---
schema_version: "secwatch.filing_event.v1"
accession: "0001404644-25-000088"
form_type: "8-K"
ticker: "NGNE"
cik: "0001404644"
company_name: "Neurogene Inc."
filed_at: "2025-10-09T23:59:59+00:00"
generated_at: "2026-05-17T04:10:19.305990+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Neurogene FDA agreement on Rett gene therapy registrational trial; Q4 2025 dosing start

## Summary
- Completed FDA discussions on Embolden registrational trial protocol for NGN-401; first participant dosing planned in Q4 2025 across 13 U.S. sites.
- New preclinical NHP data shows ICV delivery achieves superior brain biodistribution vs. IT-L at clinically relevant 1E15 vg dose; supports ICV route.
- Phase 1/2 data: first 4 participants gained 23 developmental milestones across multiple domains, indicating multi-domain improvement.
- ICV and IT-L show comparable peripheral organ transduction; no liver-sparing benefit to IT-L administration.

## SEC filing metadata
- accession: 0001404644-25-000088
- form_type: 8-K
- ticker: NGNE
- cik: 0001404644
- company_name: Neurogene Inc.
- filed_at: 2025-10-09T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1404644/000140464425000088/0001404644-25-000088-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1404644/000140464425000088/ngne-20251009.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001404644-25-000088
- JSON: https://secwatch.observer/filing/0001404644-25-000088.json
- Plain text: https://secwatch.observer/filing/0001404644-25-000088.txt

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