Xenon submits azetukalner NDA for focal seizures, reports Q3 2026 results

Xenon Pharmaceuticals announced that it submitted its New Drug Application for azetukalner in focal seizures to the U.S. Food & Drug Administration in September 2026.¹ The company did not state that the application has entered FDA review.

On the epilepsy side, Xenon said it expects to initiate X-FIRST, a new Phase 3b/4 study evaluating azetukalner as a first adjunctive antiseizure medication, with the study planned for initiation in the first quarter of 2027.¹ The ongoing Phase 3 X-TOLE3 study continues to enroll and is intended to support regulatory submissions outside the U.S., with enrollment outside Japan expected to complete in 2026.¹ The Phase 3 X-ACKT study in primary generalized tonic-clonic seizures continues to enroll and is intended to support regulatory submissions for an additional epilepsy indication.¹

In neuropsychiatry, Xenon said it completed enrollment in the Phase 3 X-NOVA2 study in major depressive disorder with approximately 360 total patients, with topline data now expected in December 2026.¹ The company had earlier announced in September a voluntary pause on new patient enrollment in its ongoing Phase 3 studies of azetukalner in MDD and bipolar depression, while patients already enrolled, including in open label extension studies, remain active.¹

In pain research, Xenon presented positive Phase 1 data at the IASP 2026 World Congress on Pain for XEN1701, which achieved its target profile including high NaV1.7 receptor occupancy in both peripheral and central nervous systems and was generally well-tolerated.¹ It also presented positive Phase 1 data for XEN1120 targeting KV7, which achieved plasma levels predictive of analgesic effects and was generally well-tolerated.¹ Based on these results, Xenon expects to initiate Phase 2 proof-of-concept studies for both XEN1701 and XEN1120 in acute pain in the first half of 2027.¹

On finances, Xenon reported cash, cash equivalents and marketable securities of $1,153.5 million as of September 30, 2026, compared to $586.0 million as of December 31, 2025,¹ and said it anticipates having sufficient cash to fund operations into 2029.¹