Serina Therapeutics Stock Slumps Pre-Market After FDA Places Hold On Application To Initiate Clinical Trials For Experimental Therapy

• The agency has requested more information regarding an excipient in the formulation of SER-252, the company said. 
• The company said that it intends to work with the FDA to address its concerns.
   

Shares of Serina Therapeutics (SER) slumped 7% in the pre-market session on Monday after the company announced that the U.S. Food and Drug Administration (FDA) had placed a clinical hold on its application to initiate clinical trials for its advanced Parkinson’s disease therapy candidate.

The agency has requested more information regarding an excipient in the formulation of SER-252, the company said. An excipient is a substance, other than the active pharmaceutical ingredient (API), that is deliberately included in a drug formulation.

Serina noted that the agency’s feedback does not relate to its active drug substance or its proposed action mechanism.

What Are The Steps Forward?

The company said that it intends to work with the FDA to address its concerns. Serina expects to receive the FDA’s formal clinical-hold letter within 30 days and provide an update once it has aligned with the agency on the next steps.

“We appreciate the FDA’s engagement and constructive feedback. We will provide the additional information requested promptly as we continue to move forward in the registrational trial for SER-252.” 
-Steve Ledger, CEO, Serina Therapeutics.

Board Member of Serina and Co-Founder and Executive Chairman of Juvenescence, Greg Bailey, has pledged to continue supporting the company financially and strategically in the initiation of clinical trials for SER-252. The registrational study of SER-252 is designed to evaluate the safety, tolerability, and pharmacokinetics of subcutaneous SER-252 compared to placebo, and will be conducted across sites in the U.S. and Australia.

“This update does not change our conviction in Serina’s long-term potential or our belief in SER-252’s ability to meaningfully improve the lives of patients with advanced Parkinson’s disease,” he added.

How Did Stocktwits Users React?

On Stocktwits, retail sentiment around SER stock stayed within the ‘neutral’ territory over the past 24 hours, while message volume jumped from ‘normal’ to ‘high’ levels.

SER stock is down 0.2% this year and approximately 22% over the past 12 months. 

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