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XENE Stock Up as Azetukalner Meets Goal in Focal Onset Seizures Study
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Key Takeaways
XENE reported positive phase III X-TOLE2 data for azetukalner in focal onset seizures, stock rises.
XENE's azetukalner (25 mg) dose delivered a -42.7% placebo-adjusted reduction in seizures.
Xenon plans to file an NDA for azetukalner in focal onset seizures in the third quarter of 2026.
Shares of Xenon Pharmaceuticals (XENE - Free Report) 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%.
Image Source: Zacks Investment Research
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.
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%.
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XENE Stock Up as Azetukalner Meets Goal in Focal Onset Seizures Study
Key Takeaways
Shares of Xenon Pharmaceuticals (XENE - Free Report) 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%.
Image Source: Zacks Investment Research
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 - Free Report) , ANI Pharmaceuticals (ANIP - Free Report) and Replimune Group (REPL - Free Report) , 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%.