Serina submits complete response to FDA clinical hold for SER-252 Parkinson's program

Serina Therapeutics, Inc.

Complete response submitted Dec 9, 2025, addressing FDA's clinical hold on SER-252 related to trehalose excipient.
Submission includes detailed data package on trehalose as subcutaneous excipient and revised protocol for SAD phase.
FDA clinical hold does not involve apomorphine drug substance, mechanism of action, enFuse device, or 505(b)(2) pathway.
Global site start-up continues; first-patient-in for Phase 1b registrational study targeted for Q1 2026, subject to hold resolution.
Company acknowledges FDA's engagement and expects SAD phase initiation in Q1 2026 pending regulatory and ethics approvals.

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