Serina Therapeutics Shares Face Pressure Following FDA Setback

AgeX Therapeutics US00848H1086

The equity of Serina Therapeutics, the biotechnology firm created from its merger with AgeX Therapeutics, is experiencing a pronounced decline. This downturn comes in direct response to a regulatory obstacle encountered by the company's lead drug candidate.

The recent share price weakness was triggered by an early November decision from the U.S. Food and Drug Administration (FDA). The agency placed a clinical hold on the Investigational New Drug (IND) application for SER-252, a promising treatment for advanced Parkinson's disease. Importantly, the FDA's request centers on obtaining more data regarding a common excipient used in the drug's formulation; the active compound itself and its mechanism of action are not under question.

Company management anticipates formal communication from the regulator within a 30-day window and is actively working to address the agency's inquiries. The primary objective remains to initiate the planned registration study at the earliest possible date.

Financial Performance and Development Pipeline

Shortly before this development, Serina Therapeutics released its financial results for the third quarter of 2025. The company reported a net loss of $4.6 million, or $0.45 per share. While this figure surpassed analyst estimates of a $0.53 per-share loss, it marks a reversal from the net income of $1.4 million recorded in the comparable quarter the previous year.

Beyond SER-252, Serina's pipeline includes SER-270 for Tardive Dyskinesia. Preparations for its IND submission are targeted for completion in 2026. To bolster its balance sheet, the company secured up to $20 million in September through a convertible note and warrants, of which $5 million has already been drawn down.

Share Performance and Critical Path Forward

The stock has come under significant selling pressure, shedding approximately 17% of its value over a single week. Viewed over a one-month horizon, the decline exceeds 25%.

The immediate future for Serina Therapeutics is heavily contingent on a swift resolution with the FDA. Should the management team successfully and promptly alleviate the regulator's concerns, it could potentially catalyze a reversal in the stock's trajectory. The next quarterly earnings report is expected by late March 2026. In the near term, however, the share price movement will be largely dictated by progress in the ongoing dialogue with regulatory authorities.