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Xenon Pharmaceuticals (NasdaqGM:XENE) FY Conference Transcript
2026-01-12 18:02
Xenon Pharmaceuticals (NasdaqGM:XENE) FY Conference January 12, 2026 12:00 PM ET Company ParticipantsIan Mortimer - President and CEOChristopher Kenney - CMOConference Call ParticipantsTessa Romero - Senior Biotech AnalystTessa RomeroWelcome, everyone, to the 44th Annual J.P. Morgan Healthcare Conference. My name is Tess Romero, and I'm one of the Senior Biotech Analysts here at J.P. Morgan. Our next presenting company is Xenon Pharmaceuticals, and presenting on behalf of the company, we have President and ...
BridgeBio Pharma (NasdaqGS:BBIO) FY Conference Transcript
2026-01-12 16:32
BridgeBio Pharma (NasdaqGS:BBIO) FY Conference January 12, 2026 10:30 AM ET Company ParticipantsDarren Cline - Chief Commercial OfficerIan Mortimer - President and CEONeil Kumar - CEOChris Kenney - Chief Medical OfficerConference Call ParticipantsTess Romero - Senior Biotech AnalystAnupam Rama - Senior Biotech AnalystAnupam RamaAll right, welcome everyone to the 44th annual J.P. Morgan Healthcare Conference. My name is Anupam Rama. I'm one of the Senior Biotech Analysts here at JPMorgan. I'm joined by my sq ...
Xenon Outlines Key Upcoming Milestones at the 2026 J.P. Morgan Healthcare Conference
Globenewswire· 2026-01-12 13:30
Phase 3 X-TOLE2 topline data for azetukalner in FOS expected March 2026 followed by anticipated NDA submission in H2 2026Five additional Phase 3 azetukalner studies continuing to enroll patients in multiple indications in epilepsy and neuropsychiatry; Phase 3 X-NOVA2 topline data in MDD expected in H1 2027 Data from two Phase 1 studies of novel NaV1.7 (XEN1701) and KV7 (XEN1120) candidates expected in 2026 to support Phase 2 proof-of-concept studies in pain VANCOUVER, British Columbia and BOSTON, Jan. 12, ...
Xenon to Present at the 44th Annual J.P. Morgan Healthcare Conference
Globenewswire· 2026-01-05 13:30
VANCOUVER, British Columbia and BOSTON, Jan. 05, 2026 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq: XENE), a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development and commercialization of life-changing therapeutics for patients in need, today announced that the company will present at the 44th Annual J.P. Morgan Healthcare Conference, taking place in San Francisco, CA from January 12-15, 2026. Company Presentation Details: Date:Monday, January 12, 2026 T ...
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]
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]