NeuroPace Files PMA Supplement to FDA Seeking Expanded RNS® System Indication for Idiopathic Generalized Epilepsy
Neuropace, Inc. (NPCE)
Company Research
Source: Business Wire
-- Submission supported by positive preliminary 18-month NAUTILUS data in patients with drug-resistant idiopathic generalized epilepsy (IGE) and generalized tonic-clonic (GTC) seizures -- MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--NeuroPace, Inc. (Nasdaq: NPCE), a medical device company focused on transforming the lives of people living with epilepsy, today announced that it has filed a Premarket Approval Supplement (PMA-S) application to the U.S. Food and Drug Administration (FDA) seeking to expand the labeled indication for its RNS® System to include patients with antiseizure-medication (ASM) resistant idiopathic generalized epilepsy (IGE) with generalized tonic-clonic seizures.The PMA-S is supported by positive preliminary results from the NAUTILUS trial, which demonstrated robust 77% median GTC seizure reduction and a favorable safety profile in this highly refractory patient population at 18 months of therapy. The RNS System has been granted Breakthrough Device Designation for th
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News
- NeuroPace (NASDAQ:NPCE) had its price target raised by analysts at UBS Group AG from $18.00 to $22.00. They now have a "buy" rating on the stock.MarketBeat
- NeuroPace (NASDAQ:NPCE) had its "sell (e+)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
- NeuroPace (NASDAQ:NPCE) had its price target raised by analysts at JPMorgan Chase & Co. from $18.00 to $20.00. They now have an "overweight" rating on the stock.MarketBeat
- NeuroPace (NASDAQ:NPCE) had its "buy" rating reaffirmed by analysts at UBS Group AG.MarketBeat
- NeuroPace Announces Positive 18-Month NAUTILUS Trial Results in Idiopathic Generalized EpilepsyBusiness Wire
NPCE
Earnings
- 11/4/25 - Beat
NPCE
Sec Filings
- 12/15/25 - Form 144
- 12/4/25 - Form 4
- 12/1/25 - Form 4
- NPCE's page on the SEC website