Neurocrine BiosciencesXENE

Neurocrine Biosciences (XENE) focuses on neurology and psychiatry. The company is developing azetukalner, a Phase 3 drug, for various neurological and psychiatric conditions. An NDA submission for azetukalner in FOS is anticipated in Q3 2026 in the U.S.

In the X-TOLE2 study, azetukalner demonstrated a median percent change (MPC) in monthly FOS frequency from baseline to week 12 of -53.2% for the 25 mg dose and -34.5% for the 15 mg dose, compared to -10.4% for placebo. The placebo-adjusted MPC in monthly FOS frequency was -42.7% in the X-TOLE2 study. The primary efficacy endpoint for the X-TOLE2 and X-TOLE3 studies is the median percent change in monthly seizure frequency from baseline through the 12-week double-blind period.

The X-NOVA MDD program, a multicenter, randomized, double-blind, placebo-controlled study, is evaluating azetukalner at a 20 mg dose over a 6-week double-blind period, with an open-label extension of up to 12 months. This program has approximately 450 enrolled patients, and its primary efficacy endpoint is the change from baseline in the HAM-D17 score at week 6. The X-CEED BPD program, also a multicenter, randomized, double-blind, placebo-controlled study, is investigating azetukalner at a 20 mg dose over a 6-week double-blind period, with an open-label extension of up to 12 months. This program has approximately 400 enrolled patients, and its primary efficacy endpoint is the change from baseline in the MADRS score at week 6. Topline data from the X-NOVA2 study in MDD is expected in H1 2027.