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.
