---
schema_version: "secwatch.filing_event.v1"
accession: "0001404644-26-000006"
form_type: "8-K"
ticker: "NGNE"
cik: "0001404644"
company_name: "Neurogene Inc."
filed_at: "2026-02-26T23:59:59+00:00"
generated_at: "2026-05-15T23:29:52.381114+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Neurogene's NGN-401 receives FDA Breakthrough Therapy designation for Rett syndrome

## Summary
- FDA granted Breakthrough Therapy designation for NGN-401, a gene therapy for Rett syndrome.
- Designation based on interim Phase 1/2 data showing clinically meaningful, durable multidomain improvements.
- Completion of dosing in Embolden registrational trial expected Q2 2026.
- Company plans to present additional interim Phase 1/2 data in mid-2026.
- NGN-401 also has RMAT, Rare Pediatric Disease designations; part of FDA START Pilot Program.

## SEC filing metadata
- accession: 0001404644-26-000006
- form_type: 8-K
- ticker: NGNE
- cik: 0001404644
- company_name: Neurogene Inc.
- filed_at: 2026-02-26T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1404644/000140464426000006/0001404644-26-000006-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1404644/000140464426000006/ngne-20260226.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001404644-26-000006
- JSON: https://secwatch.observer/filing/0001404644-26-000006.json
- Plain text: https://secwatch.observer/filing/0001404644-26-000006.txt

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