NeuroPace says FDA deems IGE indication filing not approvable in its current form
NeuroPace received an FDA communication that its Premarket Approval Supplement to expand the RNS System indication to drug-resistant idiopathic generalized epilepsy is not approvable as submitted, and FDA has requested additional clinical evidence. The company says it will file a Submission Issue Request and amend the submission, and that its guidance does not include any contribution from the expanded indication.
Key points
- FDA communication was received on the PMA-S target due date, and the company says it has begun working with FDA on the review team and a subsequent SIR meeting.
- FDA requested additional clinical evidence from the NAUTILUS trial and literature supporting the submission.
- At 18 months, patients treated with the RNS System had a 77% median reduction in GTC seizures from baseline, and 40% achieved GTC seizure freedom.
- Full second quarter 2026 results and any full year outlook updates are scheduled for the August 11, 2026 earnings call.
The filing
Written by AI on Nov 9, 2026, 8:38 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on July 28, 2026.
Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.