Parkinson’s Drug Milestone: Serina Therapeutics Wins FDA Support, HCW Wainwright Reaffirms Buy Rating on SER Stock ( $SER $IBB $XBI )

By John F. Heerdink, Jr.

HCW Wainwright has reiterated its
Buy rating
on Serina Therapeutics (NYSE American: SER), emphasizing both the company’s clinical progress and robust valuation metrics as key drivers for investor optimism.

Company Snapshot and Market Performance

Serina Therapeutics (SER) currently trades at
$5.04 per share
with a market capitalization of
$51.62 million. HCW Wainwright’s analysts, Raghuram Selvaraju, Ph.D., and Daniel Smith, recently reaffirmed their
Buy rating
and
12-month price target of $15.00
for the stock, reflecting significant upside potential as the company advances its clinical pipeline based upon their novel & proprietary POZ platform technology that has been designed for programmable, targeted delivery of a broad range of small molecules. The technology has been clinically demonstrated to safely enable continuous drug delivery via a once weekly subcutaneous injection. The POZ platform is customizable, versatile and can be dosed via IV, SC or IM routes to address a broad range of clinical indications.

Regulatory Milestone: SER-252 Gets FDA Green Light

This week, Serina reported receiving written feedback from the FDA supporting advancement of its key asset,
SER-252 (POZ-apomorphine), in a registrational clinical study for advanced Parkinson’s disease under the accelerated 505(b)(2) NDA pathway. The FDA’s feedback, based on a Type B meeting, enables Serina to leverage its proprietary
POZ technology
for controlled release, aiming to provide patients with more consistent relief from motor fluctuations while minimizing injection site reactions. Clinical development is set to initiate pharmacokinetic bridging to an approved apomorphine product. The anticipated U.S. IND filing in Q4 2025 is poised to kick off patient dosing in Australia by year-end and U.S. enrollment in early 2026. Initial clinical data could be available in the second half of 2026—a potential inflection point for the stock.

Strong Commercial Potential and Market Metrics

Parkinson’s disease (PD) afflicts over 1 million people in the U.S., with about 150,000 suffering from advanced PD who may benefit from SER-252. Comparable currently approved therapies are priced at up to $119,000 per year, positioning Serina’s conservative pricing assumptions of $50,000 (U.S.) and $35,000 (Europe) as highly competitive yet capable of yielding forecasted peak annual sales exceeding $1.1 billion across major markets by 2040.

International Approval Footprint for enFuse Delivery

The
enFuse® delivery device
for SER-252 has just received market authorization from Brazil’s ANVISA, and earlier in 2025, secured registration with the UK regulator (MHRA) and CE Mark for the EU. This regulatory momentum bodes well for SER-252’s global adoption prospects.

Pipeline Expansion and Long-Term Upside

Serina’s second clinical candidate,
SER-270 (POZ-VMAT2i), advances in the lucrative tardive dyskinesia market, with additional applications in Huntington’s chorea under evaluation. Current forecasts do not assign value to SER-270, leaving significant room for pipeline-driven upside as development progresses.

Financial Health and Valuation

As of mid-2025, Serina reported roughly $6 million in cash following a stock sale. HCW’s DCF valuation approach models a 12% discount rate, 2% terminal growth, and a conservative 40% probability of approval for SER-252, resulting in an enterprise value of $300 million and the $15 price target.

Risks and Analyst Caution

Potential risks include delays in clinical progression, regulatory setbacks, slower-than-expected commercial uptake, competitive dynamics, partnership uncertainties, and possible near-term dilution.

SOURCES