NeuroPace: IGE Application Not Approvable in Its Current Form, Though There‘s Still a Path to Indication Expansion

Research evidence excerpt

NeuroPace: IGE Application Not Approvable in Its Current Form, Though There‘s Still a Path to Indication Expansion

J P M O R G A N North America Equity Research

28 July 2026

NeuroPace Overweight

NPCE, NPCE US

IGE Application Not Approvable in Its Current Form, Price (28 Jul 26):$15.31

Though There’s Still a Path to Indication Expansion

Medical Supplies & Devices

NeuroPace announced that it received communication from the FDA that its PMA Lilia-Celine B Lozada AC

supplement for indication expansion into idiopathic generalized epilepsy (IGE) is (1-212) 622-1019

not approvable in its current form. We think the FDA is taking a closer look as lilia-celine.b.lozada@jpmchase.com

NAUTILUS was the first study to evaluate a device in drug-resistant IGE patients, Robbie Marcus, CFA

who look very different than focal patients do with regard to seizure frequency and (1-212) 622-6657

severity. The FDA is requesting more data regarding various subgroup analyses robert.j.marcus@jpmorgan.com

and the clinical meaningfulness of seizure reduction, along with the complete 24- Allen Gong

month NAUTILUS data set, all of which NeuroPace either has on hand or is (1-212) 622-9520

allen.gong@jpmorgan.com

available in other published literature (i.e., no new trial is needed). Importantly, the

Henry Householter

decision was not based on any safety concerns, and the FDA highlighted that it did (1-212) 464-5599

not issue an outright denial, meaning an approval is still on the table, albeit on a later henry.householter@jpmorgan.com

timeline than initially anticipated. Depending on whether the FDA restarts the 180 J.P. Morgan Securities LLC

day clock, approval could come between later this year and mid-2027, though this

shouldn’t impact numbers in a meaningful way — label expansion was not