FDA Events for NeuroPace (NPCE)
This section highlights FDA-related milestones and regulatory updates for drugs developed by NeuroPace (NPCE).
Over the past two years, NeuroPace has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
RNS. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
RNS System - FDA Regulatory Timeline and Events
RNS System is a drug developed by NeuroPace for the following indication: Drug-resistant idiopathic generalized epilepsy.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- RNS System
- Announced Date:
- April 8, 2025
- Indication:
- Drug-resistant idiopathic generalized epilepsy
Announcement
NeuroPace, Inc. announced three-year effectiveness data from the Post-Approval Study (PAS) of the RNS® System, which showed an 82% median reduction in seizures in adults treated with brain-responsive stimulation for drug-resistant focal epilepsy (DRE).1
AI Summary
NeuroPace, Inc. recently announced exciting three-year data from its Post-Approval Study (PAS) of the RNS® System, the largest FDA-reviewed neuromodulation study in drug-resistant focal epilepsy. The study, which enrolled 324 patients, showed a median seizure reduction of 82% at three years in adults treated with brain-responsive stimulation. In addition, 42% of patients achieved seizure freedom for at least six months, while rapid improvements were seen with a 62% median reduction in seizures at six months. These results highlight the continued effectiveness and safety of the RNS System, reinforcing its role as the only FDA-approved device that provides personalized, real-time brain-responsive neurostimulation for drug-resistant epilepsy. Presenting these findings at the American Academy of Neurology Annual Meeting, NeuroPace’s study adds valuable evidence supporting the use of targeted neuromodulation to improve the quality of life for patients with drug-resistant focal epilepsy.
Read Announcement- Drug:
- RNS System
- Announced Date:
- February 3, 2025
- Indication:
- Drug-resistant idiopathic generalized epilepsy
Announcement
NeuroPace, Inc announced that an abstract featuring data from the Post-approval Study of the RNS System has been selected for an oral presentation at the upcoming American Academy of Neurology (AAN) 2025 Annual Meeting, which is being held April 5th – 9th in San Diego.
AI Summary
NeuroPace, Inc. recently announced that an abstract featuring data from the Post-approval Study of the RNS System has been selected for an oral presentation at the American Academy of Neurology (AAN) 2025 Annual Meeting. This abstract focuses on evaluating the effectiveness of the RNS System in treating focal epilepsy.
Dr. Dawn Eliashiv, a respected professor of neurology and co-director at the UCLA Seizure Disorders Center, will present the study during session S20, titled "Multicenter Post-approval Study of the RNS System in Focal Epilepsy." The presentation is scheduled for Monday, April 7th at 5:06 PM PT at the meeting held in San Diego from April 5th through April 9th. This presentation underlines the potential of the RNS System to provide personalized treatment and improved outcomes for people living with epilepsy.
Read Announcement- Drug:
- RNS System
- Announced Date:
- December 3, 2024
- Indication:
- Drug-resistant idiopathic generalized epilepsy
Announcement
NeuroPace, Inc. announced completion of enrollment and implant procedures in its feasibility investigational device exemption (IDE) study of the RNS® System for the treatment of Lennox-Gastaut Syndrome (LGS), a devastating form of childhood-onset epilepsy characterized by cognitive dysfunction and frequent generalized onset seizures that often lead to injury.
AI Summary
NeuroPace, Inc. announced that it has completed enrollment and the implant procedures in its feasibility investigational device exemption (IDE) study using the RNS® System for treating Lennox-Gastaut Syndrome (LGS). LGS is a severe form of childhood-onset epilepsy that leads to cognitive challenges and frequent generalized seizures, which often cause injury. The study enrolled 20 patients aged 12 and older with drug-resistant generalized seizures to evaluate whether brain-responsive neurostimulation can help manage LGS. The research is supported by a $9.3 million grant from the National Institutes of Health through the BRAIN Initiative. Although the RNS System is already known for its safety and effectiveness in treating focal onset seizures in adults, this study aims to explore its potential to improve treatment outcomes for patients with LGS. The team now looks forward to gathering valuable data that may guide future research and treatment options for LGS.
Read Announcement
NeuroPace FDA Events - Frequently Asked Questions
As of now, NeuroPace (NPCE) has not received any FDA approvals for its therapy in the last two years.
In the past two years, NeuroPace (NPCE) has reported FDA regulatory activity for RNS System.
The most recent FDA-related event for NeuroPace occurred on April 8, 2025, involving RNS System. The update was categorized as "Data," with the company reporting: "NeuroPace, Inc. announced three-year effectiveness data from the Post-Approval Study (PAS) of the RNS® System, which showed an 82% median reduction in seizures in adults treated with brain-responsive stimulation for drug-resistant focal epilepsy (DRE).1"
Currently, NeuroPace has one therapy (RNS System) targeting the following condition: Drug-resistant idiopathic generalized epilepsy.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:NPCE) was last updated on 7/10/2025 by MarketBeat.com Staff
