Serina noted that the agency’s feedback does not relate to its active drug substance or its proposed action mechanism.
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.
The company added that it intends to work with the FDA to address its concerns.
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