the Parkinson’s disease treatment market continues to expand, the company is well-positioned to establish itself as an innovator in neurology therapeutics.

The stock closed at $3.60 on the prior trading session, down 0.73%, though the recent regulatory catalyst has shifted momentum significantly. Year-to-date trading has ranged between $1.71 and $7.92, reflecting the volatility typical of clinical-stage biotechnology companies advancing through regulatory milestones.