Xenon reports Q2 2026 results, confirms azetukalner NDA submission on track for Q3

Xenon Pharmaceuticals reported financial results for the quarter ended June 30, 2026 on August 6, 2026. Xenon remains on track to submit its New Drug Application for azetukalner in focal onset seizures in the third quarter of 2026, having completed a pre-NDA meeting with the FDA.¹

On the epilepsy program, the Phase 3 X-TOLE3 study of azetukalner in FOS continues to enroll and is intended to support regulatory submissions outside the United States, with enrollment outside Japan expected to complete in 2026.¹ The Phase 3 X-ACKT study of azetukalner in PGTCS continues to enroll and is intended to support regulatory submissions for an additional epilepsy indication.¹

In neuropsychiatry, patient recruitment continues for the Phase 3 "X-NOVA2" and "X-NOVA3" trials in major depressive disorder, and topline data from X-NOVA2 are expected in the first half of 2027.¹ Enrollment is also ongoing in the Phase 3 X-CEED study evaluating azetukalner in patients with bipolar depression I or II.¹

On pain programs, a Phase 1 study of XEN1701 targeting NaV1.7 is ongoing, with completion expected in the second half of 2026 to support a Phase 2 proof-of-concept study in acute pain.¹ Xenon also received approval of a Clinical Trial Application for a second NaV1.7 candidate, XEN1720, and its Phase 1 study is now underway.¹

Financially, cash, cash equivalents and marketable securities were $1,245.1 million as of June 30, 2026, up from $586.0 million at the end of 2025, and the company said it expects this to fund operations into 2029.¹ Research and development expenses were $99.2 million for the quarter, compared to $75.0 million a year earlier.¹ Net loss was $110.7 million for the quarter, compared to $84.7 million in the same period of 2025.¹