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

Neurogene Inc.

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.

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