---
schema_version: "secwatch.filing_event.v1"
accession: "0001708599-25-000126"
form_type: "8-K"
ticker: "SER"
cik: "0001708599"
company_name: "Serina Therapeutics, Inc."
filed_at: "2025-11-03T23:59:59+00:00"
generated_at: "2026-05-17T00:54:34.085481+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Serina Therapeutics announces FDA clinical hold on SER-252 IND for advanced Parkinson's disease

## Summary
- FDA placed clinical hold on SER-252 IND, requesting additional info on a commonly used excipient; not related to active drug or mechanism.
- Serina expects formal clinical-hold letter within 30 days and will work expeditiously with FDA to address requests.
- FDA previously indicated support for SER-252 development under 505(b)(2) NDA pathway; CEO remains confident in program.
- SER-252 is Serina's lead program for advanced Parkinson's; Phase 1b trial designed as randomized, double-blind, placebo-controlled.

## SEC filing metadata
- accession: 0001708599-25-000126
- form_type: 8-K
- ticker: SER
- cik: 0001708599
- company_name: Serina Therapeutics, Inc.
- filed_at: 2025-11-03T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1708599/000170859925000126/0001708599-25-000126-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1708599/000170859925000126/ser-20251103.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001708599-25-000126
- JSON: https://secwatch.observer/filing/0001708599-25-000126.json
- Plain text: https://secwatch.observer/filing/0001708599-25-000126.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.