Serina Therapeutics Surges 30% on FDA Approval for SER-252 Parkinson's Treatment

Serina Therapeutics, Inc. (SER) saw its stock price climb above 30% following major regulatory news that has energized investor confidence in the clinical-stage biotech company. The catalyst: the U.S. Food and Drug Administration cleared the Investigational New Drug (IND) application for SER-252, an investigational apomorphine-based therapy designed to address advanced Parkinson’s disease after a regulatory pause that lasted since November 2025.

Market Breakthrough: FDA Green-Lights Serina’s Advanced Therapy

The IND clearance represents a critical validation for Serina’s approach to treating one of neurology’s most challenging conditions. This regulatory approval enables Serina to move forward with site-level preparation and initiate its Phase 1b registrational clinical study in patients with advanced Parkinson’s disease. According to Grandview Research, the global Parkinson’s disease treatment market reached $5.65 billion in 2024 and is anticipated to expand to $7.58 billion by 2030, representing a compound annual growth rate of 5.04%—a substantial opportunity that underscores the commercial potential of Serina’s program.

The timing of this clearance is particularly significant given the competitive landscape. SER-252 is engineered to deliver continuous dopaminergic stimulation (CDS), a mechanism proven to mitigate levodopa-related motor complications such as dyskinesia. Preclinical research has demonstrated that the therapy can achieve this benefit without triggering skin reactions, a notable advantage in treatment tolerability.

The POZ Platform: Serina’s Foundation for Next-Generation Neurological Treatments

Behind SER-252 lies Serina’s proprietary POZ platform—a synthetic, water-soluble, low-viscosity polymer called poly(2-oxazoline). This technology is designed to enhance both the efficacy and safety of multiple drug modalities, including small molecules, RNA-based therapeutics, and antibody-based drug conjugates. The platform’s versatility has attracted notable partnerships: Serina maintains a non-exclusive license agreement with Pfizer, Inc. to deploy POZ polymer technology in lipid nanoparticle drug delivery formulations, signaling broader validation of the platform’s potential.

Navigating Regulatory Hurdles: The Path to Clinical Trials

The road to FDA clearance was not without obstacles. In early November 2025, Serina received a clinical hold request questioning the safety profile of trehalose, an excipient proposed for subcutaneous administration in SER-252. Rather than derailing the program, Serina responded comprehensively in early December 2025 with a detailed data package addressing FDA concerns. The submission included comparative information from approved products already containing trehalose and additional nonclinical analyses supporting the proposed dosage and administration route.

The FDA’s clearance of the IND application came with approval of a revised protocol that establishes a single ascending dose (SAD) phase for the SER-252-1b trial. Clinical activities are now anticipated to commence in the first quarter of 2026. “FDA clearance of the IND is a major milestone for Serina and underscores the promise of the SER-252 program,” said Steve Ledger, Chief Executive Officer of Serina Therapeutics.

Expanding Pipeline and Market Opportunity for Serina

Beyond SER-252, Serina maintains a robust development pipeline leveraging its POZ platform. SER-270, designated as a POZ-VMAT2 inhibitor, represents a once-weekly injectable option for tardive dyskinesia (TD), another serious neurological condition with limited treatment options. The company is also advancing additional platform applications—POZ-LNP, POZ-ADC, and POZ-AOC—through a combination of internal development and partnership arrangements, positioning Serina to capture value across multiple neurological indications.

The stock closed at $3.60, with year-to-date trading ranging between $1.71 and $7.92, reflecting the inherent volatility of clinical-stage biotechnology. However, with FDA clearance now secured and Phase 1b trials on the horizon, Serina has cleared a significant regulatory milestone that should attract sustained investor interest in its neurological therapy platform.