---
schema_version: "secwatch.filing_event.v1"
accession: "0001404644-24-000097"
form_type: "8-K"
ticker: "NGNE"
cik: "0001404644"
company_name: "Neurogene Inc."
filed_at: "2024-11-18T23:59:59+00:00"
generated_at: "2026-05-29T22:57:14.494633+00:00"
event_type: "other_material"
sentiment: "negative"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# Neurogene reports serious hyperinflammatory syndrome in high-dose NGN-401 patient; high-dose cohort halted

## Summary
- Patient dosed on Nov 5 with 3E15 vg dose developed life-threatening systemic hyperinflammatory syndrome; is in critical condition.
- FDA allowed trial to continue with low-dose cohort (1E15 vg); no other treatment-related SAEs to date.
- Five participants in 1E15 vg cohort had only mild AEs; no MeCP2 overexpression or ICV procedure-related AEs.
- Neurogene paused high-dose enrollment and no longer expects to complete low-dose enrollment in Q4 2024 due to protocol updates.
- Company proactively engaged FDA via START program; high-dose cohort permanently discontinued.

## SEC filing metadata
- accession: 0001404644-24-000097
- form_type: 8-K
- ticker: NGNE
- cik: 0001404644
- company_name: Neurogene Inc.
- filed_at: 2024-11-18T23:59:59+00:00
- event_type: other_material
- sentiment: negative
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1404644/000140464424000097/0001404644-24-000097-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1404644/000140464424000097/ngne-20241118.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001404644-24-000097
- JSON: https://secwatch.observer/filing/0001404644-24-000097.json
- Plain text: https://secwatch.observer/filing/0001404644-24-000097.txt

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