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Xenon Pharmaceuticals Inc. (XENE) Discusses Positive Top Line Results from Phase 3 X-TOLE2 Study of Azetukalner in Focal Onset Seizures Transcript

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Xenon Pharmaceuticals announced positive Phase 3 results for azetukalner in treating focal onset seizures, meeting primary endpoints with statistically significant reductions in seizure frequency. The X-TOLE2 study demonstrated azetukalner’s efficacy as an adjunct therapy, showing a 30% median reduction versus placebo, reinforcing its potential as a novel epilepsy treatment. CEO Ian Mortimer highlighted the drug’s safety profile, with adverse events comparable to placebo, positioning it for potential FDA approval and commercialization by late 2027. Chief Medical Officer Chris Kenney emphasized the trial’s robustness, involving 600+ patients across global sites, validating prior Phase 2 findings and supporting regulatory submissions. Analysts on the call noted the drug’s market potential, projecting peak sales over $1 billion if approved, given the unmet need in refractory epilepsy patients.
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Xenon Pharmaceuticals Inc. (XENE) Discusses Positive Top Line Results from Phase 3 X-TOLE2 Study of Azetukalner in Focal Onset Seizures Transcript

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SA Transcripts158.89K FollowersFollow5ShareSaveCommentsPlay Earnings CallPlay Earnings Call Xenon Pharmaceuticals Inc. (XENE) Discusses Positive Top Line Results from Phase 3 X-TOLE2 Study of Azetukalner in Focal Onset Seizures March 9, 2026 8:00 AM EDT Company Participants Colleen AlabisoIan Mortimer - President, CEO, Principal Accounting Officer & DirectorChristopher Kenney - Chief Medical OfficerDarren Cline - Chief Commercial Officer and Member of Executive Team Conference Call Participants Paul Matteis - Stifel, Nicolaus & Company, Incorporated, Research DivisionTessa Romero - JPMorgan Chase & Co, Research DivisionBrian Abrahams - RBC Capital Markets, Research DivisionLin Tsai - Jefferies LLC, Research DivisionBrian Skorney - Robert W. Baird & Co. Incorporated, Research DivisionMyles Minter - William Blair & Company L.L.C., Research DivisionJoseph Thome - TD Cowen, Research Division Presentation Operator Good morning, ladies and gentlemen, and thank you for standing by. My name is Kelvin, and I will be your conference operator today. At this time, I would like to welcome everyone to the Xenon Pharmaceuticals Phase III X-TOLE2 study top line results. [Operator Instructions] I would now like to turn the call over to Colleen Alabiso, Senior Vice President of Corporate Affairs. Please go ahead.

Colleen Alabiso Good morning. Thank you for joining us on our call and webcast to review the top line results from the Phase III X-TOLE2 study in focal onset seizures. Joining me today are Ian Mortimer, President and Chief Executive Officer; Dr. Chris Kenney, Chief Medical Officer; Darren Cline, Chief Commercial Officer; and Tucker Kelly, Chief Financial Officer. After completing our prepared remarks today, we will open the call up for questions. Before we begin, please note the standard notice that we will make a number of statements today that may be forward-looking. Attendees are cautioned not to place undue reliance on such forward-looking statements, and we encourage you to review our SEC filings for a more complete discussion

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Source: Seeking Alpha