---
schema_version: "secwatch.filing_event.v1"
accession: "0001404644-24-000059"
form_type: "8-K"
ticker: "NGNE"
cik: "0001404644"
company_name: "Neurogene Inc."
filed_at: "2024-06-03T23:59:59+00:00"
generated_at: "2026-06-01T06:45:09.449395+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Neurogene's NGN-401 Rett syndrome gene therapy selected for FDA START Pilot Program

## Summary
- NGN-401 one of only three CBER programs chosen for FDA's START Pilot Program.
- START provides enhanced communications with FDA to accelerate development of rare disease therapies.
- Phase 1/2 trial of NGN-401 ongoing; favorable safety data from first three patients reported.
- Interim efficacy data from the trial expected in Q4 2024.
- Company aims to advance NGN-401 toward potential registrational study.

## SEC filing metadata
- accession: 0001404644-24-000059
- form_type: 8-K
- ticker: NGNE
- cik: 0001404644
- company_name: Neurogene Inc.
- filed_at: 2024-06-03T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1404644/000140464424000059/0001404644-24-000059-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1404644/000140464424000059/ngne-20240603.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001404644-24-000059
- JSON: https://secwatch.observer/filing/0001404644-24-000059.json
- Plain text: https://secwatch.observer/filing/0001404644-24-000059.txt

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