NeuroPace Faces FDA Delay on IGE Expansion

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โดย Zacks Investment Research·US·Read original
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NeuroPace has hit a regulatory delay in its bid to expand the RNS System into idiopathic generalized epilepsy, or IGE, after the FDA said its premarket approval supplement was not approvable in its current form. The agency requested more information on clinical benefit across patient subgroups, including by baseline generalized tonic-clonic seizure frequency, and on the clinical meaningfulness of reducing those seizures. Management said the response was not a disapproval and that discussions remained interactive, with questions unrelated to safety. NeuroPace is pursuing the FDA's Submission Issue Request process before amending the filing, and the planned response may include additional subgroup analyses, patient- and physician-reported outcomes, published and real-world evidence, and longer-term NAUTILUS data showing a 100% median reduction in GTC seizures at 24 months. Second-quarter RNS System revenues rose 21.3% year over year to $22.5 million, with record active prescribers, active accounts, and patient pipeline, while the company's 2026 revenue guidance excludes any IGE contribution.

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Brain-Computer Interface▼ · 2 stocks
Neuropace Inc
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FDA requests more information on IGE expansion, delaying approval

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