---
schema_version: "secwatch.filing_event.v1"
accession: "0001404644-25-000091"
form_type: "8-K"
ticker: "NGNE"
cik: "0001404644"
company_name: "Neurogene Inc."
filed_at: "2025-11-06T23:59:59+00:00"
generated_at: "2026-05-16T23:34:50.508976+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Neurogene doses first participant in Embolden registrational trial of NGN-401 for Rett syndrome

## Summary
- First participant dosed in single-arm, open-label, baseline-controlled registrational trial of NGN-401 gene therapy for Rett syndrome.
- Trial targets 20 females ages 3+; enrollment expected to complete in 3-6 months.
- 12 of 13 clinical sites initiated; trial designed to support future BLA submission.
- Company to present Phase 1/2 interim data at Stifel Healthcare Conference on November 12, 2025.

## SEC filing metadata
- accession: 0001404644-25-000091
- form_type: 8-K
- ticker: NGNE
- cik: 0001404644
- company_name: Neurogene Inc.
- filed_at: 2025-11-06T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1404644/000140464425000091/0001404644-25-000091-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1404644/000140464425000091/ngne-20251106.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001404644-25-000091
- JSON: https://secwatch.observer/filing/0001404644-25-000091.json
- Plain text: https://secwatch.observer/filing/0001404644-25-000091.txt

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