XENE Files NDA for Epilepsy Drug, Falls on Depression Studies' Setback
Xenon Pharmaceuticals submitted an FDA application for azetukalner to treat focal onset seizures, supported by positive phase IIb and phase III epilepsy studies showing significant seizure reductions. However, the company temporarily paused enrollment in depression studies due to neuropsychiatric adverse events, causing a 27% stock decline in premarket trading. The X-NOVA2 depression study is 80% enrolled with top-line data expected in Q1 2027.