Xenon Pharmaceuticals (XENE) Company Report

Xenon's lead molecule, azetukalner, a potassium channel modulator, is in development for epilepsy and neuropsychiatry.
The Phase III X-TOLE2 study for focal onset seizures is fully enrolled with 380 subjects and is expected to read out in early 2026. Xenon anticipates filing an NDA in 2026 and potential approval in 2027.
For neuropsychiatry, azetukalner has three Phase III clinical trials ongoing: two in Major Depressive Disorder (X-NOVA2, X-NOVA3) and one in bipolar depression (X-CEED). Data for the first MDD study is anticipated in approximately two to two and a half years from Q1 2025.
Xenon also advanced two pain molecules into Phase I human clinical trials in 2025, including XEN1701 targeting Nav1.7.

Nov 19, 2025, 11:30 AM

Transcript

Xenon Details Upcoming Milestones for Azetukalner and Pain Programs

XENE

Guidance Update

New Projects/Investments

Xenon's lead molecule, azetukalner, is in Phase III development for epilepsy, with the first Phase III readout (XTOL II study) anticipated in early 2026 and an NDA filing expected in 2026. The company is conducting three Phase III epilepsy trials: XTOL II and XTOL III for focal onset seizures, and XACT for primary generalized tonic-clonic seizures.
Azetukalner is also being developed for neuropsychiatry, with three Phase III clinical trials underway: two for Major Depressive Disorder (XNOVA II and XNOVA III) and one for Bipolar Depression (XCEED). The MDD studies are projected to take 2 to 2.5 years to complete, and the bipolar depression study is expected to take longer.
The company's pain portfolio includes two molecules, XEN-1701 (targeting Nav1.7) and a Kv7 target, both of which entered Phase I human clinical trials in 2025. Phase I studies are expected to conclude in 2026, with Phase II proof-of-concept data in patients anticipated in 2027.

Nov 19, 2025, 11:30 AM

Transcript

Xenon Pharmaceuticals Provides Clinical Program Updates and 2026 Outlook

XENE

Guidance Update

New Projects/Investments

Xenon Pharmaceuticals' lead molecule, azetukalner, is in a Phase III XTOL II study for focal onset seizures, which is fully enrolled with 380 subjects and is expected to have data readout in early 2026.
The company is also conducting three Phase III clinical trials for azetukalner in neuropsychiatry: two for major depressive disorder (XNOVA II and XNOVA III) and one for bipolar depression (XCEED). The MDD studies are expected to take 2 to 2.5 years to complete.
Xenon plans to file an NDA in 2026 for epilepsy following the XTOL II readout, with EMA submission likely requiring both XTOL II and XTOL III data.
The pain portfolio has two molecules, XEN-1701 (Nav1.7 target) and a Kv7 target drug, that have moved into Phase I human clinical trials this year, with plans to advance to Phase II proof-of-concept studies next year.
Xenon expects to issue a press release at the beginning of 2026 to provide guidance and outline upcoming milestones.

Nov 19, 2025, 11:30 AM

Transcript

Xenon Pharmaceuticals Provides Update on Clinical Programs and Financial Outlook

XENE

Guidance Update

New Projects/Investments

Product Launch

Xenon Pharmaceuticals expects Phase 3 EXTOL-two data for Azetukalner in epilepsy in early 2026, with an NDA filing planned for next year. The Phase 3 population is similar to the Phase 2b study, which showed best-in-class efficacy.
Azetukalner is also in two ongoing Phase 3 clinical trials for major depressive disorder and a recently initiated Phase 3 trial for bipolar depression, with MDD data estimated to be available in two to two and a half years.
The company's early-stage pain portfolio includes two Phase 1 assets, XCN1701 (NaV1.7) and XCN1120 (Kv7), which are targeted to enter Phase 2 proof of concept studies in 2026.
Xenon aims to move a molecule targeting NaV1.1 for Dravet syndrome into a human clinical trial next year.
Xenon reported over $500 million in cash at the end of the last quarter, providing a cash runway into 2027.

Nov 13, 2025, 8:20 PM

Transcript

Xenon Pharmaceuticals Provides Clinical Program Updates and Financial Outlook

XENE

Guidance Update

New Projects/Investments

Product Launch

Xenon Pharmaceuticals' lead program, Azetukalner, has its Phase 3 EXTOL-two trial for epilepsy fully enrolled, with data expected in early 2026. The company plans to file a New Drug Application (NDA) next year following the phase 3 data.
In psychiatry, Azetukalner is undergoing two Phase 3 clinical trials for Major Depressive Disorder (MDD) and a recently initiated Phase 3 trial for bipolar depression. The MDD Phase 3 data is estimated to take two to two and a half years to run.
The company's early-stage pain portfolio includes two Phase 1 assets, XCN1701 (NaV1.7) and XCN1120 (Kv7), which are anticipated to enter Phase 2 proof-of-concept studies in 2026.
Xenon Pharmaceuticals reported over $500 million in cash at the end of the last quarter, providing a cash runway into 2027.

Nov 13, 2025, 8:20 PM

Transcript

Xenon Pharmaceuticals Provides Update on Clinical Pipeline and Financial Outlook

XENE

New Projects/Investments

Guidance Update

Xenon Pharmaceuticals anticipates Phase III data for azetukalner in epilepsy (X-TOLE2) in early 2026, with an NDA filing expected in 2026.
The company is progressing azetukalner in psychiatry with two ongoing Phase III studies for major depressive disorder and a recently initiated Phase III trial for bipolar depression.
Two early-stage pain assets, XEN 1701 (NaV1.7) and XEN 1120 (Kv7), are in Phase I studies and are expected to enter Phase II proof-of-concept studies in 2026.
Xenon reported over $500 million in cash at the end of the last quarter, providing a cash runway into 2027.

Nov 13, 2025, 8:20 PM

Transcript

Xenon Pharmaceuticals reports Q3 2025 results, completes X-TOLE2 randomization, and updates on pipeline progress

XENE

Earnings

CFO Change

New Projects/Investments

Xenon Pharmaceuticals (XENE) completed randomization for its Phase III X-TOLE2 study of azetukalner for focal onset seizures with 380 patients, exceeding the target of 360, and anticipates top-line data readout in early 2026.
The company reported cash, cash equivalents, and marketable securities of $555.3 million as of September 30, 2025, and expects this to fund operations into 2027.
Tucker Kelly joined as Chief Financial Officer.
Xenon is also progressing azetukalner in neuropsychiatric indications, with Phase III X-NOVA2 and X-NOVA3 studies for major depressive disorder and the X-ACKT study for bipolar I and II depression currently enrolling patients. Additionally, early-stage Nav1.7 and Kv7 modulators (XEN1701 and XEN1120) have entered Phase I studies.

Nov 3, 2025, 9:30 PM

Transcript

Xenon Pharmaceuticals Announces Q3 2025 Results, XTOL-2 Study Progress, and New CFO

XENE

Earnings

CFO Change

Guidance Update

Xenon Pharmaceuticals reported cash, cash equivalents, and marketable securities totaling $555.3 million as of September 30, 2025, and anticipates having sufficient cash to fund operations into 2027.
The company announced that all 380 patients have been randomized in the Phase 3 XTOL-2 study of Ezetikelner for focal onset seizures, exceeding the original goal of 360 patients, with top-line data expected in early 2026.
Xenon is expanding Ezetikelner's therapeutic opportunities into neuropsychiatric indications and advancing earlier-stage programs, including Nav1.7 and KV7 modulators in Phase 1 studies, and a Nav1.1 candidate expected to enter IND-enabling studies later this year.
Tucker Kelly was appointed as the new Chief Financial Officer.

Nov 3, 2025, 9:30 PM

Transcript

Xenon Pharmaceuticals Provides Q3 2025 Financial and Clinical Updates

XENE

Earnings

Guidance Update

New Projects/Investments

Xenon Pharmaceuticals reported $555.3 million in cash, cash equivalents, and marketable securities as of September 30, 2025, and anticipates this will fund operations into 2027.
The Phase 3 XTOL-2 study of Ezetikelner for focal onset seizures has completed randomization with 380 patients, exceeding its target, and remains on track for top-line data readout in early 2026.
Ezetikelner's clinical development is expanding into neuropsychiatric indications, with Phase 3 XNova-2 and XNova-3 studies for Major Depressive Disorder and the XCEED study for Bipolar I and II Depression currently underway and enrolling patients.
Early-stage programs, XEN1701 and XEN1120, are progressing in Phase 1 studies for pain, with results anticipated in the first part of 2026.

Nov 3, 2025, 9:30 PM

Transcript

Xenon Pharmaceuticals Inc. Reports Q3 2025 Financial Results and Business Update

XENE

Earnings

CFO Change

New Projects/Investments

Xenon Pharmaceuticals Inc. reported a net loss of $90.9 million for the third quarter ended September 30, 2025, compared to $62.8 million for the same period in 2024, primarily due to increased research and development expenses.
As of September 30, 2025, cash, cash equivalents, and marketable securities totaled $555.3 million, down from $754.4 million as of December 31, 2024, with the company anticipating sufficient cash to fund operations into 2027.
The Phase 3 X-TOLE2 study of azetukalner in focal onset seizures has completed patient randomization, with topline data anticipated in early 2026.
Tucker Kelly was appointed as Chief Financial Officer.

Nov 3, 2025, 9:04 PM

8-K

Earnings Transcripts

Quarterly earnings call transcripts for Xenon Pharmaceuticals.

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