Serina Therapeutics (SER) stock surged on Tuesday after the biotechnology company received positive feedback from the U.S. Food and Drug Administration (FDA) for SER-252. SER-252 is the company’s investigational apomorphine therapy developed on its POZ platform. It’s designed to provide continuous dopaminergic stimulation (CDS) via a single or twice-weekly subcutaneous injection. CDS can reduce motor fluctuations, making SER-252 a potential treatment for patients with advanced Parkinson’s disease.
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Serina Therapeutics noted that the FDA’s support will allow it to advance SER-252 in a registrational clinical study program through the 505(b)(2) NDA pathway. With this, the company may conduct an initial study as part of a registrational trial program. This is subject to standard clinical and nonclinical requirements, as well as finalization of documentation when an Investigational New Drug (IND) application is submitted.
Steve Ledger, CEO of Serina Therapeutics, said, “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.”
Serina Therapeutics Stock Movement Today
Serina Therapeutics stock was up 22.87% in pre-market trading on Tuesday, following a slight dip yesterday. The shares have rallied 12.57% year-to-date but were down 32.16% over the past 12 months. Today’s news came with heavy trading of SER stock, with some 910,000 shares traded, compared to a three-month daily average of about 30,000 units.
Is Serina Therapeutics Stock a Buy, Sell, or Hold?
Turning to Wall Street, the analysts’ consensus rating for Serina Therapeutics is Moderate Buy, based on one Buy rating over the past three months. With that comes a $15 price target, representing a potential 165.96% upside for the shares.
TipRanks’ AI analyst Spark rates Serina Therapeutics a Neutral (47) with a $5.50 price target. It cites “significant financial challenges” as reasons for this stance.
