Xenon Pharmaceuticals stock price soars 40% on positive trial data

LootboxPhobia · 2026-03-09T19:38:46+00:00

Xenon Pharmaceuticals' stock price rose 40% due to azetukalner's positive results in a Phase 3 study for focal seizures. The 25 mg dose group experienced a 53.2% reduction in seizure frequency from baseline. The drug has a good safety profile and is planned to submit a New Drug Application in 2026. If approved, it will fill a market gap for KV7 potassium channel openers in epilepsy treatment.

LootboxPhobia

2026-03-09 19:38:46

Abstract generation in progress

Investing.com – Xenon Pharmaceuticals Inc. (NASDAQ:XENE) stock rose 40% on Monday after the company announced positive topline results from the Phase 3 X-TOLE2 study of azetukalner for the treatment of focal seizures.

The study met its primary endpoints in both dose groups, with the 25 mg dose group showing a median percentage change from baseline of -53.2% in monthly focal seizure frequency, compared to -10.4% in the placebo group. The median percentage change adjusted for placebo in the 25 mg group was -42.7%, outperforming the company’s Phase 2b X-TOLE study, where the 25 mg dose group had a placebo-adjusted median percentage change of -34.6%.

The study also achieved its key secondary endpoint—the 50% responder rate—with 54.8% of participants in the 25 mg group and 37.6% in the 15 mg group experiencing at least a 50% reduction in monthly focal seizure frequency from baseline, compared to 20.8% in the placebo group.

A total of 380 participants with highly refractory epilepsy were enrolled, with a median of 5 antiepileptic drugs previously used and a baseline seizure frequency of 12.75 per month. Of the 332 participants who completed the double-blind phase, 322 entered an open-label extension study.

Azetukalner was generally well tolerated, with safety profiles consistent with those observed in the X-TOLE study. The most common treatment-related adverse events in both azetukalner dose groups were dizziness, headache, somnolence, and fatigue.

Xenon plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in Q3 2026 for the treatment of focal seizures. If approved, azetukalner will become the only KV7 potassium channel opener indicated for epilepsy treatment.

Stifel analyst comments, “We believe these results could prompt investors to reconsider their assumptions about peak penetration and peak sales.”

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