Why Is NeuroPace Stock Falling After Epilepsy Treatment Study Data?

NeuroPace, Inc. NPCE released preliminary primary endpoint one-year results of the two-year NAUTILUS study evaluating safety and effectiveness of the RNS System for drug-resistant idiopathic generalized epilepsy (IGE).

The study met its primary 12-week post-implant safety endpoint, demonstrating a low rate of serious adverse events related to the device and implant procedure.

The study did not reach statistical significance for the primary effectiveness endpoint in the overall study population, which was to show a longer time to a second generalized tonic-clonic seizure in the active stimulation group compared to the sham stimulation group.

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However, the data did show a clinically meaningful and statistically significant response in the primary effectiveness endpoint within a subgroup of patients with lower baseline frequency of generalized tonic-clonic seizures, representing most trial participants.

Additionally, the company said that within the entire trial population, clinically relevant data, including median percent seizure reduction, responder rates, and improvement in seizure-free days, showed numerically robust and clinically meaningful improvements over the first year of treatment and continued in those who have progressed to the second year.

The company will engage with the FDA to discuss regulatory pathways based on the data.

These discussions may include the possibility of utilizing the overall median seizure reduction data across the full study population and pursuing a more targeted indication focused on patients with lower baseline seizure frequency who may represent a majority of IGE patients.

In April, NeuroPaces terminated its distribution relationship for SEEG products and will begin winding down the relationship in the fourth quarter of 2025 and continuing through the first quarter of 2026.

NeuroPace announced three-year effectiveness data from the Post-Approval Study (PAS) of the RNS System in April.

The data showed an 82% median reduction in seizures in adults treated with brain-responsive stimulation for drug-resistant focal epilepsy and seizure freedom, with 42% of patients remaining seizure-free for 6+ months.

Sales grew 24% to $22.5 million in the first quarter of 2025. RNS System revenue grew 29%, excluding revenue from implants in the NAUTILUS study in the first quarter of 2024.

Increased sales of the RNS System primarily drove the company’s revenue growth. The company also continued to generate meaningful revenue from sales of SEEG products.

NeuroPace raised the fiscal year 2025 sales guidance from $92 million-$96 million to $93 million-$97 million compared to the consensus of $93.64 million.

Price Action: NPCE stock is down 33.90% at $11.68 at the last check Tuesday.

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