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NeuroPace (NPCE) FDA Events

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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.

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

  • 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
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