---
schema_version: "secwatch.filing_event.v1"
accession: "0001404644-24-000083"
form_type: "8-K"
ticker: "NGNE"
cik: "0001404644"
company_name: "Neurogene Inc."
filed_at: "2024-08-07T23:59:59+00:00"
generated_at: "2026-05-31T11:40:26.344929+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Neurogene receives FDA RMAT designation for NGN-401 gene therapy in Rett syndrome

## Summary
- RMAT designation based on preliminary clinical evidence from ongoing Phase 1/2 trial showing potential to address unmet medical needs.
- Designation provides Fast Track, Breakthrough Therapy benefits, and eligibility for Accelerated Approval and Priority Review.
- NGN-401 previously selected for FDA START Pilot Program; interim low-dose efficacy data expected Q4 2024, high-dose data H2 2025.
- CEO notes FDA commitment to expedite development; designation underscores therapeutic potential of NGN-401.

## SEC filing metadata
- accession: 0001404644-24-000083
- form_type: 8-K
- ticker: NGNE
- cik: 0001404644
- company_name: Neurogene Inc.
- filed_at: 2024-08-07T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1404644/000140464424000083/0001404644-24-000083-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1404644/000140464424000083/ngne-20240807.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001404644-24-000083
- JSON: https://secwatch.observer/filing/0001404644-24-000083.json
- Plain text: https://secwatch.observer/filing/0001404644-24-000083.txt

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