secwatch.observer — SEC 8-K summary
======================================

Issuer:     Neurogene Inc. (NGNE)
CIK:        0001404644
Form:       8-K
Filed at:   2024-11-21T23:59:59+00:00
Accession:  0001404644-24-000109
Event type: other_material
Sentiment:  negative
Materiality: 0.90
Item codes: 7.01
LLM model:  deepseek-v4-flash:cloud@v2

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

- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1404644/000140464424000109/0001404644-24-000109-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1404644/000140464424000109/ngne-20241120.htm
  HTML page:      https://secwatch.observer/filing/0001404644-24-000109

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer