Xenon Completes Enrollment of 380 Patients in Phase 3 Azetukalner Study
Phase 3 Azetukalner Program in Epilepsy & Depression: Phase 3 X-TOLE2 study of azetukalner in focal onset seizures has completed enrollment with 380 patients randomized, and final data are being collected to support the topline data readout anticipated in March 2026. Patient baseline characteristics and the open-label extension rollover rate in X-TOLE2 are consistent with the Phase 2b X-TOLE study. Xenon recently presented 48-month data from the ongoing X-TOLE OLE study of azetukalner in patients with FOS at the American Epilepsy Society meeting. These data highlighted the long-term efficacy and safety of azetukalner, with reductions in monthly FOS frequency of over 90% from double-blind period baseline among participants treated greater than or equal to48 months. Seizure freedom for any greater than or equal to12, greater than or equal to24, greater than or equal to36, and greater than or equal to48-month consecutive duration was attained by 38.2%, 25.2%, 19.8%, and 10.7% of participants treated for greater than or equal to48 months, respectively. These data, along with an update on Xenon's progress preparing for potential commercialization of azetukalner, were also highlighted in a webinar for investors in December 2025. Phase 3 X-TOLE3 study of azetukalner in FOS continues to enroll and is intended to support regulatory submissions outside the United States. In support of a potential regulatory submission in Japan, Xenon has completed an ethnobridging study and shared the results in a recent meeting with Japan's Pharmaceutical and Medical Devices Agency. Xenon has aligned with PMDA to enroll approximately 60 of the planned 360 X-TOLE3 participants in Japan. Enrollment of non-Japanese participants in X-TOLE3 is expected to complete in 2026. Phase 3 X-ACKT study of azetukalner in Primary Generalized Tonic-Clonic Seizures continues to enroll and is intended to support regulatory submissions for an additional epilepsy indication. Phase 3 X-NOVA2 and X-NOVA3 studies are ongoing as the first two of three planned Phase 3 clinical studies evaluating azetukalner in patients with major depressive disorder. Topline data from X-NOVA2 are expected in H1 2027. Phase 3 X-CEED study evaluating azetukalner in patients with bipolar depression I or II is underway. Broader Pipeline Opportunity: Phase 1 Single Ascending Dose/Multiple Ascending Dose study in healthy adult participants is underway for XEN1701 targeting the sodium channel NaV1.7. Preliminary Phase 1 data from the SAD portion of the study suggest that XEN1701 has reached drug concentrations that are predicted to achieve receptor occupancies required for therapeutic activity based on human genetic data. Study completion is expected in 2026 to support initiating a Phase 2 proof-of-concept study in acute pain. NaV1.7 is an important target for pain based on strong human genetic validation and may represent a new class of pain medicines without the limitations of opioids. Phase 1 SAD/MAD study in healthy adult participants is underway for XEN1120 targeting KV7. Preliminary Phase 1 data from the SAD portion of the study suggest that XEN1120 has reached drug concentrations that are consistent with pain reductions in preclinical models. Study completion is expected in 2026 to support initiating a Phase 2 proof-of-concept study in acute pain. IND-enabling studies are ongoing for the Company's NaV1.1 program for the treatment of Dravet syndrome. Pre-clinical data suggest that targeting NaV1.1 could potentially address the underlying cause and symptoms of Dravet syndrome. In collaboration with Neurocrine Biosciences, a Phase 1 study is ongoing for NBI-921355, an investigational, selective inhibitor of voltage-gated sodium channels NaV1.2 and NaV1.6 in development for the potential treatment of certain types of epilepsy.
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Xenon Pharmaceuticals Grants 42,300 Stock Options to New Employees
- Employee Incentive Program: Xenon Pharmaceuticals grants 42,300 stock options to ten new employees to attract talent and enhance employee loyalty, in compliance with Nasdaq Listing Rule 5635(c)(4).
- Option Exercise Price: The options have an exercise price of $40.74 per share, equal to the closing price on January 15, 2026, ensuring employees can benefit financially as the company performs well.
- Vesting Schedule: The granted options will vest over four years, with 25% vesting after the first year and the remainder vesting monthly, aimed at incentivizing long-term employee retention and driving company growth.
- Clinical Development Progress: Xenon's lead molecule, azetukalner, is in Phase 3 trials for epilepsy and major depressive disorder, and the incentive plan will help attract more talent to support its research and development efforts.
Biohaven's BHV-7000 Fails Phase 2 Depression Trial, Shares Drop 15.45%
- Clinical Trial Outcome: Biohaven Ltd.'s BHV-7000 failed to meet its primary endpoint in a Phase 2 trial for major depressive disorder, although favorable trends were noted in some severely depressed subgroups, which may impact future R&D directions.
- Safety Assessment: While BHV-7000 was mostly safe with mild to moderate adverse events largely resolving spontaneously, the lack of significant efficacy signals raises investor concerns about its market prospects.
- Resource Reallocation: The company has decided against further psychiatric clinical trials, opting instead to focus resources on key priority areas such as immunology, obesity, and epilepsy, indicating a strategic shift in focus.
- Market Reaction: Biohaven's shares fell 15.45% to $9.14 in premarket trading on Friday, reflecting negative market sentiment regarding the trial results, with analysts remaining cautious about future regulatory clarity and data outcomes.
Significant Monday Options Trading: MDB, XENE, SNOW
Xenon Pharmaceuticals Options Activity: Xenon Pharmaceuticals Inc (XENE) has seen a trading volume of 6,057 options contracts today, equating to about 605,700 underlying shares, which is 79.2% of its average daily trading volume over the past month.
High Volume Put Option for XENE: The $30 strike put option expiring on April 17, 2026, has particularly high activity, with 2,000 contracts traded, representing approximately 200,000 underlying shares.
Snowflake Inc Options Activity: Snowflake Inc (SNOW) has recorded a trading volume of 42,519 options contracts today, amounting to around 4.3 million underlying shares, or 76.1% of its average daily trading volume over the past month.
High Volume Call Option for SNOW: The $250 strike call option expiring on December 12, 2025, has notable trading activity, with 2,265 contracts traded, representing about 226,500 underlying shares.
Xenon Pharmaceuticals Reports 90.9% Monthly Seizure Frequency Reduction in Long-Term Azetukalner Study
- Significant Efficacy: In the X-TOLE OLE study, participants treated for ≥48 months experienced a 90.9% reduction in monthly seizure frequency, demonstrating azetukalner's exceptional efficacy in long-term use, potentially offering new hope for patients with difficult-to-treat epilepsy.
- Sustained Freedom Periods: Among participants treated for ≥48 months, 38.2% achieved seizure freedom for ≥12 months, indicating that azetukalner not only helps patients attain seizure freedom but also enables them to regain extended periods of freedom after breakthrough seizures, enhancing its clinical applicability.
- Good Safety Profile: The long-term safety of azetukalner was comparable to that observed during the double-blind period, ensuring patient safety and tolerability during treatment, which further solidifies its market position as an anti-seizure medication.
- Broad Research: Xenon presented multiple studies at the American Epilepsy Society Annual Meeting, highlighting the impact of depression on epilepsy patients, underscoring the importance of addressing mental health in this population, which may drive adjustments in future clinical treatment strategies.
Xenon Reports 90.9% Seizure Frequency Reduction in Long-Term Epilepsy Study
- Significant Efficacy: In the X-TOLE open-label extension study, patients treated for ≥48 months experienced a remarkable 90.9% monthly reduction in seizure frequency, demonstrating the long-term efficacy of azetukalner and its potential to reshape epilepsy treatment paradigms.
- Sustained Freedom: Among participants treated for ≥48 months, 38.2% achieved seizure freedom for ≥12 months, indicating the drug's potential in difficult-to-treat epilepsy patients and providing crucial insights for future clinical practice.
- Mental Health Impact: Research revealed that 80.6% of epilepsy patients reported depressive symptoms, underscoring the need for routine depression screening in clinical practice to enhance overall patient quality of life.
- New Drug Development: Early-stage research on Dravet syndrome indicates that XPC-837 may improve motor function, signaling further innovation and development in the epilepsy treatment landscape.
Xenon Pharmaceuticals Grants 39,250 Stock Options to New Employees
- Employee Incentive Program: On December 4, 2025, Xenon Pharmaceuticals granted 39,250 stock options to five new non-officer employees, aimed at attracting and retaining talent, thereby enhancing the company's competitiveness in the biopharmaceutical sector.
- Option Details: The options have an exercise price of $44.61 per share, equal to the closing price on the grant date, vesting over four years with 25% vesting after the first year and the remainder vesting monthly, ensuring long-term employee commitment.
- Strategic Implications: By implementing this incentive program, Xenon not only boosts employee loyalty but also attracts top talent in the rapidly evolving neuroscience field, facilitating future innovation and growth.
- Clinical Development Progress: Xenon's lead molecule, azetukalner, is currently in Phase 3 clinical trials for treating epilepsy and major depressive disorder, and the option grants will help attract key personnel to accelerate the R&D process.
Xenon Pharmaceuticals Grants 42,300 Stock Options to New Employees
- Employee Incentive Program: Xenon Pharmaceuticals grants 42,300 stock options to ten new employees to attract talent and enhance employee loyalty, in compliance with Nasdaq Listing Rule 5635(c)(4).
- Option Exercise Price: The options have an exercise price of $40.74 per share, equal to the closing price on January 15, 2026, ensuring employees can benefit financially as the company performs well.
- Vesting Schedule: The granted options will vest over four years, with 25% vesting after the first year and the remainder vesting monthly, aimed at incentivizing long-term employee retention and driving company growth.
- Clinical Development Progress: Xenon's lead molecule, azetukalner, is in Phase 3 trials for epilepsy and major depressive disorder, and the incentive plan will help attract more talent to support its research and development efforts.
Biohaven's BHV-7000 Fails Phase 2 Depression Trial, Shares Drop 15.45%
- Clinical Trial Outcome: Biohaven Ltd.'s BHV-7000 failed to meet its primary endpoint in a Phase 2 trial for major depressive disorder, although favorable trends were noted in some severely depressed subgroups, which may impact future R&D directions.
- Safety Assessment: While BHV-7000 was mostly safe with mild to moderate adverse events largely resolving spontaneously, the lack of significant efficacy signals raises investor concerns about its market prospects.
- Resource Reallocation: The company has decided against further psychiatric clinical trials, opting instead to focus resources on key priority areas such as immunology, obesity, and epilepsy, indicating a strategic shift in focus.
- Market Reaction: Biohaven's shares fell 15.45% to $9.14 in premarket trading on Friday, reflecting negative market sentiment regarding the trial results, with analysts remaining cautious about future regulatory clarity and data outcomes.
Significant Monday Options Trading: MDB, XENE, SNOW
Xenon Pharmaceuticals Options Activity: Xenon Pharmaceuticals Inc (XENE) has seen a trading volume of 6,057 options contracts today, equating to about 605,700 underlying shares, which is 79.2% of its average daily trading volume over the past month.
High Volume Put Option for XENE: The $30 strike put option expiring on April 17, 2026, has particularly high activity, with 2,000 contracts traded, representing approximately 200,000 underlying shares.
Snowflake Inc Options Activity: Snowflake Inc (SNOW) has recorded a trading volume of 42,519 options contracts today, amounting to around 4.3 million underlying shares, or 76.1% of its average daily trading volume over the past month.
High Volume Call Option for SNOW: The $250 strike call option expiring on December 12, 2025, has notable trading activity, with 2,265 contracts traded, representing about 226,500 underlying shares.
Xenon Pharmaceuticals Reports 90.9% Monthly Seizure Frequency Reduction in Long-Term Azetukalner Study
- Significant Efficacy: In the X-TOLE OLE study, participants treated for ≥48 months experienced a 90.9% reduction in monthly seizure frequency, demonstrating azetukalner's exceptional efficacy in long-term use, potentially offering new hope for patients with difficult-to-treat epilepsy.
- Sustained Freedom Periods: Among participants treated for ≥48 months, 38.2% achieved seizure freedom for ≥12 months, indicating that azetukalner not only helps patients attain seizure freedom but also enables them to regain extended periods of freedom after breakthrough seizures, enhancing its clinical applicability.
- Good Safety Profile: The long-term safety of azetukalner was comparable to that observed during the double-blind period, ensuring patient safety and tolerability during treatment, which further solidifies its market position as an anti-seizure medication.
- Broad Research: Xenon presented multiple studies at the American Epilepsy Society Annual Meeting, highlighting the impact of depression on epilepsy patients, underscoring the importance of addressing mental health in this population, which may drive adjustments in future clinical treatment strategies.
Xenon Reports 90.9% Seizure Frequency Reduction in Long-Term Epilepsy Study
- Significant Efficacy: In the X-TOLE open-label extension study, patients treated for ≥48 months experienced a remarkable 90.9% monthly reduction in seizure frequency, demonstrating the long-term efficacy of azetukalner and its potential to reshape epilepsy treatment paradigms.
- Sustained Freedom: Among participants treated for ≥48 months, 38.2% achieved seizure freedom for ≥12 months, indicating the drug's potential in difficult-to-treat epilepsy patients and providing crucial insights for future clinical practice.
- Mental Health Impact: Research revealed that 80.6% of epilepsy patients reported depressive symptoms, underscoring the need for routine depression screening in clinical practice to enhance overall patient quality of life.
- New Drug Development: Early-stage research on Dravet syndrome indicates that XPC-837 may improve motor function, signaling further innovation and development in the epilepsy treatment landscape.
Xenon Pharmaceuticals Grants 39,250 Stock Options to New Employees
- Employee Incentive Program: On December 4, 2025, Xenon Pharmaceuticals granted 39,250 stock options to five new non-officer employees, aimed at attracting and retaining talent, thereby enhancing the company's competitiveness in the biopharmaceutical sector.
- Option Details: The options have an exercise price of $44.61 per share, equal to the closing price on the grant date, vesting over four years with 25% vesting after the first year and the remainder vesting monthly, ensuring long-term employee commitment.
- Strategic Implications: By implementing this incentive program, Xenon not only boosts employee loyalty but also attracts top talent in the rapidly evolving neuroscience field, facilitating future innovation and growth.
- Clinical Development Progress: Xenon's lead molecule, azetukalner, is currently in Phase 3 clinical trials for treating epilepsy and major depressive disorder, and the option grants will help attract key personnel to accelerate the R&D process.
