Xenon reports positive Phase 3 X-TOLE2 data for azetukalner; NDA submission planned Q3 2026

Xenon Pharmaceuticals Inc.

2026-Q1 EPS reported -$1.17

Phase 3 X-TOLE2 met primary endpoint: median percent change in monthly FOS -53.2% (25mg) and -34.5% (15mg) vs -10.4% placebo (p<0.0001).
NDA submission to FDA planned Q3 2026 based on X-TOLE2 and X-TOLE data.
Cash and marketable securities $1.34B as of March 31; cash runway into 2029. Net loss $102.3M for Q1 2026.
Enrollment ongoing for additional Phase 3 studies: X-TOLE3 (FOS), X-ACKT (PGTCS), X-NOVA2/3 (MDD), X-CEED (BPD); X-NOVA2 topline H1 2027.

item 2.02 item 7.01 item 9.01

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Earnings Releases SEC 8-K Item 2.02 confidence 0.9

Xenon Pharmaceuticals Inc. reported financial results for the three months ended March 31, 2026.

Period: the three months ended March 31, 2026
Result: reported results

Exact text from the filing

On May 7, 2026, Xenon Pharmaceuticals Inc. (the “Company”) announced via press release the Company’s financial results for the three months ended March 31, 2026.

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8 earnings releases filed in the last 30 days. Browse all earnings releases →

Xenon Pharmaceuticals Inc. filing history →

Source: SEC EDGAR

accession 0001193125-26-211843

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