Neurocrine Biosciences, Inc.

Advocacy leaders rank Janssen, Otsuka, Neurocrine, and BMS at the top—while calling out gaps in access, affordability, and equity MOUNT PLEASANT, SC, UNITED STATES, August 27, 2025 / EINPresswire.com / -- Archo Advocacy today announced the release of the 2025 ELAVAY Advocacy Intelligence Mental Health Report, the industry’s only syndicated benchmark built from direct input from mental health advocacy organizations, professional societies, and community-based groups. ELAVAY highlights the trusted advocacy leaders and points out where the industry falls short in serving patients. The report assesses companies across the ten most critical advocacy functions in mental health: Partnerships & Program Support, Government Policy Engagement, Corporate Reputation, Expanding Access & Education, Advocacy & Community Relationships, Diversity, Equity & Inclusion, and Health Equity & SDOH. It also evaluates industry performance on urgent patient issues, including Non-Medical Switching, Patient Assistance Programs, Patient-Focused Medicine Development, and policy response in a volatile political climate. Top Performers in Mental Health Patient Advocacy: Janssen once again leads in Partnerships & Program Support and Corporate Reputation. Otsuka closely follows with excellent scores in coalition building and research collaboration. Neurocrine Biosciences jumps into the top tier, ranking third in Partnerships & Programs Support and second in Corporate Reputation, praised for transparency and patient engagement. This is a big move for Neurocrine and shows it commitment in Mental Health advocacy as they move to 3rd place this year after ranking 6th last year. Lundbeck rises to fourth place, driven by high marks in trial collaboration and sharing scientific information. Bristol-Myers Squibb enters the top five with strong patient education and effective integration of lived experience. Other leaders include Takeda, Sage Therapeutics, and Teva for their equity-focused education initiatives; Boehringer Ingelheim, Myriad, and Biogen Idec for influencing state-level policy discussions; and Pfizer/Seagen, Blue Cross Blue Shield, and Aetna/CVS Health for their efforts in expanding patient education and access. Persistent Gaps: Despite these advances, the data reveal significant gaps in support. Urgent action is needed to address these gaps to maximize patient care. • Patient Access Support: Organizations rated industry support at 4.0, while the preferred level is 5.8. Patients still face barriers to access. • Financial Support Initiatives: Companies achieved a score of 3.5, compared to an expected score of 5.0. Patients and their families struggle to obtain the medications they need. • Evidence-Based Care Guidelines: Current support scores 4.4, falling short of the desired 5.5. Patients often experience inconsistent and fragmented care, lacking a strong advocate for change. • Non-Medical Switching: 75% of advocates report that insurer-driven medication changes are harming patients. This isn’t a minor issue; it directly threatens stability and health outcomes. • Health Literacy: Half of advocacy leaders report that patients still struggle to understand the materials provided by companies. Complex language hampers comprehension. While the average literacy level of mental health patients is roughly at a 6th-grade level—above that of many other conditions—patients need more relevant materials and social support groups to foster community and provide help when needed. The Line in the Sand: The findings are clear: advocacy is not a side project. It is the strategy that determines whether patients trust your company or fight against it. Teams that ranked high in this report are embedding patient voice early and consistently. Those who did not are still guessing. “Too many companies still check the box and call it patient centricity,” said Matt Toresco , CEO of Archo Advocacy. “The leaders in this report aren’t perfect, but they’ve shown up. The rest of the industry needs to stop pretending and start closing the gaps that patients live with every day.” The ELAVAY Mental Health Report makes one thing clear: advocacy is not optional. It’s the difference between being trusted and being irrelevant. Stop guessing if your strategy is working. Get the data. See where you stand. And fix it. Purchase the ELAVAY Mental Health Report and see the receipts. Find out exactly where your advocacy strategy is winning, where it is failing, and how to fix it before your competition does. Subscribers gain access to: • Custom benchmarking dashboards • A whole year of complimentary strategic consulting • Tailored support for DE&I alignment, health equity, and stakeholder trust-building To subscribe to the ELAVAY Report and receive your mental health advocacy performance dashboard, visit www.elavayreport.com or contact info@archo.io. About ELAVAY Developed by Archo Advocacy, ELAVAY is the industry’s only syndicated benchmark powered by Advocacy Intelligence—a new standard for evaluating healthcare companies through the eyes of patient advocates, policy leaders, and nonprofit organizations. Advocacy Intelligence bridges the gap between corporate strategy and community trust by translating qualitative stakeholder insight into quantifiable, executive-ready metrics. ELAVAY captures performance across five critical pillars: Partnership & Program Support, Policy Activities, Health Equity, Access & Education, and Community Relationships. These insights are sourced through both qualitative interviews and quantitative surveys from an invite-only panel of national and regional advocacy leaders. In a landscape where credibility with patient and policy stakeholders determines market access, reputation, and long-term impact, ELAVAY equips companies with the clarity to act—not just on compliance, but on connection. It doesn’t just measure perception; it delivers the intelligence needed to lead with legitimacy. Learn more at www.elavayreport.com or follow us on LinkedIn @ArchoAdvocacy. About Archo: At its core, Archo strives to give patients a voice & promote positive change in healthcare. Our platform offers a range of resources & support to empower patients & healthcare companies. With training, market research & advocacy, Archo educates the industry on the value of patient-directed care. Together with industry, Archo believes it can tackle today’s most pressing issues for patient care & keep the patient at the center of all healthcare decision-making. For more information, please contact: Hunter Fasanaro Director of Strategic Partnerships & Healthcare Initiatives Hunter.Fasanaro@archo.io / Elavay@archo.io Hunter Fasanaro Archo Advocacy, LLC +1 843-256-3902 email us here Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

NEW YORK, Aug. 25, 2025 /PRNewswire/ -- Antiseizure medications help the majority of people with focal epilepsy, a common form of the neurological disorder. Yet most will still have episodes for at least a year after their treatment begins, until their doctors can find the right drug and dosage for them, a new study shows. Continue Reading Accounting for about 60% of people with epilepsy, focal epilepsy occurs when nerve cells in a certain brain region send out a sudden, excessive burst of electrical signals. This uncontrolled activity, which is called a focal seizure, can cause problems such as abnormal emotions or feelings and unusual behaviors. Much attention has been paid to the minority of patients who do not respond well to available treatments, but the current study looks at another group: those who may not respond to the first medication or regimen prescribed, but perhaps to another tried later. A possible explanation is that physicians are not selecting the ideal antiseizure therapy on their first try. Post this Led by researchers at NYU Langone Health as part of the international Human Epilepsy Project, the study is among the first in a decade to focus on those whose seizures ultimately can be prevented or controlled with drugs. Results for nearly 450 men, women, and teens newly diagnosed with the disorder revealed that while more than half would eventually receive a medication or regimen that worked for them, major improvements were not achieved until an average of 12 months. Many needed even longer to find relief. "Our findings suggest that those with focal epilepsy should expect a long adjustment period as their health care provider determines the best treatment regimen for them," said study senior author and neurologist Jacqueline French, MD. A possible explanation for this delay is that physicians are not selecting the ideal antiseizure therapy on their first try, adds French, a professor in the Department of Neurology at the NYU Grossman School of Medicine and co-principal investigator of the Human Epilepsy Project. Neurologists commonly start patients on levetiracetam, a drug that can target many types of seizures and has few interactions with other medications. Based on the new results, however, they may want to rethink this approach, says French, noting that while 57% of the study participants were initially prescribed levetiracetam, only a quarter became seizure free on their first try. A report on the findings published online Aug. 25 in the journal JAMA Neurology. Thirty-four epilepsy centers in the United States, Europe, and Australia were involved in the study, which took place from 2012 to 2019. The team collected data about the patients' medical histories, demographic factors such as sex and race, and the details of their epilepsy diagnoses, including seizure frequency, the age of onset, and MRI readings. All were provided annual follow-ups for either three or six years. During this time, participants tracked their seizure frequency in an electronic diary, describing each day as either "seizure free" or "had a seizure." The time, duration, and type of episode, along with other notes, were also recorded. The study volunteers also reported information about their antiseizure medications, noting the type, dose, and reasons for discontinuing a regimen. Patients were considered seizure free if they did not have an episode for at least a year (or longer if their seizures were infrequent). The study further showed that together, 63% of all participants experienced ongoing or even worsening seizures during the first year of therapy, whether or not they would eventually find relief. Notably, those who had seizures only a few times per year prior to treatment were more likely to respond to medication than those who had them weekly. In addition, participants with a history of psychological disorders such as anxiety and depression were almost twice as likely to resist the drugs than those without such a history. "Our results show that the best way to a new treatment plan is sometimes through making better use of the tools we already have instead of always searching for the next breakthrough drug," said French, who is also a member of NYU Langone's Comprehensive Epilepsy Center. The researchers next plan to more closely examine those who did not become seizure free during the study period, says French. French cautions that the investigation did not directly assess the role of regimen choice, dose, or side effects on the way patients responded to treatment, and it did not exclude participants who failed to adhere to their prescribed regimen. The Human Epilepsy Project is a collaboration of hundreds of researchers, physicians, and other health care workers seeking new insight into how patients with the disorder respond to therapies and become seizure free. Funding for the study was provided by the Epilepsy Study Consortium, which receives support from pharmaceutical companies UCB, Eisai Co., Pfizer, Lundbeck., and Sunovion Pharmaceuticals Inc., as well as the Andrews Foundation, the John and Barbara Vogelstein Foundation, and Finding a Cure for Epilepsy and Seizures (FACES) — a nonprofit organization affiliated with the NYU Comprehensive Epilepsy Center. French also receives salary and research support from the Epilepsy Foundation and the Epilepsy Study Consortium. These organizations also covered fees for consulting or attending scientific advisory board meetings for Acadia Pharmaceuticals, Access Industries, Acuta Capital Partners, AfaSci, AgriThera, Alterity Therapeutics, Angelini Pharma, Autifony Therapeutics, Axonis Therapeutics, Beacon Biosignals, Biogen, Biohaven, Bloom Science, Bright Minds Biosciences, CAMP4, Capsida Biotherapeutics, Cerebral Therapeutics Inc., Cerecin Neurosciences, Cerevel Therapeutics, Ceribell, Cognizance Biomarkers, Cowen and Company, Crossject, EcoR1 Capital, Eisai Co., Encoded Therapeutics, Engrail, EpiMinder, Epitel, Équilibre BioPharmaceuticals Corp., Genentech, GRIN Therapeutics, Harmony Biosciences/Epygenix Therapeutics Inc., iQure Pharma, IQVIA, Janssen Pharmaceutica, Jazz Pharmaceuticals, Korro Bio, Leal Therapeutics, LivaNova, Longboard Pharmaceuticals, Marinus Pharmaceuticals, Modulight Bio, Neumirna Therapeutics, Neurelis, Neurocrine Biosciences, Neurona Therapeutics, NeuroPace, NeuroPro Therapeutics, Neuroventis, Neurvati, Noema Pharma, Ono Pharmaceutical Co., Otsuka, Ovid Therapeutics, Praxis Precision Medicines, PureTech Health, Rapport Therapeutics, Receptor Holdings Inc., RiverVest, Sage Therapeutics, SK Life Science, Stoke Therapeutics, Supernus Pharmaceuticals, Takeda Pharmaceuticals, Taysha Gene Therapies, Third Rock Ventures, UCB, uniQure, Ventus Therapeutics, Vida Ventures, and Xenon Pharmaceuticals Inc. French has received additional research support from FACES, the One8 Foundation, the National Institute of Neurological Disorders and Stroke, and Praxis Precision Medicines. French serves on the editorial boards of "The Lancet Neurology" and "Neurology Today" and is the chief medical/innovation officer for the Epilepsy Foundation. She is the president and serves on the board of directors of the Epilepsy Study Consortium, and she has received travel/meal reimbursement related to research, advisory meetings, and presentation of results at scientific meetings from the Epilepsy Study Consortium, the Epilepsy Foundation, Biohaven Pharmaceuticals, Cerebral Therapeutics, Cowen and Company, Longboard Pharmaceuticals, Neumirna Therapeutics, Neurocrine Biosciences, NeuroPace, Neurvati, Praxis Precision Medicine, Rapport Therapeutics, SK Life Science, Takeda Pharmaceuticals, Ventus Therapeutics, and Xenon Pharmaceuticals Inc. The terms and conditions of all of these relationships are being managed by NYU Langone. Along with French, Ruben Kuzniecky, MD, at Northwell Health in New York City, and Daniel Lowenstein, MD, at the University of California, San Franscisco, are study co-senior authors and are co-principal investigators of the Human Epilepsy Project. Other study co-investigators are Sarah Barnard, MD, MPH, and Zhibin Chen, PhD, at Monash University in Melbourne, Australia; Manisha Homes, M.D., at New York Medical College in Valhalla; Andres Kanner, M.D., at the University of Miami in Florida; and Manu Hegde, MD, PhD, at the University of California, San Franscisco. About NYU Langone Health NYU Langone Health is a fully integrated health system that consistently achieves the best patient outcomes through a rigorous focus on quality that has resulted in some of the lowest mortality rates in the nation. Vizient, Inc. has ranked NYU Langone number one out of 115 comprehensive academic medical centers across the nation for three years in a row, and U.S. News & World Report recently ranked four of its clinical specialties No. 1 in the nation. NYU Langone offers a comprehensive range of medical services with one high standard of care across seven inpatient locations, its Perlmutter Cancer Center, and more than 320 outpatient locations in the New York area and Florida. With $14.2 billion in revenue this year, the system also includes two tuition-free medical schools, in Manhattan and on Long Island, and a vast research enterprise. Media Inquiries Shira Polan Phone: 212-404-4279 [email protected] SOURCE NYU Grossman School of Medicine and NYU Langone Health WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

– Phase 3 azetukalner X-TOLE2 FOS study patient recruitment complete, with topline data anticipated in early 2026– Phase 3 azetukalner neuropsychiatric studies underway with X-NOVA3 in MDD and X-CEED in BPD recently initiated– Phase 1 healthy volunteer study initiated for lead Nav1.7 development candidate for pain– Darren Cline appointed as Chief Commercial Officer to lead commercial build and anticipated azetukalner launch– Conference call at 4:30 pm ET today VANCOUVER, British Columbia and BOSTON , Aug. 11, 2025 (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 reported financial results for the second quarter ended June 30, 2025 , and provided a business update. “The completion of patient recruitment for our Phase 3 X-TOLE2 study is a significant milestone in the development of azetukalner and keeps us on track to report topline results in early 2026 in anticipation of our first potential approval and commercial product as a company. We remain highly encouraged by the potential value proposition of azetukalner as a novel, next-generation treatment option for people living with the debilitating effects of uncontrolled seizures,” said Ian Mortimer , President and Chief Executive Officer of Xenon. “In addition, we remain excited about azetukalner’s potential beyond epilepsy, with Phase 3 programs underway across multiple neuropsychiatric indications, with the initiation of our Phase 3 X-CEED study in bipolar depression, alongside two clinical studies now underway in our ongoing Phase 3 X-NOVA program in major depressive disorder.” “We also continue to make significant progress within our early-stage portfolio, advancing multiple drug candidates targeting promising sodium and potassium channel targets, and we are currently conducting two first-in-human studies within our Kv7 and Nav1.7 programs. As we enter this catalyst-rich period, we remain focused on advancing and delivering innovative therapeutics to patients living with epilepsy, depression, and pain.” continued Mr. Mortimer . Business Highlights and Anticipated Milestones Azetukalner Clinical Development Azetukalner, a novel, highly potent, selective Kv7 potassium channel opener, represents the most advanced, clinically validated potassium channel modulator in late-stage clinical development for the treatment of multiple indications that include epilepsy, including focal onset seizures (FOS) and primary generalized tonic-clonic seizures (PGTCS), as well as neuropsychiatric disorders including major depressive disorder (MDD) and bipolar depression (BPD). Epilepsy Programs Phase 3 X-TOLE2 clinical study of azetukalner in FOS has now completed patient recruitment, with topline data anticipated in early 2026. Phase 3 X-TOLE3 clinical study of azetukalner in FOS continues to enroll patients and is intended to support potential regulatory submissions in ex- U.S. jurisdictions. Phase 3 X-ACKT clinical study of azetukalner in PGTCS continues to enroll patients and is intended to support regulatory submissions for an additional epilepsy indication. The Company had four abstracts accepted to present at the 36th International Epilepsy Congress (IEC) taking place August 30 to September 3, 2025 in Lisbon, Portugal . Phase 3 X-TOLE2 clinical study of azetukalner in FOS has now completed patient recruitment, with topline data anticipated in early 2026. Phase 3 X-TOLE3 clinical study of azetukalner in FOS continues to enroll patients and is intended to support potential regulatory submissions in ex- U.S. jurisdictions. Phase 3 X-ACKT clinical study of azetukalner in PGTCS continues to enroll patients and is intended to support regulatory submissions for an additional epilepsy indication. Neuropsychiatric Programs X-NOVA2 and X-NOVA3, the first two of three planned Phase 3 clinical trials evaluating azetukalner in patients with MDD, are now underway and screening patients. X-CEED, the first of two planned Phase 3 clinical studies evaluating azetukalner in patients with BPD I and BPD II depression, has been initiated. X-NOVA2 and X-NOVA3, the first two of three planned Phase 3 clinical trials evaluating azetukalner in patients with MDD, are now underway and screening patients. X-CEED, the first of two planned Phase 3 clinical studies evaluating azetukalner in patients with BPD I and BPD II depression, has been initiated. Early-Stage Pipeline: Next-Generation Ion Channel Modulators Xenon continues to expand its portfolio by leveraging its extensive expertise to discover and develop potassium and sodium channel therapeutics, with the goal of filing multiple INDs, or equivalent, in 2025. Phase 1 study in healthy adult participants is underway for XEN1120, a Kv7 channel opener in development for pain. Work remains ongoing with additional Kv7 development molecules and chemistries with the hypothesis that Kv7 may have utility in a broad range of therapeutic indications including seizure disorders, pain, and neuropsychiatric disorders, such as MDD and BPD. Phase 1 study was initiated for XEN1701, the Company’s lead Nav1.7 development candidate for pain. IND-enabling work remains ongoing for additional Nav1.7 candidates. Nav1.7 is an important pain-related target, based on strong human genetic validation, which may represent a new class of medicines without the limitations of opioids. Nav1.1 lead candidate is expected to enter IND-enabling studies in 2025, with pre-clinical data suggesting that targeting Nav1.1 could potentially address the underlying cause and symptoms of Dravet Syndrome. Xenon plans to host multiple R&D webinars with focus on early-stage pipeline programs. The first webinar will take place on October 2, 2025 , and focus on our approach to treating pain with drug candidates targeting Nav1.7 and Kv7. Phase 1 study in healthy adult participants is underway for XEN1120, a Kv7 channel opener in development for pain. Work remains ongoing with additional Kv7 development molecules and chemistries with the hypothesis that Kv7 may have utility in a broad range of therapeutic indications including seizure disorders, pain, and neuropsychiatric disorders, such as MDD and BPD. Phase 1 study was initiated for XEN1701, the Company’s lead Nav1.7 development candidate for pain. IND-enabling work remains ongoing for additional Nav1.7 candidates. Nav1.7 is an important pain-related target, based on strong human genetic validation, which may represent a new class of medicines without the limitations of opioids. Nav1.1 lead candidate is expected to enter IND-enabling studies in 2025, with pre-clinical data suggesting that targeting Nav1.1 could potentially address the underlying cause and symptoms of Dravet Syndrome. Xenon plans to host multiple R&D webinars with focus on early-stage pipeline programs. The first webinar will take place on October 2, 2025 , and focus on our approach to treating pain with drug candidates targeting Nav1.7 and Kv7. Partnered Program As part of Xenon’s ongoing collaboration with Neurocrine Biosciences, a Phase 1 study is underway 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. As part of Xenon’s ongoing collaboration with Neurocrine Biosciences, a Phase 1 study is underway 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. Corporate The Company appointed Darren Cline to Chief Commercial Officer (CCO). Cline brings extensive commercial expertise to lead the transition of Xenon to a commercial-stage company with the anticipated launch of azetukalner across three potential indications. Second Quarter Financial Results Cash and cash equivalents and marketable securities were $624.8 million as of June 30, 2025 , compared to $754.4 million as of December 31, 2024 . Based on current operating plans, including the completion of the azetukalner Phase 3 epilepsy studies and supporting late-stage clinical development of azetukalner in MDD and BPD, Xenon anticipates having sufficient cash to fund operations into 2027. As of June 30, 2025 , there were 76,939,811 common shares and 2,173,081 pre-funded warrants outstanding. Research and development expenses for the quarter ended June 30, 2025 were $75.0 million , compared to $49.7 million for the same period in 2024. The increase of $25.3 million was primarily attributable to the ongoing azetukalner Phase 3 clinical trials in epilepsy and MDD, as well as start-up costs for the azetukalner Phase 3 BPD clinical trial, and increased personnel-related costs due to an increase in employee headcount. General and administrative expenses for the quarter ended June 30, 2025 were $19.2 million , compared to $19.4 million for the same period in 2024. Other income for the quarter ended June 30, 2025 was $8.9 million , compared to $10.8 million for the same period in 2024. The decrease of $2.0 million was primarily attributable to lower interest income, partially offset by an increase in foreign exchange gain. Net loss for the quarter ended June 30, 2025 was $84.7 million , compared to $57.9 million for the same period in 2024. The increase in net loss was primarily attributable to higher research and development expenses driven by the azetukalner program, increased personnel-related costs, and lower interest income. Cash and cash equivalents and marketable securities were $624.8 million as of June 30, 2025 , compared to $754.4 million as of December 31, 2024 . Based on current operating plans, including the completion of the azetukalner Phase 3 epilepsy studies and supporting late-stage clinical development of azetukalner in MDD and BPD, Xenon anticipates having sufficient cash to fund operations into 2027. As of June 30, 2025 , there were 76,939,811 common shares and 2,173,081 pre-funded warrants outstanding. Research and development expenses for the quarter ended June 30, 2025 were $75.0 million , compared to $49.7 million for the same period in 2024. The increase of $25.3 million was primarily attributable to the ongoing azetukalner Phase 3 clinical trials in epilepsy and MDD, as well as start-up costs for the azetukalner Phase 3 BPD clinical trial, and increased personnel-related costs due to an increase in employee headcount. General and administrative expenses for the quarter ended June 30, 2025 were $19.2 million , compared to $19.4 million for the same period in 2024. Other income for the quarter ended June 30, 2025 was $8.9 million , compared to $10.8 million for the same period in 2024. The decrease of $2.0 million was primarily attributable to lower interest income, partially offset by an increase in foreign exchange gain. Net loss for the quarter ended June 30, 2025 was $84.7 million , compared to $57.9 million for the same period in 2024. The increase in net loss was primarily attributable to higher research and development expenses driven by the azetukalner program, increased personnel-related costs, and lower interest income. Conference Call Information Xenon will host a conference call and webcast today at 4:30 pm Eastern Time ( 1:30 pm Pacific Time ) to discuss its second quarter 2025 results. A listen-only webcast can be accessed on the Investors section of the Xenon website, with a replay available following the event. Participants can access the conference call by dialing (800) 715-9871 or (646) 307-1963 for international callers and referencing conference ID 4102397. About Azetukalner Phase 3 Epilepsy Program Xenon’s Phase 3 epilepsy program includes three Phase 3 clinical trials in focal onset seizures (FOS) and primary generalized tonic-clonic seizures (PGTCS). Designed closely after the Phase 2b X-TOLE clinical trial, the Phase 3 X-TOLE clinical trials are multicenter, randomized, double-blind, placebo-controlled studies evaluating the clinical efficacy, safety, and tolerability of 15 mg or 25 mg of azetukalner administered orally with food as adjunctive treatment in approximately 360 patients with FOS per study. The primary efficacy endpoint is the median percent change (MPC) in monthly seizure frequency from baseline through the 12-week double-blind period (DBP) of azetukalner compared to placebo. X-ACKT is a multicenter, randomized, double-blind, placebo-controlled study evaluating the clinical efficacy, safety, and tolerability of 25 mg of azetukalner administered with food as adjunctive treatment in approximately 160 patients with PGTCS. The primary efficacy endpoint is the MPC in monthly PGTCS frequency from baseline through the 12-week DBP of azetukalner compared to placebo. Upon completion of the DBP in the Phase 3 epilepsy studies, eligible patients may enter an OLE study for up to three years. About Azetukalner Phase 3 MDD X-NOVA Program Xenon’s Phase 3 MDD program includes three multicenter, randomized, double-blind, placebo-controlled clinical trials to evaluate the clinical efficacy, safety, and tolerability of 20 mg of azetukalner administered orally with food over the 6-week double-blind period (DBP) as monotherapy treatment in approximately 450 patients with moderate-to-severe major depressive disorder (MDD) per study. The primary efficacy endpoint is the change from baseline in the HAM-D17 score at week 6 in patients who received azetukalner compared to placebo. Upon completion of the DBP, eligible patients may enter an open-label extension (OLE) study for up to 12 months. About Azetukalner Phase 3 BPD X-CEED Program Xenon’s Phase 3 BPD program includes two multicenter, randomized, double-blind, placebo-controlled clinical trials to evaluate the clinical efficacy, safety, and tolerability of 20 mg of azetukalner administered orally with food over the 6-week double-blind period (DBP) as monotherapy treatment in approximately 400 patients per study with bipolar depression (BPD) I or II. The primary efficacy endpoint is the change from baseline in the MADRS score at week 6 in patients who received azetukalner compared to placebo. Upon completion of the DBP, eligible patients may enter an OLE study for up to 12 months. About Xenon Pharmaceuticals Inc. Xenon Pharmaceuticals (Nasdaq: XENE) is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics for patients in need. Xenon’s lead molecule, azetukalner, is a novel, potent, selective Kv7 potassium channel opener in Phase 3 clinical trials for the treatment of epilepsy, major depressive disorder (MDD) and bipolar depression (BPD). Xenon is also advancing an early-stage portfolio of multiple promising potassium and sodium channel modulators, including Kv7 and Nav1.7 programs in Phase 1 development for the potential treatment of pain. Xenon has offices in Vancouver, British Columbia , and Boston , Massachusetts. For more information, visit www.xenon-pharma.com and follow us on LinkedIn and X. Safe Harbor Statement This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements are not based on historical fact, and include statements regarding the timing of and potential results from clinical trials; the potential efficacy, safety profile, future development plans in current and anticipated indications, addressable market, regulatory success and commercial potential of our and our partners’ product candidates; the efficacy of our clinical trial designs; our ability to successfully develop and achieve milestones in our azetukalner and other pipeline and development programs, including the anticipated filing of INDs and NDAs; the timing and results of our interactions with regulators; our ability to successfully develop and obtain regulatory approval of azetukalner and our other product candidates; and anticipated timing of topline data readout from our clinical trials of azetukalner. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events, or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: clinical trials may not demonstrate safety and efficacy of any of our or our collaborators’ product candidates; promising results from pre-clinical development activities or early clinical trial results may not be replicated in later clinical trials; our assumptions regarding our planned expenditures and sufficiency of our cash to fund operations may be incorrect; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; any of our or our collaborators’ product candidates, including azetukalner, may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; regulatory agencies may impose additional requirements or delay the initiation or completion of clinical trials; the impact of market, industry, and regulatory conditions on clinical trial enrollment; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; the impact of new or changing laws and regulations; the impact of unstable economic conditions in the general domestic and global economic markets; adverse conditions from geopolitical events; as well as the other risks identified in our filings with the U.S. Securities and Exchange Commission and the securities commissions in British Columbia , Alberta , and Ontario . These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements. “Xenon” and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner. Contacts: For Investors:Chad Fugere Vice President, Investor Relations(857) 675-7275investors@xenon-pharma.com For Media: Colleen Alabiso Senior Vice President, Corporate Affairs(617) 671-9238media@xenon-pharma.com Condensed Consolidated Balance Sheets(Expressed in thousands of U.S. dollars) , , Condensed Consolidated Statements of Operations and Comprehensive Loss(Expressed in thousands of U.S. dollars except share and per share amounts) Source: Xenon Pharmaceuticals Inc.