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

Issuer:     Neurogene Inc. (NGNE)
CIK:        0001404644
Form:       8-K
Filed at:   2025-11-06T23:59:59+00:00
Accession:  0001404644-25-000091
Event type: other_material
Sentiment:  positive
Materiality: 0.70
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Neurogene doses first participant in Embolden registrational trial of NGN-401 for Rett syndrome
--------------------------------------------------------------------------------

- First participant dosed in single-arm, open-label, baseline-controlled registrational trial of NGN-401 gene therapy for Rett syndrome.
- Trial targets 20 females ages 3+; enrollment expected to complete in 3-6 months.
- 12 of 13 clinical sites initiated; trial designed to support future BLA submission.
- Company to present Phase 1/2 interim data at Stifel Healthcare Conference on November 12, 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1404644/000140464425000091/0001404644-25-000091-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1404644/000140464425000091/ngne-20251106.htm
  HTML page:      https://secwatch.observer/filing/0001404644-25-000091

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