FDA feedback supports registrational trial for SER-252 in advanced Parkinson's under 505(b)(2) NDA pathway

Serina Therapeutics, Inc.

FDA Type B meeting written feedback supports advancing SER-252 (POZ-apomorphine) in registrational study.
Plans to submit U.S. IND in Q4 2025; patient dosing in Australia expected to start in Q4 2025.
U.S. enrollment expected to begin in Q1 2026 after IND clearance.
SER-252-1b study is randomized, double-blind, placebo-controlled Phase 1b with up to 88 patients.
CEO highlights capital-efficient 505(b)(2) pathway; platform may apply to other POZ-enabled small molecules.

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