secwatch.observer — SEC 8-K summary
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Issuer:     Neurogene Inc. (NGNE)
CIK:        0001404644
Form:       8-K
Filed at:   2024-11-18T23:59:59+00:00
Accession:  0001404644-24-000097
Event type: other_material
Sentiment:  negative
Materiality: 0.90
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1404644/000140464424000097/0001404644-24-000097-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1404644/000140464424000097/ngne-20241118.htm
  HTML page:      https://secwatch.observer/filing/0001404644-24-000097

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