By Siddhi Mahatole
March 9 (Reuters) – Xenon Pharmaceuticals said on Monday its experimental epilepsy drug met the main goal of showing a statistically significant reduction in focal onset seizures in a late-stage trial, sending its shares up 45% in morning trade.
In the trial, patients treated with the drug, azetukalner, showed a median reduction in monthly seizure frequency of 53.2% at the 25 mg dose and 34.5% at the 15 mg dose, compared with 10.4% for placebo over 12 weeks.
The placebo-adjusted reduction for the 25 mg dose was 42.7%, which the drug developer said exceeded results seen in earlier studies.
“Investors were debating if the bar should be 25% or 30% on a placebo-normalized basis and the data clearly blasts through both,” said William Blair analyst Myles Minter.
Focal onset seizure is a form of epilepsy in which the abnormal activity originates in one area of the brain.
The company’s shares were last trading at an all-time high of $62.64.
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The results support the drug’s clear differentiation from currently available anti-seizure medicines, analysts said.
More than half of those given the 25 mg dose saw their seizure frequency cut by at least half, compared with 20.8% of patients on placebo.
“Azetukalner seizes the spotlight,” said J.P. Morgan analyst Tessa T Romero, particularly highlighting its efficacy in a highly treatment-resistant population.
At least two analysts said they expect more than $2 billion in peak sales for the drug.
The company expects to file for approval in the third quarter, with a decision by the Food and Drug Administration likely in late 2027 or early 2028.
On a call with analysts, Chief Commercial Officer Darren Cline said the company believes azetukalner’s data and novel mechanism “demands” optimized pricing.
The company said it plans to keep all four labeled doses – 10 mg, 15 mg, 20 mg and 25 mg – at “flat pricing” so physicians can start patients at any level and escalate treatment without cost differences.
(Reporting by Siddhi Mahatole in Bengaluru; Editing by Janane Venkatraman, Sriraj Kalluvila and Maju Samuel)
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