Morningstar

NeuroPace's Panel Track Supplement Not Approvable in Current Form, FDA Says

Provided by Dow Jones

By Doc Louallen 




  The U.S. Food and Drug Administration told NeuroPace it cannot yet approve the company's Premarket Approval Panel Track Supplement to expand the label indication for its brain implant for a hard-to-treat form of epilepsy. 



  NeuroPace has met with the FDA and will submit a submission issue request for its RNS System. 



  At 18 months, patients treated with the RNS System had a 77% median reduction in generalized tonic-clonic seizures versus baseline, and 40% were free of those seizures at that time. 



  At the FDA's request, NeuroPace also provided data over two years showing continued improvement among evaluable patients who received stimulation for 23 of 24 months post-implant. 



  Shares fell about 15% to $12.99 in afterhours trading. The stock is down about 9% over the past three months. 





  Write to Doc Louallen at Doc.Louallen@wsj.com 





  (END) Dow Jones Newswires



  July 28, 2026 18:29 ET (22:29 GMT)


Copyright (c) 2026 Dow Jones & Company, Inc.
  

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