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Xenon Stock at $42: What to Know of a $75 Million Trim Ahead of March Phase 3 Data
Yahoo Finance· 2026-02-19 22:41
Connecticut-based Braidwell disclosed a sale of 1,779,953 shares of Xenon Pharmaceuticals (NASDAQ:XENE) in its February 17, 2026, SEC filing, an estimated $74.76 million trade based on quarterly average pricing. What happened According to a SEC filing dated February 17, 2026, Braidwell reduced its position in Xenon Pharmaceuticals by 1,779,953 shares. The estimated transaction value was $74.76 million, based on the mean unadjusted closing price during the fourth quarter of 2025. At quarter-end, the stake ...
Xenon Pharmaceuticals (NasdaqGM:XENE) FY Conference Transcript
2026-01-12 18:02
Xenon Pharmaceuticals FY Conference Summary Company Overview - **Company**: Xenon Pharmaceuticals (NasdaqGM:XENE) - **Event**: 44th Annual J.P. Morgan Healthcare Conference - **Date**: January 12, 2026 - **Key Presenters**: Ian Mortimer (President and CEO), Chris Kenny (Chief Medical Officer), Darren Kline (Chief Commercial Officer), Tucker Kelly (CFO) [1][2] Core Focus Areas Lead Molecule: Azetukalner - **Indications**: Developed for epilepsy and neuropsychiatry - **Clinical Development**: Most advanced potassium channel modulator in late-stage clinical development with over 800 patient years of efficacy and safety data [3][4] - **Dosing**: Once-daily dosing with no titration required, which is a significant advantage over other CNS drugs [5] Epilepsy Market Insights - **Prevalence**: Epilepsy is the fourth most common neurological condition, with a lifetime risk of 1 in 26 [6] - **Patient Population**: Approximately 3 million Americans have epilepsy, with focal onset seizures representing about 60% of the market [6][7] - **Unmet Need**: About half of epilepsy patients are not receiving adequate treatment, indicating a significant market opportunity for azetukalner [7][8] Clinical Trial Updates - **Phase IIb Trial (X-TOLE)**: Randomized 325 subjects, showing a 52.8% reduction in seizures at the highest dose (25 mg) with significant statistical significance (P < 0.05) [9][10] - **Open-Label Extension**: Patients showed over 90% reduction in seizure burden over 48 months, with nearly 40% achieving 12 months of seizure freedom [13][15] - **Phase III Trials**: Two parallel trials (X-TOLE2 and X-TOLE3) for focal onset seizures, with the first readout expected in March 2026 [19][20] Neuropsychiatry Development - **Major Depressive Disorder (MDD)**: A smaller phase II study showed a clear dose response with rapid onset of efficacy, leading to ongoing phase III trials [22][27] - **Bipolar Depression**: New study (EXCED) initiated to address this significant unmet need [27] Early-Stage Pipeline - **Nav1.7 Program**: Focused on a novel analgesic targeting pain pathways, currently in phase I clinical trials [28][29] - **Genetic Insights**: The program leverages genetic findings related to the SCN9A gene, which is linked to pain perception [29][30] Strategic Objectives - **Integration**: Aim to become a fully integrated biopharma company, focusing on discovering, developing, and commercializing proprietary molecules [36][38] - **Market Positioning**: Emphasis on building a strong commercial team with deep epilepsy experience to ensure successful product launch [55][56] Key Takeaways - **Market Opportunity**: Significant unmet medical needs in both epilepsy and neuropsychiatry present a strong market opportunity for azetukalner [8][27] - **Clinical Confidence**: Robust clinical data supports the efficacy and safety of azetukalner, positioning it as a potential first-line treatment in its categories [18][19] - **Future Outlook**: Successful outcomes in ongoing trials could lead to a substantial expansion of Xenon's portfolio and market presence in the coming years [59][62]
BridgeBio Pharma (NasdaqGS:BBIO) FY Conference Transcript
2026-01-12 16:32
Summary of BridgeBio Pharma FY Conference Call Company Overview - **Company**: BridgeBio Pharma (NasdaqGS:BBIO) - **Event**: 44th Annual J.P. Morgan Healthcare Conference - **Date**: January 12, 2026 - **CEO**: Neil Kumar Key Points Company Milestones - BridgeBio celebrates its 10th anniversary, having developed a highly efficient R&D engine for genetic diseases with three approved products and three more expected in the next 12 months [2][3] - Nearly 20 Investigational New Drug (IND) applications generated, impacting approximately 10,000 patient lives [3] Financial Performance - Q4 revenue pre-announced at **$146 million**, representing a **35% growth** from the previous quarter and suggesting a **60% compound annual growth rate (CAGR)** [4] - Total revenue for the first four quarters reached **$362 million** [5] - The company aims for a **30%-35% peak year market share** by volume for its product Attruby, with over **25% market share** achieved in the first year [5] Product Updates ATTR Cardiomyopathy - Attruby is the first and only near-complete stabilizer approved by the FDA, showing a **42% relative risk reduction** in all-cause mortality and cardiovascular hospitalization at 30 months [6] - Over **50 publications** and abstracts have been released regarding the drug's efficacy and patient population performance [6] Limb-Girdle Muscular Dystrophy Type 2I (LGMD2I) - Interim phase three results showed a **1.8 times increase** in glycosylation of the alpha-dystroglycan complex and an **82% decrease** in muscle damage [15] - Statistically significant improvements in ambulation and breathing were observed, indicating potential therapeutic cures for some patients [16] ADH1 - Phase 3 results indicated a **76% responder rate** for normalization of urine and serum calcium levels, significantly outperforming the standard of care [20] - The company has identified **1,700 unique patients** with ADH1 through improved genetic testing and updated guidelines [24] Chronic Hypoparathyroidism - A trial showed **80% normalization** of urine and serum calcium levels, with plans to initiate the Reclaim HP trial mid-year [26] Achondroplasia and Hypochondroplasia - The company is advancing its small molecule program targeting FGFR3 over-activation, with phase three data expected in Q1 [28][29] Canavan Disease - A gene therapy approach is being developed, with a BLA filing anticipated in 2027 [36] Market Strategy - The company employs a decentralized model for product launches, leveraging existing infrastructure to minimize costs [37] - Market research indicates a potential **52% market share** for its new products based on favorable profiles compared to existing treatments [34] Future Outlook - BridgeBio emphasizes that it is still "day one" in the era of genetic medicine, with ongoing advancements in genetic research and therapeutic development [38][39] - The company is focused on identifying new patient populations and expanding its pipeline, with **17 early-stage programs** in development at Gondola Bio [40] Conclusion - BridgeBio is well-financed and positioned for significant growth, aiming to serve more patients with innovative therapies in the coming years [48]
Xenon Outlines Key Upcoming Milestones at the 2026 J.P. Morgan Healthcare Conference
Globenewswire· 2026-01-12 13:30
Core Insights - Xenon Pharmaceuticals Inc. is advancing its Phase 3 portfolio, particularly focusing on azetukalner for epilepsy and neuropsychiatry, with significant milestones expected in the near future [1][2] Phase 3 Azetukalner Program in Epilepsy & Depression - The topline data for the X-TOLE2 Phase 3 study of azetukalner in focal onset seizures (FOS) is anticipated in March 2026, followed by a New Drug Application (NDA) submission in the second half of 2026 [4] - Five additional Phase 3 studies of azetukalner are ongoing, targeting various indications in epilepsy and neuropsychiatry, with topline data from the X-NOVA2 study in major depressive disorder (MDD) expected in the first half of 2027 [4][5] - The X-TOLE2 study has completed enrollment with 380 patients, and the data collected will support the upcoming topline readout [5] Broader Pipeline Opportunity - Azetukalner is a novel KV7 potassium channel opener, currently in late-stage clinical trials for epilepsy, MDD, and bipolar depression (BPD), representing a significant advancement in treatment options [7][10] - The company is also developing early-stage candidates targeting NaV1.7 and KV7 for pain management, with preliminary Phase 1 data expected in 2026 to support Phase 2 studies [11][12] About Epilepsy and Focal Onset Seizures - Epilepsy affects approximately 3 million adults in the U.S., with focal onset seizures being a common form that presents a substantial unmet medical need due to the inadequacy of existing treatments for many patients [9]
Xenon to Present at the 44th Annual J.P. Morgan Healthcare Conference
Globenewswire· 2026-01-05 13:30
Core Insights - Xenon Pharmaceuticals Inc. will present at the 44th Annual J.P. Morgan Healthcare Conference from January 12-15, 2026, in San Francisco, CA [1] - The presentation will be led by Ian Mortimer, President and CEO, and will be available via live audio webcast [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 [3] - 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) [3] - Xenon is also developing an early-stage portfolio of potassium and sodium channel modulators, including Kv7 and NaV1.7 programs in Phase 1 for potential pain treatment [3]
H.C. Wainwright Maintains Neutral Stance on Biohaven After BHV-7000 Setback
Financial Modeling Prep· 2025-12-26 18:27
Core Viewpoint - H.C. Wainwright reiterated a Neutral rating and $11 price target on Biohaven Pharmaceutical Holding Co. following disappointing clinical results for BHV-7000 in major depressive disorder [1] Group 1: Clinical Trial Results - The study for BHV-7000 failed to meet its primary endpoint of improvement in MADRS scores over six weeks compared to placebo [3] - Secondary endpoints, including CGI-S and SHAPS, were also missed in the trial [3] - Biohaven plans to conduct additional subgroup analyses, but these will be exploratory only, with no further trials planned for the program [3] Group 2: Market Focus and Future Directions - Investor attention has largely shifted to the upcoming focal onset seizure readout, with some investors hoping for positive MDD data as a catalyst [2] - Biohaven intends to redirect focus toward priority areas in 2026, including immunology, obesity, and epilepsy [4] - The results of BHV-7000 did not materially affect expectations for Xenon Pharmaceuticals' azetukalner Phase 3 MDD program [4]
Xenon Pharmaceuticals (NasdaqGM:XENE) Earnings Call Presentation
2025-12-10 15:00
Azetukalner Efficacy and Safety - Azetukalner demonstrated a 90.9% median percent change (MPC) reduction in monthly focal onset seizure (FOS) frequency after 48 months in the open-label extension (OLE) [92] - A subset of patients receiving 1-2 anti-seizure medications (ASMs) at double-blind period (DBP) baseline experienced a 100% monthly reduction in FOS frequency [92] - 38% of patients treated with azetukalner for at least 48 months achieved seizure freedom for one year or longer [92] - Azetukalner's safety and tolerability profile in the OLE remained consistent with the DBP [92, 73] - In the Phase 2b X-TOLE study, azetukalner showed statistically significant and dose-dependent seizure reduction, with up to a 52.8% median percent change from baseline [34] Commercial Opportunity and Market Insights - Xenon Pharmaceuticals has $555.3 million in cash, cash equivalents, and marketable securities as of September 30, 2025, with anticipated cash runway into 2027 [18] - An estimated 2.6 million adults in EU4 + UK, 3.0 million in Japan, and 0.8 million in the U.S have diagnosed epilepsy [95] - Focal onset seizures (FOS) represent the largest segment of the epilepsy population [95] - Up to 50% of epilepsy patients may require additional treatment options, presenting a significant commercial opportunity [102, 97] Clinical and Patient Burden - Depression is a significant burden for patients with FOS, highlighting the need for therapeutics that do not exacerbate mood disorders [92, 79] - Titration of anti-seizure medications (ASMs) poses a significant burden for both patients and healthcare professionals (HCPs), underscoring the need for simplified or no-titration ASMs [92, 87]
Xenon Showcases New 48-Month Azetukalner OLE Study Data in Epilepsy at AES 2025
Globenewswire· 2025-12-05 14:00
Core Insights - Xenon Pharmaceuticals Inc. announced new data on its commitment to epilepsy treatment, including interim 48-month data from the X-TOLE open-label extension study of azetukalner, real-world studies on depression burden, and pre-clinical data for Dravet syndrome [1][2] Group 1: Azetukalner Efficacy and Safety - The interim data from the X-TOLE study showed a monthly seizure frequency reduction of over 90% at 48 months, with a 100% reduction in patients on 1-2 anti-seizure medications (ASMs) at baseline [2][4] - Among participants treated for 48 months, 38.2% achieved at least 12 months of seizure freedom, while 10.7% maintained seizure freedom for 48 months [4] - The long-term safety profile of azetukalner was consistent with that observed during the double-blind period, indicating a favorable tolerability [5] Group 2: Real-World Studies on Depression in Epilepsy - A study found that 80.6% of patients with focal seizures reported depressed mood, highlighting the significant mental health burden among this population [7] - Newly diagnosed epilepsy patients with depression had a higher prevalence of comorbidities and an increased risk of treatment failure, emphasizing the need for tailored treatment strategies [8] - Patients with moderate to severe depression symptoms experienced a lower quality of life and higher healthcare resource utilization, reinforcing the necessity for routine depression screening in epilepsy care [9] Group 3: Pipeline and Future Directions - Xenon is preparing to share Phase 3 data from the X-TOLE2 study in early 2026, which is anticipated to be a significant milestone for the company and the epilepsy community [2] - The company is also advancing early-stage programs targeting potassium and sodium channels for potential pain treatment, indicating a broadening of its therapeutic focus [15]
Why Is Xenon Pharmaceuticals (XENE) Up 9.7% Since Last Earnings Report?
ZACKS· 2025-12-03 17:36
Core Viewpoint - Xenon Pharmaceuticals reported a narrower loss than expected for Q3 2025, with shares increasing by approximately 9.7% since the last earnings report, outperforming the S&P 500 [1][3]. Financial Performance - The company reported a loss of $1.15 per share for Q3 2025, which was better than the Zacks Consensus Estimate of a loss of $1.16, compared to a loss of $0.81 per share in the same quarter last year [3]. - Xenon did not generate any revenues in the reported quarter, similar to the year-ago quarter, as it lacks a marketed product and only recognizes collaboration revenues from its partnership with Neurocrine Biosciences [4]. - Research and development (R&D) expenses rose by 35% year-over-year to $77.1 million, driven by costs related to late-stage studies in epilepsy and major depressive disorder (MDD), as well as increased personnel expenses [5]. - General and administrative expenses increased by 16% year-over-year to $19.3 million, primarily due to higher professional and consulting fees [6]. - As of September 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $555.3 million, down from $624.8 million as of June 30, 2025, which is expected to fund operations through 2027 [7]. Market Sentiment and Estimates - Estimates for Xenon Pharmaceuticals have trended upward over the past month, indicating a positive outlook despite the current Zacks Rank of 3 (Hold) [8][10]. - The company has a poor Growth Score of F and a Momentum Score of C, with an overall VGM Score of F, placing it in the bottom 20% for value investors [9]. Industry Comparison - Xenon Pharmaceuticals is part of the Zacks Medical - Biomedical and Genetics industry, where BioMarin Pharmaceutical (BMRN) has seen a 2.6% gain over the past month, reporting revenues of $776.13 million for the last quarter, a year-over-year increase of 4.1% [11][12].
Xenon Announces Investor Webinar Highlighting Azetukalner and Epilepsy Data from AES 2025
Globenewswire· 2025-12-03 13:30
Core Insights - Xenon Pharmaceuticals Inc. is hosting an investor webinar on December 10, 2025, to present data from the American Epilepsy Society Annual Meeting, focusing on long-term data from the X-TOLE study of azetukalner and real-world data on depression in epilepsy [1][2] - Azetukalner is a novel Kv7 potassium channel opener currently in Phase 3 clinical trials for epilepsy, major depressive disorder, and bipolar depression [3] Company Overview - Xenon Pharmaceuticals is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of therapeutics [3] - The company is advancing a portfolio of potassium and sodium channel modulators, including Kv7 and Nav1.7 programs in Phase 1 development for pain treatment [3] Webinar Details - The webinar will take place from 10:00 to 11:00 AM Eastern Time, with a live webcast available on the company's website [2] - Participants can submit questions via chat during the webinar or in advance via email [2]