---
schema_version: "secwatch.filing_event.v1"
accession: "0001404644-24-000109"
form_type: "8-K"
ticker: "NGNE"
cik: "0001404644"
company_name: "Neurogene Inc."
filed_at: "2024-11-21T23:59:59+00:00"
generated_at: "2026-05-29T20:31:13.181145+00:00"
event_type: "other_material"
sentiment: "negative"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# Neurogene patient dies after high-dose NGN-401; FDA allows trial to continue at lower dose

## Summary
- Patient dosed Nov 5 with 3E15 vg NGN-401 died from hyperinflammatory syndrome linked to high AAV exposure.
- FDA permitted Phase 1/2 trial to continue using 1E15 vg dose for pediatric and adolescent/adult cohorts.
- Neurogene will incorporate the 1E15 vg dose into future registrational trial design.
- This is the same patient previously reported as critical; hyperinflammatory syndrome is rare and life-threatening.

## SEC filing metadata
- accession: 0001404644-24-000109
- form_type: 8-K
- ticker: NGNE
- cik: 0001404644
- company_name: Neurogene Inc.
- filed_at: 2024-11-21T23:59:59+00:00
- event_type: other_material
- sentiment: negative
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 7.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1404644/000140464424000109/0001404644-24-000109-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1404644/000140464424000109/ngne-20241120.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001404644-24-000109
- JSON: https://secwatch.observer/filing/0001404644-24-000109.json
- Plain text: https://secwatch.observer/filing/0001404644-24-000109.txt

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