NPCE Stock Tumbles Despite Positive One-Year Data From NAUTILUS Trial

By Zacks Equity Research | May 28, 2025, 11:50 AM

NeuroPace NPCE recently announced promising preliminary one-year results from its pivotal NAUTILUS trial, evaluating the RNS System in patients with idiopathic generalized epilepsy (IGE). This study marks a major milestone, as it is the first to assess a brain-responsive neuromodulation system in this patient population.

This development positions NeuroPace as a leader in advancing neuromodulation therapies for generalized epilepsy, a segment historically underserved by current medical technologies. With the successful enrollment and strong retention rates in the NAUTILUS trial, NeuroPace is poised to expand its therapeutic reach and strengthen its clinical value proposition. The findings support ongoing momentum toward a potential FDA submission and reinforce the company’s commitment to innovation in neuroscience and patient-centric care.

Likely Trend of NPCE Stock Following the News

Following the announcement, shares of the company tumbled 28.4% and closed at $12.66 on Tuesday. In the year-to-date period, NPCE’s shares have gained 13.1% against the industry’s 11.2% decline. The S&P 500 decreased 1.8% in the same time frame.

However, the strong one-year data from the NAUTILUS trial positions NeuroPace’s RNS System as a breakthrough solution for idiopathic generalized epilepsy, potentially unlocking access to a large, underserved patient population. This could significantly expand the company’s addressable market, drive long-term revenue growth, and enhance its competitive edge in the neuromodulation space while also supporting future regulatory approvals and payer coverage.

Meanwhile, NPCE currently has a market capitalization of $579.9 million. The company expects its earnings to improve 6.5% in 2025 year over year.

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Details on the NAUTILUS Trial

The NAUTILUS trial is a pivotal, multicenter, randomized, single-blind and sham-stimulation controlled Phase 3 study evaluating the safety and effectiveness of NeuroPace’s RNS System for treating IGE in patients aged 12 and older with drug-resistant seizures. The RNS System, already FDA-approved for focal epilepsy, delivers responsive neurostimulation by detecting abnormal brain activity and providing real-time, targeted stimulation to prevent seizures.

In this study, participants were implanted with the RNS System and randomized to receive either active or sham stimulation, with all participants eventually receiving active treatment after a defined evaluation period. The trial enrolled 87 patients across 23 centers, completing enrollment ahead of schedule, underscoring the significant unmet need in this patient population.

More on the Trial’s One-Year Data

The one-year data from the NAUTILUS trial underscores both the safety and clinical promise of NeuroPace’s RNS System for treating IGE. The study met its primary 12-week post-implant safety endpoint, reporting a low incidence of serious adverse events tied to the device or implantation procedure, consistent with the RNS System's established safety profile from earlier trials. While the overall trial population did not achieve statistical significance for the primary effectiveness endpoint, a prespecified subgroup with lower baseline seizure frequency did show a highly statistically significant and clinically meaningful therapeutic benefit. Though not powered for subgroup analysis, this result suggests that the RNS System may offer targeted effectiveness in a substantial portion of the IGE population.

Further strengthening the case, the entire trial population showed consistent clinical improvements across several meaningful measures. These included a robust median seizure reduction, increased responder rates, and more seizure-free days over the first year of treatment, with improvements continuing for those entering the second year. Remarkably, these gains occurred in a more complex epilepsy subtype, using a novel and ethically grounded study design for implantable devices.

NPCE’s Zacks Rank & Stocks to Consider

NPCE carries a Zacks Rank #3 (Hold) at present.

Some better-ranked stocks in the broader medical space that have announced quarterly results are CVS Health Corporation CVS, Integer Holdings Corporation ITGR and AngioDynamics ANGO.

CVS Health, carrying a Zacks Rank of 2 (Buy), reported first-quarter 2025 adjusted earnings per share (EPS) of $2.25, beating the Zacks Consensus Estimate by 31.6%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Revenues of $94.59 billion outpaced the consensus mark by 1.8%. CVS Health has a long-term estimated growth rate of 11.4%. Its earnings surpassed estimates in each of the trailing four quarters, with an average surprise of 18.1%.

Integer Holdings reported first-quarter 2025 adjusted EPS of $1.31, beating the Zacks Consensus Estimate by 3.2%. Revenues of $437.4 million surpassed the Zacks Consensus Estimate by 1.3%. It currently sports a Zacks Rank of 1.

Integer Holdings has a long-term estimated growth rate of 18.4%. ITGR’s earnings surpassed estimates in three of the trailing four quarters and missed once, the average surprise being 2.8%.

AngioDynamics, currently sporting a Zacks Rank #1, reported a third-quarter fiscal 2025 adjusted EPS of 3 cents against the Zacks Consensus Estimate of a 13-cent loss. Revenues of $72 million beat the Zacks Consensus Estimate by 2%.

ANGO has an estimated fiscal 2026 earnings growth rate of 27.8% compared with the S&P 500 Composite’s 10.5% growth. AngioDynamics’ earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 70.9%.

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AngioDynamics, Inc. (ANGO): Free Stock Analysis Report
 
CVS Health Corporation (CVS): Free Stock Analysis Report
 
Integer Holdings Corporation (ITGR): Free Stock Analysis Report
 
NeuroPace, Inc. (NPCE): Free Stock Analysis Report

This article originally published on Zacks Investment Research (zacks.com).

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