NeuroPace shares surge 10.84% premarket after positive 18-month NAUTILUS trial results and FDA submission plans.

NeuroPace (NPCE) surged 10.84% in premarket trading following the announcement of positive 18-month results from its NAUTILUS trial for the RNS System in treating drug-resistant idiopathic generalized epilepsy. The trial demonstrated a 77% median reduction in generalized tonic-clonic (GTC) seizures compared to baseline (p<0.001), with sustained efficacy and strong clinical endorsement. The company reiterated its plan to submit a PMA supplement to the FDA for IGE indication expansion by year-end 2025, reinforcing its potential to secure the first neuromodulation therapy for this patient population. The data, presented at the American Epilepsy Society meeting, underscored the RNS System’s risk-benefit profile and therapeutic impact, driving premarket optimism.