8-K - Xenon Pharmaceuticals Inc. | StockGist

AI Analysis

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Xenon Pharmaceuticals Inc. announced positive topline data from the Phase 3 X-TOLE2 study of azetukalner in focal onset seizures, meeting primary endpoint with -53.2% median percent change in monthly FOS frequency for 25 mg dose (p=0.000000000006) versus -10.4% for placebo, and plans NDA submission to FDA in Q3 2026.

Key Takeaways

1X-TOLE2 met primary endpoint: -53.2% MPC (25 mg), -34.5% MPC (15 mg), -10.4% placebo (p<0.0001)

2Placebo-adjusted MPC -42.7% (25 mg) outperformed Phase 2b X-TOLE (-34.6%)

3RR50: 54.8% (25 mg), 37.6% (15 mg), 20.8% placebo (p<0.01)

4Safety profile consistent with X-TOLE; dizziness 20.5% (azetukalner) vs 3.2% placebo

5NDA submission to FDA planned Q3 2026 for FOS

6380 participants randomized; median 5 prior ASMs, baseline 12.75 FOS/month

Current Report Details

Event Type

Regulation Fd

Exhibits Only

Disclosure

Voluntary

Variant

8-K

Items Reported

7.01

(including Exhibits 99.1 and 99.2 attached hereto) is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act

Regulation Fd

9.01

Financial Statements and Exhibits. (d) Exhibits Exhibit No. Description 99.1 Press Release issued by Xenon Pharmaceuticals Inc. dated March 9, 2026 99.2 Investo

Exhibits Only

Source Document

Exhibits (3)

8-K

99.1

EX-99.1

99.2

EX-99.2