NeuroPace Inc NPCE
NeuroPace Inc (Nasdaq: NPCE) is a CNS/neurology/psychiatry medical device company.
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| RNS System (PMA-approved, adult drug-resistant focal epilepsy) | Drug-resistant focal epilepsy | — | NA_NON_THERAPEUTIC |
| RNS System label expansion PMA-S (NAUTILUS) | Drug-resistant idiopathic generalized epilepsy | — | NA_NON_THERAPEUTIC |
| RNS System pediatric focal epilepsy label expansion (RESPONSE / NEST real-world data) | Focal epilepsy ages 12-17 | — | NA_NON_THERAPEUTIC |
Recent results and decisions
- Jul 28, 2026CRL FDA told NeuroPace the PMA Supplement for IGE indication expansion is not approvable in its current form and requested additional NAUTILUS evidence; company will file a Submission Issue Request.
NeuroPace has received a communication from FDA indicating that the PMA Supplement is not approvable in its current form.
Filing - Jul 28, 2026positive NAUTILUS: 77% median GTC seizure reduction and 40% GTC seizure freedom at 18 months; 24-month evaluable patients with 23 of 24 months of stimulation had 100% median GTC reduction.
At 18 months, patients treated with the RNS System experienced a 77% median reduction in GTC seizures compared with baseline, and 40% of patients experienced GTC seizure freedom at that timepoint.
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other CNS/neurology/psychiatry companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.