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Xenon to Present New Azetukalner OLE Study Data in Epilepsy at AES 2025
Globenewswire· 2025-11-25 13:30
Core Insights - Xenon Pharmaceuticals Inc. is set to present multiple research findings at the American Epilepsy Society Annual Meeting (AES 2025) from December 5-9, 2025, focusing on their lead molecule azetukalner for epilepsy treatment [1][5][9] - The presentations will include long-term data from the X-TOLE open-label extension study, which supports the potential for extended seizure freedom with azetukalner [1][5][6] - Additional findings will address the impact of depression on epilepsy patients and new pre-clinical data from the NaV1.1 program targeting Dravet syndrome [1][5][9] Presentation Details - Seven posters will be presented, including: - Long-term safety and efficacy data of azetukalner in adults with focal epilepsy, with a ≥48-month interim analysis from the ongoing 7-year X-TOLE study [6] - Characterization of long-term seizure freedom in the ongoing open-label extension of X-TOLE [6] - Studies on depression symptoms among epilepsy patients and their impact on treatment outcomes [6][5] - A symposium titled "Exploring Depression and Anxiety in Epilepsy" will be held in partnership with the Epilepsy Foundation of America [5] Company Overview - Xenon Pharmaceuticals is a neuroscience-focused biopharmaceutical company dedicated to drug discovery and development of therapeutics for epilepsy and other neurological disorders [9] - The company's lead molecule, azetukalner, is a selective KV7 potassium channel opener currently in Phase 3 clinical trials for epilepsy, major depressive disorder, and bipolar depression [9] - Xenon is also advancing early-stage programs targeting potassium and sodium channels for potential pain treatment [9]
Xenon Pharmaceuticals (NasdaqGM:XENE) 2025 Conference Transcript
2025-11-19 12:32
Xenon Pharmaceuticals (NasdaqGM:XENE) 2025 Conference November 19, 2025 06:30 AM ET Company ParticipantsIan Mortimer - CEOConference Call ParticipantsAndrew Tsai - Senior Biotech AnalystAndrew TsaiAll right, we're going to get started with our next session. I'm Andrew Tsai, Senior Biotech Analyst at Jefferies. Thanks for tuning in. It's my pleasure to have Ian Mortimer, CEO of Xenon. Welcome, Ian.Ian MortimerThanks, Andrew. Thanks for having us. Thanks to you for hosting.Andrew TsaiOf course. Exciting time ...
Xenon Reports Third Quarter 2025 Financial Results & Business Update
Globenewswire· 2025-11-03 21:01
Core Insights - Xenon Pharmaceuticals is entering a significant period with multiple clinical catalysts, including the completion of patient randomization in the Phase 3 X-TOLE2 study of azetukalner, with topline data expected in early 2026 [1][2] - The company has appointed Tucker Kelly as Chief Financial Officer to enhance its strategic finance capabilities ahead of the azetukalner launch [1][9] - Financial results for Q3 2025 show a net loss of $90.9 million, an increase from $62.8 million in Q3 2024, primarily due to higher research and development expenses [13][23] Clinical Development - The Phase 3 X-TOLE2 study of azetukalner in focal onset seizures (FOS) has completed patient enrollment with 380 patients randomized, and topline data is anticipated in early 2026 [7][14] - Ongoing Phase 3 studies include X-NOVA2 and X-NOVA3 for major depressive disorder (MDD) and X-CEED for bipolar depression (BPD), with recruitment continuing [6][16] - Azetukalner is a selective Kv7 potassium channel opener, currently in late-stage clinical development for epilepsy and neuropsychiatric disorders [3][17] Financial Overview - As of September 30, 2025, the company reported cash, cash equivalents, and marketable securities totaling $555.3 million, down from $754.4 million at the end of 2024 [13] - Research and development expenses for Q3 2025 were $77.1 million, compared to $57.0 million in Q3 2024, reflecting increased costs associated with ongoing clinical studies [13][23] - General and administrative expenses rose to $19.3 million in Q3 2025 from $16.7 million in Q3 2024, primarily due to higher professional and consulting fees [13][23] Pipeline and Future Plans - The company is advancing its early-stage pipeline, including two first-in-human Phase 1 studies for lead molecules targeting Nav1.7 and Kv7 for pain management [5][12] - A Phase 1 study for NBI-921355, a sodium channel inhibitor in collaboration with Neurocrine Biosciences, is also underway [8] - Xenon plans to present new long-term safety and efficacy data at the upcoming American Epilepsy Society meeting in December 2025 [7]
Xenon to Report Q3 2025 Financial Results on November 3, 2025
Globenewswire· 2025-10-27 12:30
Company Overview - Xenon Pharmaceuticals Inc. is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of therapeutics for patients in need [3] - The company is advancing its lead molecule, azetukalner, which is a selective Kv7 potassium channel opener currently in Phase 3 clinical trials for epilepsy, major depressive disorder (MDD), and bipolar depression (BPD) [3] - Additionally, Xenon is developing an early-stage portfolio of potassium and sodium channel modulators, including Kv7 and Nav1.7 programs in Phase 1 development for pain treatment [3] Upcoming Financial Results - Xenon Pharmaceuticals will report its third quarter 2025 financial results and provide a business update after the close of U.S. financial markets on November 3, 2025 [1] - A conference call and webcast will take place on the same day at 4:30 pm Eastern Time (1:30 pm Pacific Time) [2] Contact Information - Colleen Alabiso is the Senior Vice President of Corporate Affairs, and can be reached at (617) 671-9238 [5] - Media inquiries can be directed to media@xenon-pharma.com, while investor inquiries can be sent to investors@xenon-pharma.com [5]
Xenon Announces Appointment of Tucker Kelly as Chief Financial Officer
Globenewswire· 2025-10-16 12:30
Core Insights - Xenon Pharmaceuticals Inc. has appointed Tucker Kelly as Chief Financial Officer, bringing extensive strategic and commercial finance expertise to the company as it prepares for the commercialization of its lead candidate, azetukalner [1][2] Company Overview - Xenon Pharmaceuticals is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of therapeutics for patients in need [4] - The company is advancing azetukalner, a selective Kv7 potassium channel opener, currently in Phase 3 clinical trials for epilepsy, major depressive disorder, and bipolar depression [5] Leadership Appointment - Tucker Kelly has over 25 years of experience in corporate and financial strategy for life sciences companies, previously serving as Executive Vice President, CFO, and Treasurer at Deciphera Pharmaceuticals [2] - His role at Deciphera included overseeing the company's growth and strategic financial planning, culminating in a $2.4 billion acquisition by Ono Pharmaceuticals in 2024 [2] Compensation Details - In connection with his appointment, Mr. Kelly was granted an option to purchase 225,000 common shares at an exercise price of $41.90, with shares vesting over four years [3] - Additionally, he received 30,000 restricted share units (RSUs) that will vest over four years, subject to his continued service with the company [3]
Xenon Announces Upcoming Investor Webinar to Discuss Early-Stage Ion Channel Programs for the Potential Treatment of Pain
Globenewswire· 2025-09-25 20:01
Core Insights - Xenon Pharmaceuticals Inc. is hosting an investor webinar on October 6, 2025, to discuss its early-stage programs targeting Kv7 and Nav1.7 as potential non-opioid treatments for pain [1][2]. Company Overview - Xenon Pharmaceuticals is a neuroscience-focused biopharmaceutical company engaged in drug discovery, clinical development, and commercialization of therapeutics for patients in need [4]. - The company's lead molecule, azetukalner, is a selective Kv7 potassium channel opener currently in Phase 3 clinical trials for epilepsy, major depressive disorder (MDD), and bipolar depression (BPD) [4]. - Xenon is also advancing a portfolio of potassium and sodium channel modulators, including Kv7 and Nav1.7 programs in Phase 1 development for pain treatment [4]. Webinar Details - The webinar will take place from 11:30 AM to 12:30 PM Eastern Time, and participants can submit questions via chat or email [2]. - A live webcast will be available on the "Investors" section of Xenon's website, with a replay posted after the event [3].
Why Is Xenon Pharmaceuticals (XENE) Up 4.2% Since Last Earnings Report?
ZACKS· 2025-09-10 16:30
Company Overview - Xenon Pharmaceuticals reported a loss of $1.07 per share for Q2 2025, which was wider than the Zacks Consensus Estimate of a loss of $1.03, compared to a loss of $0.75 per share in the same quarter last year [3] - The company did not generate any revenues in the reported quarter, similar to the year-ago quarter, due to the absence of a marketed product [4] Financial Performance - Research and development (R&D) expenses increased by 51% year over year to $75 million, driven by costs related to ongoing studies and a larger workforce [5] - General and administrative expenses were $19.2 million, remaining relatively flat year over year [5] - As of June 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $624.8 million, down from $691.1 million as of March 31, 2025 [6] Market Sentiment - There has been a downward trend in estimates revision for Xenon Pharmaceuticals over the past month [7] - The company has a poor Growth Score of F and a Momentum Score of D, resulting in an aggregate VGM Score of F [8] Industry Context - Xenon Pharmaceuticals is part of the Zacks Medical - Biomedical and Genetics industry, where Intellia Therapeutics, a peer, gained 9.4% over the past month [10] - Intellia Therapeutics reported revenues of $14.24 million for the last quarter, reflecting a year-over-year change of +104.6% [11]
Xenon Pharmaceuticals: Pushing Azetukalner Towards Finish Line With Phase 3 2026 Data Release
Seeking Alpha· 2025-08-12 18:48
Group 1 - Xenon (NASDAQ: XENE) is nearing completion of its phase 3 X-TOLE2 trial for its Kv7 potassium channel opener azetukalner, aimed at treating patients with focal onset seizures (FOS) [2] - The Biotech Analysis Central service offers a comprehensive analysis of over 600 biotech investing articles and a model portfolio of more than 10 small and mid-cap stocks [2] - The service is available for $49 per month, with a yearly plan offering a 33.50% discount, bringing the price to $399 per year [1]
Xenon Q2 Loss Wider Than Expected, Pipeline Development in Focus
ZACKS· 2025-08-12 15:21
Core Insights - Xenon Pharmaceuticals (XENE) reported a loss of $1.07 per share for Q2 2025, which is wider than the Zacks Consensus Estimate of a loss of $1.03 and a loss of 75 cents per share in the same quarter last year [1][6] - The company did not generate any revenues in the reported quarter, consistent with the year-ago quarter, due to the absence of a marketed product [2][6] Financial Performance - Research and development (R&D) expenses increased by 51% year over year to $75 million, driven by costs related to ongoing studies for azetukalner in epilepsy and major depressive disorder (MDD), as well as higher personnel expenses [4][6] - General and administrative expenses were $19.2 million, remaining relatively flat year over year [5] - Cash reserves decreased from $691.1 million as of March 31, 2025, to $624.8 million as of June 30, 2025, which is expected to fund operations into 2027 [7] Pipeline Developments - Xenon's lead drug, azetukalner, is in late-stage studies for focal onset seizures (FOS) with two phase III studies, X-TOLE2 and X-TOLE3, evaluating different doses [8] - The first top-line data readout from the X-TOLE2 study is anticipated in early 2026, while the X-TOLE3 study is currently enrolling patients [8] - Azetukalner is also being evaluated in a phase III study for primary generalized tonic-clonic seizures and in two phase III studies for MDD [9][10] Collaboration and Milestones - In collaboration with Neurocrine Biosciences, Xenon is evaluating NBI-921355, a Nav1.2/1.6 inhibitor, in a phase I study for epilepsy [3] - Xenon received a $7.5 million milestone payment from Neurocrine related to the progress of NBI-921355 into clinical-stage studies [3]
Xenon Reports Second Quarter 2025 Financial Results & Business Update
GlobeNewswire News Room· 2025-08-11 20:01
Core Insights - Completion of patient recruitment for Phase 3 X-TOLE2 study of azetukalner marks a significant milestone, with topline data expected in early 2026, indicating potential for the first commercial product for the company [1][2] - The company is advancing multiple Phase 3 programs for azetukalner in neuropsychiatric disorders, including major depressive disorder (MDD) and bipolar depression (BPD) [2][3] - The company appointed Darren Cline as Chief Commercial Officer to lead the commercial strategy for the anticipated launch of azetukalner [1][9] Clinical Development - Azetukalner is a selective Kv7 potassium channel opener, currently in late-stage clinical development for epilepsy and neuropsychiatric disorders [3][18] - The Phase 3 X-TOLE2 study for focal onset seizures (FOS) has completed patient recruitment, while X-CEED for BPD has recently been initiated [6][17] - Ongoing Phase 1 studies for Nav1.7 and Kv7 candidates are targeting pain management, with the potential for broader therapeutic applications [13][18] Financial Performance - As of June 30, 2025, the company reported cash and cash equivalents of $624.8 million, down from $754.4 million at the end of 2024, indicating a need for careful cash management as clinical trials progress [14] - Research and development expenses for Q2 2025 were $75.0 million, an increase from $49.7 million in Q2 2024, primarily due to ongoing clinical trials for azetukalner [14][23] - The net loss for Q2 2025 was $84.7 million, compared to $57.9 million in the same period of 2024, reflecting increased operational costs associated with clinical development [14][23] Upcoming Milestones - The company anticipates topline results from the Phase 3 X-TOLE2 study in early 2026, which could lead to regulatory submissions and potential product approval [2][6] - Multiple abstracts related to the company's epilepsy programs have been accepted for presentation at the 36th International Epilepsy Congress in late August 2025 [6] - The company plans to host R&D webinars focusing on early-stage pipeline programs, with the first scheduled for October 2, 2025 [13]