XENE Stock Up as Azetukalner Meets Goal in Focal Onset Seizures Study

Shares of Xenon Pharmaceuticals XENE surged 49.6% yesterday after the company announced positive top-line data from the phase III X-TOLE2 study, which evaluated its lead pipeline candidate, azetukalner for treating focal onset seizures (FOS).

The X-TOLE2 study evaluated the efficacy, safety and tolerability of 15 mg and 25 mg doses of azetukalner, given with food as an add-on treatment in patients with FOS. The study met its primary endpoint, showing a median percent change (MPC) in monthly FOS frequency from baseline to week 12 for both the 15 mg and 25 mg doses of azetukalner versus placebo.

The placebo-adjusted MPC in the 25 mg group was -42.7%, which was better than the data from the earlier phase IIb X-TOLE study, in which the 25 mg dose showed a placebo-adjusted MPC of -34.6% over eight weeks.

Treatment with azetukalner was generally well-tolerated and demonstrated a safety profile similar to that seen in previous studies.

Xenon plans to submit a new drug application (NDA) to the FDA seeking approval for azetukalner to treat FOS in the third quarter of 2026.

XENE's Price Performance

In the past six months, shares of Xenon have rallied 68.6% compared with the industry’s increase of 14.3%.

XENE's Development Activities With Azetukalner

Under the epilepsy program, the phase III X-TOLE3 study of azetukalner in FOS is currently enrolling patients and is intended to support potential regulatory submissions for azetukalner for FOS in ex-U.S. markets.

Per management, the data from the X-TOLE2 study, along with a favorable safety profile, a differentiated KV7 mechanism, and ease of use, support azetukalner’s potential to become a preferred treatment for patients with uncontrolled seizures. If approved by the FDA, azetukalner would become the only KV7 potassium channel opener available for treating epilepsy.

Besides FOS, azetukalner, a differentiated Kv7 potassium channel, is also being developed for other neurological disorders, including major depressive disorder (MDD) and bipolar depression (BPD). The company is also evaluating azetukalner for primary generalized tonic-clonic seizures in a phase III X-ACKT study, which is currently enrolling patients.

Xenon’s first two of three planned phase III clinical studies, X-NOVA2 and X-NOVA3, evaluating azetukalner in patients with MDD, are currently underway, with top-line data from X-NOVA2 expected in the first half of 2027.

XENE’s first of two phase III clinical studies, X-CEED, evaluating azetukalner in patients with BPD I or II, is also currently ongoing.

Xenon Pharmaceuticals Inc. Price

Xenon Pharmaceuticals Inc. price | Xenon Pharmaceuticals Inc. Quote

XENE's Zacks Rank & Stocks to Consider

Xenon currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are Lexicon Pharmaceuticals LXRX, ANI Pharmaceuticals ANIP and Replimune Group REPL, each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Over the past 60 days, estimates for Lexicon Pharmaceuticals’ 2026 loss per share have narrowed from 27 cents to 19 cents, while the same for 2027 have narrowed from a loss of 22 cents to a loss of 20 cents. LXRX’s shares have rallied 51.4% in the past six months.

Lexicon Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 57.06%.

Over the past 60 days, estimates for ANI Pharmaceuticals’ 2026 earnings per share have increased from $8.20 to $9.00, while the same for 2027 have increased from $9.25 to $10.10. ANIP’s shares have fallen 24.2% in the past six months.

ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.

Over the past 60 days, estimates for Replimune’s 2026 have narrowed from $3.59 to $3.41, while the same for 2027 have narrowed from $2.42 to $2.33. REPL’s shares have rallied 43.6% in the past six months.

Replimune’s earnings beat estimates in one of the trailing four quarters and missed on the remaining three occasions, with the average negative surprise being 4.46%.

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

This article originally published on Zacks Investment Research (zacks.com).

Zacks Investment Research