NeuroPace Inc 8K

NeuroPace received FDA feedback that its PMA supplement to expand the RNS System’s indication to idiopathic generalized epilepsy is not currently approvable, and the company will provide additional clinical data and work with the agency on a revised path to approval.

On July 28, 2026, NeuroPace, Inc. announced that the U.S. Food and Drug Administration informed the company that its Premarket Approval Panel Track Supplement seeking to expand the labeled indication for the RNS System to treat antiseizure medication‑resistant idiopathic generalized epilepsy is not approvable in its current form, requesting additional clinical evidence and context from the NAUTILUS trial and related literature. NeuroPace has already met with the FDA, plans to submit a Submission Issue Request to further discuss the agency’s questions, and intends to amend its filing with supplemental data, including 18‑ and 24‑month NAUTILUS results that demonstrate substantial reductions in generalized tonic‑clonic and other seizure types and strong patient and physician‑reported improvements. The company emphasized it still believes a path to approval exists, highlighted that its current financial guidance does not assume any contribution from the potential indication expansion, and scheduled a conference call on July 28, 2026, to discuss the FDA communication, with full second quarter 2026 results and any outlook updates to be provided on August 11, 2026.

Filing Facts

CIK

1528287

Ticker

-

Form

8K

Source Type

sec

Accession

0001193125-26-321083

Alert Tier

6