Welcome to the NeurologyLive® Mind Moments® podcast. Tune in to hear leaders in neurology sound off on topics that impact your clinical practice.

In this Mind Moments episode, Jessica Ailani, MD, director of the MedStar Georgetown Headache Center, discusses emerging phase 2 data on bocunebart (Lundbeck), a PACAP-targeting monoclonal antibody being developed for migraine prevention. Presented at the 2026 American Headache Society Annual Meeting, findings from the PROCEED trial demonstrated efficacy in patients with episodic or chronic migraine who had previously failed 1 to 4 preventive therapies, including those considered treatment refractory. 

The conversation explores the efficacy and safety findings from PROCEED, pooled analyses from chronic migraine populations, and a separate study evaluating coadministration of bocunebart with ubrogepant. Ailani also discusses the potential role of PACAP-targeting therapies within the evolving migraine treatment landscape, considerations for future combination strategies, and key questions investigators will need to address as the program moves toward phase 3 development. 

Looking for more Headache & migraine discussion? Check out the NeurologyLive® Headache & migraine clinical focus page.

Episode Breakdown:

• 1:10 – PROCEED trial efficacy in patients with prior preventive failures
• 5:10 – Safety and tolerability findings for bocunebart
• 6:30 – Coadministration data with ubrogepant and clinical implications
• 8:30 – Neurology News Network 
• 10:50 – Rationale for combining PACAP and CGRP-targeted therapies
• 13:40 – Key considerations for future phase 3 development

• Topline Phase 2 CELIA Results Show Diranersen Misses Primary End Point in Early Alzheimer Disease

• FDA Grants Priority Review to Bayer’s Asundexian for Secondary Stroke Prevention

• Dyne Submits BLA for Z-Rostudirsen in Exon 51 Skipping Duchenne Muscular Dystrophy

Welcome to the NeurologyLive® Mind Moments® podcast. Tune in to hear leaders in neurology sound off on topics that impact your clinical practice.

In this Mind Moments episode, Todd Arnedt, PhD, professor of psychiatry and neurology at Michigan Medicine-University of Michigan, joins the podcast to discuss the recently published American Academy of Sleep Medicine clinical practice guideline on combination treatment for chronic insomnia disorder in adults. Arnedt explains the rationale behind formal recommendations for concurrent use of cognitive behavioral therapy for insomnia (CBT-I) and pharmacotherapy, particularly as combination treatment becomes increasingly common in clinical practice. 

The conversation reviews the evidence supporting CBT-I as the preferred foundational treatment approach, where combination therapy may offer advantages over pharmacotherapy alone, and how clinicians should think about factors such as symptom burden, treatment goals, access to CBT-I, and patient preference when selecting treatment strategies. Arnedt also outlines ongoing research gaps involving sequential treatment approaches, medication classes, long-term outcomes, and personalized insomnia care. 

Looking for more Sleep Disorders discussion? Check out the NeurologyLive® Sleep Disorders clinical focus page.

Episode Breakdown:

• 1:15 – Why formal insomnia combination treatment guidance was needed
• 2:45 – Defining concurrent CBT-I and pharmacotherapy approaches
• 4:35 – Evidence supporting CBT-I as foundational insomnia treatment  
• 7:15 – Situations where combination therapy may improve patient outcomes
• 7:50 – Neurology News Network 
• 10:20 – Patient-specific factors influencing insomnia treatment selection
• 12:30 – Barriers involving CBT-I access, cost, and real-world implementation
• 16:55 – Research gaps surrounding sequencing, long-term outcomes, and personalization

• Topline Phase 2 CELIA Results Show Diranersen Misses Primary End Point in Early Alzheimer Disease

• FDA Grants Priority Review to Bayer’s Asundexian for Secondary Stroke Prevention

• Dyne Submits BLA for Z-Rostudirsen in Exon 51 Skipping Duchenne Muscular Dystrophy

Welcome to the NeurologyLive® Mind Moments® podcast. Tune in to hear leaders in neurology sound off on topics that impact your clinical practice.

In this Mind Moments episode, Scott Grossman, MD, assistant professor of neurology and ophthalmology at NYU Grossman School of Medicine, discusses emerging research on inter-eye retinal nerve fiber layer (RNFL) asymmetry as a biomarker of prior optic neuritis in pediatric-onset multiple sclerosis (POMS). Drawing from data presented at the 2026 American Academy of Neurology Annual Meeting, Grossman explains how optical coherence tomography (OCT) may help improve diagnostic confidence in pediatric MS by identifying remote optic nerve injury, while also outlining how a 4-micron inter-eye RNFL difference emerged as the optimal threshold in this cohort. The conversation also explores the role of OCT within the updated 2024 McDonald Criteria, the feasibility of integrating OCT into routine neurology practice, challenges surrounding normative pediatric OCT data, and future research directions involving visible light OCT and broader population datasets. 

Looking for more Multiple Sclerosis discussion? Check out the NeurologyLive® Multiple Sclerosis clinical focus page.

Episode Breakdown:

• 1:15 – Optic nerve involvement and updated MS diagnostic criteria 
• 3:20 – Pediatric RNFL asymmetry thresholds and interpretation of study findings
• 5:15 – Clinical implications of OCT biomarkers in pediatric-onset MS 
• 6:40 – Neurology News Network 
• 8:40 – Feasibility of incorporating OCT into neurology and MS practice 
• 10:15 – Future research directions, including normative data and visible light OCT

• FDA Approves AXS-05 as New Treatment for Alzheimer Disease Agitation

• FDA Approves Ocrelizumab for Pediatric Patients With Relapsing-Remitting Multiple Sclerosis

• Efgartigimod Gains FDA Approval as First Treatment for Seronegative Forms of Myasthenia Gravis

Welcome to the NeurologyLive® Mind Moments® podcast. Tune in to hear leaders in neurology sound off on topics that impact your clinical practice.

In this Mind Moments episode, Greg Pontone, MD, Chief of Aging Behavioral and Cognitive Neurology at the University of Florida, joins the podcast to discuss the interplay between cognition and Parkinson disease, with a focus on how clinicians can better recognize and manage cognitive changes across the disease course. Pontone outlines the prevalence of early cognitive impairment, noting that a significant proportion of patients may present with subtle deficits at diagnosis, particularly in executive function and processing speed. 

The conversation explores the impact of commonly used medications on cognition, including anticholinergics and benzodiazepines, and how clinicians can balance therapeutic benefit with cognitive risk. Pontone also reviews current treatment strategies, including cholinesterase inhibitors and memantine, while emphasizing the importance of nonpharmacologic approaches such as structured routines and cognitive training. Additional discussion highlights the evolving role of biomarkers, the overlap between Parkinson disease and Alzheimer pathology, and the need for earlier recognition, better patient education, and continued research to improve long-term cognitive outcomes in this population.

Looking for more Movement disorder discussion? Check out the NeurologyLive® Movement disorder clinical focus page.

Episode Breakdown:

• 1:10 – Prevalence and early signs of cognitive impairment in Parkinson disease 
• 2:30 – Medication-related cognitive effects and contributing drug classes
• 4:20 – Balancing therapeutic benefit vs cognitive risk in treatment decisions
• 6:05 – Current treatments for cognition, including pharmacologic and behavioral strategies
• 10:25 – Neurology News Network 
• 13:00 – Role of biomarkers and Alzheimer overlap in Parkinson cognition
• 15:45 – Future priorities for advancing cognitive care and research in PD

• FDA Clears Cala kIQ Plus for Essential Tremor and Parkinson Disease Hand Tremor

• FDA Issues Complete Response Letter for GTx-104 in Patients With Aneurysmal Subarachnoid Hemorrhage

• Satralizumab Meets Primary End Point in Phase 3 METEOROID Study in MOGAD

Welcome to the NeurologyLive® Mind Moments® podcast. Tune in to hear leaders in neurology sound off on topics that impact your clinical practice.

In this Mind Moments episode, Julie Kurek, MD, Associate Professor of Neurology at Augusta University/Wellstar-MCG, joins the podcast to provide a clinical breakdown of how neurologists can differentiate dyskinesia from tremor in patients with Parkinson disease and other movement disorders. Drawing from bedside experience, Kurek outlines the key phenomenologic differences between these movements, emphasizing the importance of rhythm, distribution, and overall movement quality in distinguishing the two. 

The conversation also explores how timing in relation to levodopa dosing serves as a critical diagnostic anchor, including recognition of peak-dose and biphasic dyskinesias. Kurek discusses real-world challenges in identifying patient-specific patterns, the importance of clinician–patient communication, and common diagnostic pitfalls, particularly in younger-onset or atypical presentations. She also highlights the growing role of digital tools, including wearable sensors and adaptive deep brain stimulation, in improving longitudinal monitoring and refining diagnostic accuracy in movement disorders.

Looking for more Movement disorder discussion? Check out the NeurologyLive® Movement disorder clinical focus page.

Episode Breakdown:

• 1:10 – Clinical features distinguishing tremor vs dyskinesia at bedside 
• 3:50 – Role of medication timing and levodopa response patterns
• 9:00 – Identifying patient-specific patterns and symptom awareness challenges 
• 13:20 – Neurology News Network 
• 16:10 – Common diagnostic pitfalls in Parkinson disease and movement disorders
• 17:50 – Role of wearables, biomarkers, and adaptive DBS in differentiation

• FDA Accepts Ultragenyx's Resubmitted BLA for MPS IIIA Gene Therapy UX111

• Elecsys NfL Test Receives European Approval for Monitoring Neuroinflammation in Relapsing-Remitting Multiple Sclerosis

• FDA Clears Cala kIQ Plus for Essential Tremor and Parkinson Disease Hand Tremor

Welcome to the NeurologyLive® Mind Moments® podcast. Tune in to hear leaders in neurology sound off on topics that impact your clinical practice.

In this Mind Moments episode, Sarah Hoffmann, MD, PhD, senior neurologist at Charité – University Medicine Berlin, provides clinical insight into the evolving and often challenging landscape of seronegative generalized myasthenia gravis (gMG). Drawing from both clinical experience and research, Hoffmann discusses how seronegative MG is defined in the absence of detectable antibodies and why it represents a heterogeneous and often underrecognized subgroup of patients. The conversation explores key diagnostic challenges, particularly in patients with limb-predominant symptoms, where differentiation from other neuromuscular or functional disorders can be difficult. Hoffmann also reviews current treatment approaches, noting that while standard therapies mirror antibody-positive MG, access to targeted treatments remains limited. Additional discussion focuses on the barriers to advancing clinical trials in this population, the need for reliable biomarkers to better stratify patients, and the importance of continually reassessing diagnosis in nonresponders to avoid both undertreatment and overtreatment.

Looking for more neuromuscular discussion? Check out the NeurologyLive® Neuromuscular clinical focus page.

Episode Breakdown:

• 1:15 – Defining seronegative MG and estimating prevalence within overall patient population 
• 2:15 – Diagnostic challenges and distinguishing seronegative MG from mimics and functional disorders 
• 5:35 – Role and limitations of antibody testing, electrophysiology, and pharmacologic response 
• 6:50 – Neurology News Network 
• 9:05 – Current treatment strategies and variability in access to targeted therapies 
• 11:55 – Barriers to clinical trials and need for improved patient stratification methods 
• 13:05 – Key unanswered questions including biomarkers and reassessing diagnosis in nonresponders 

• FDA Accepts Zilganersen New Drug Application for Priority Review in Alexander Disease

• FDA Grants Accelerated Approval to Tividenofusp Alfa for Neurologic Hunter Syndrome

• FDA Approves Higher Strength, More Effective Nusinersen Dose for Spinal Muscular Atrophy

Welcome to this special episode of the NeurologyLive® Mind Moments® podcast. Tune in to hear leaders in neurology sound off on topics that impact your clinical practice. For major FDA decisions in the field of neurology, we release short special episodes to offer a snapshot of the news, including the main takeaways for the clinical community, as well as highlights of the efficacy and safety profile of the agent in question.

In this episode, "Key Challenges Facing Neurology in the Year Ahead," Natalia Rost, MD, President of the American Academy of Neurology (AAN), Stroke Division Chief at Massachusetts General Hospital, and Professor of Neurology at Harvard Medical School, joins NeurologyLive to discuss the top clinical priorities shaping neurology in 2026.

Throughout the discussion, Rost outlines the most urgent unmet needs across neurology, including expanding equitable access to care, integrating preventive neurology into routine practice, strengthening the workforce, and closing persistent evidence gaps. She explains how the AAN Brain Health Initiative provides a practical framework for embedding brain health into everyday clinical encounters. The conversation also explores the growing role of biomarkers, imaging, and digital tools in care delivery, where innovation may be outpacing evidence, and how the Academy aims to guide ethical and evidence based implementation while addressing ongoing health equity gaps.

Episode Breakdown:

• 1:10 – Most urgent unmet clinical needs facing neurology in 2026
• 3:25 – Implementing brain health in everyday clinical practice
• 8:00 – Role of biomarkers, imaging, and digital tools in routine neurologic care
• 11:20 – AAN priorities for education, advocacy, and clinical guidance in 2026
• 14:25 – Major clinical gaps driving health inequities in neurologic care and outcomes

Welcome to the NeurologyLive® Mind Moments® podcast. Tune in to hear leaders in neurology sound off on topics that impact your clinical practice.

In this Mind Moments episode, Amaal Starling, MD, FAHS, FAAN, joins the podcast to provide clinical perspective on the INFUSE real world study evaluating IV eptinezumab in adults with migraine who previously found one or more CGRP preventive options ineffective, based on data presented at the 2026 Headache Cooperative of the Pacific Annual Conference. Starling, an associate professor of neurology at Mayo Clinic College of Medicine and a study author on INFUSE, discusses how clinicians should interpret the magnitude of benefit in a high burden population and why IV delivery, including rapid and consistent bioavailability, may help explain early and sustained response. The conversation also explores what the findings suggest for real world care and treatment sequencing, how migraine trials can better capture patient experience through outcomes like good days and PGIC, and what precision medicine research could look like next as the field pushes toward predictive modeling and individualized treatment selection.

Looking for more Headache & Migraine discussion? Check out the NeurologyLive® Headache & Migraine clinical focus page.

Episode Breakdown:

• 1:20 – Interpreting real world response after prior CGRP preventive failure
• 4:25 – Mechanistic reasons IV eptinezumab may drive early sustained benefit
• 6:25 – Clinical implications for earlier, more robust treatment sequencing
• 8:50 – Neurology News Network 
• 11:20 – Integrating good days and Patient Global Impression scales into migraine trial design
• 15:30 – Future studies needed to advance precision migraine care

• Fenebrutinib Achieves Primary End Point in Phase 3 Head-to-Head Trial vs Teriflunomide in Relapsing MS

• Praxis Submits NDAs for Ulixacaltamide in Essential Tremor and Relutrigine in SCN2A/SCN8A Developmental Epileptic Encephalopathies

• Efgartigimod Meets Primary End Point in Phase 3 ADAPT OCULUS Study of Ocular Myasthenia Gravis

Welcome to the NeurologyLive® Mind Moments® podcast. Tune in to hear leaders in neurology sound off on topics that impact your clinical practice.

In this special Mind Moments episode, Lauren Sansing, MD, MS, FAHA, FANA, Professor of Neurology at Yale School of Medicine, joins the podcast to provide a clinical breakdown of the 2026 International Stroke Conference and its implications for real-world stroke care. Sansing reflects on how this year’s meeting built on prior advances, highlighting expanded global collaboration, greater patient engagement, and a record number of clinical trials presented. The discussion explores which late-breaking studies may influence practice in the coming year, including data on secondary stroke prevention, adjunctive thrombolysis strategies, and evolving patient selection for thrombectomy in extended windows and large core infarcts. Sansing also reviews renewed momentum in neuroprotection research, key updates from the newly released acute ischemic stroke guidelines, emerging pediatric stroke data, and how the conference continues to shape the roadmap for 2027 and beyond.

Looking for more Stroke discussion? Check out the NeurologyLive® Stroke clinical focus page.

Episode Breakdown:

• 1:00 – Biggest moments and structural evolution of ISC 2026
• 3:15 – Presented practice-changing trial data impacting stroke care
• 7:05 – Thrombectomy strategy and extended window patient selection
• 10:40 – Renewed momentum in neuroprotection research
• 15:20 – Neurology News Network 
• 17:40 – Key updates from the new acute ischemic stroke guidelines
• 25:00 – A brief look-ahead to ISC 2027

• PTC Withdraws Ataluren Submission as Treatment for Nonsense Mutation Duchenne Muscular Dystrophy

• Microbiome-Targeted Agent PLL001 Passes Safety Check in Phase 1/2 Trial of ALS

• Rimegepant Displays Safety and Efficacy in Study of Adolescents With Migraine

Welcome to the NeurologyLive® Mind Moments® podcast. Tune in to hear leaders in neurology sound off on topics that impact your clinical practice.

In this Mind Moments episode, Jeff Chamberlain, PhD, joins the podcast during Duchenne Muscular Dystrophy Awareness Week to provide clinical and translational perspective on the evolving landscape of DMD biology and therapy. Chamberlain, professor at the University of Washington School of Medicine and Director of the Senator Paul D. Wellstone Muscular Dystrophy Cooperative Research Center in Seattle, reflects on aspects of Duchenne pathophysiology that may still be underappreciated, including evidence that disease processes begin earlier than once recognized and the growing importance of immunologic factors in shaping progression and therapeutic response. The conversation also explores how neuromuscular specialists should approach treatment timing and combination strategies as gene-targeted therapies expand, the evolving interpretation and limitations of biomarkers such as creatine kinase and dystrophin expression, and what emerging gene therapy platforms may signal for care heading into 2026 and beyond.

Looking for more Neuromuscular discussion? Check out the NeurologyLive® Neuromuscular clinical focus page.

Episode Breakdown:

• 1:15 – Underrecognized aspects of DMD pathophysiology, including early onset and immunologic drivers
• 4:50 – Treatment timing, sequencing, and the rationale for combination strategies
• 8:00 – Neurology News Minute
• 10:30 – Clinical trial and real-world implications of dystrophin and CK as biomarkers
• 16:20 – Anticipated gene therapy innovation and safety considerations heading into 2026

• Regenxbio's MPS II Gene Therapy RGX-121 Hit With CRL

• FDA Accepts New Drug Application for Orexin Agonist Oveporexton in Narcolepsy Type 1, Grants Priority Review

• FDA Expands Indication for Pitolisant to Treat Cataplexy in Pediatric Narcolepsy

Welcome to this special episode of the NeurologyLive® Mind Moments® podcast. Tune in to hear leaders in neurology sound off on topics that impact your clinical practice. For major FDA decisions in the field of neurology, we release short special episodes to offer a snapshot of the news, including the main takeaways for the clinical community, as well as highlights of the efficacy and safety profile of the agent in question.

In this special edition of Mind Moments, Shyam Prabhakaran, MD, MS, the James Nelson and Anna Louise Raymond Professor of Neurology and chair of the Department of Neurology at the University of Chicago Medicine, joined the show to discuss the recent updates to the American Heart Association/American Stroke Association's guideline for the early management of acute ischemic stroke.  Prabhakaran clarified the main takeaways for clinicians and touched on details around endovascular thrombectomy care in pediatrics as well as treatment within and outside of the golden window.

For NeurologyLive's coverage of ISC 2026, head here: International Stroke Conference (ISC)

Welcome to the NeurologyLive® Mind Moments® podcast. Tune in to hear leaders in neurology sound off on topics that impact your clinical practice.

In this Mind Moments episode, Benjamin Tolchin, MD, MS, FAAN, joins the podcast to provide clinical perspective on the recently published American Academy of Neurology (AAN) guidelines on functional seizures, drawing on his role as a contributing author to the recommendations. Tolchin, Director of the Center for Clinical Ethics at Yale New Haven Health and Associate Professor of Neurology at Yale School of Medicine, discusses what prompted the development of the first AAN guideline in this space and how the evidence base evolved to support formal recommendations. The conversation explores key considerations around diagnosing functional seizures, including history, semiology, EEG use, and the growing role of video documentation. Tolchin also addresses how clinicians should approach psychiatric comorbidities and co-occurring epilepsy, the evidence supporting psychological interventions, why pharmacologic therapies are not recommended for functional seizures themselves, and where major gaps remain in research to advance care in the years ahead.

Looking for more Epilepsy discussion? Check out the NeurologyLive® Epilepsy clinical focus page.

Episode Breakdown:

• 1:10 – Why growing evidence prompted the first AAN guideline on functional seizures
• 3:20 – Diagnostic priorities including history, semiology, EEG, and video documentation
• 6:15 – Assessing psychiatric comorbidities and co-occurring epilepsy in functional seizures
• 9:15 – Neurology News Minute
• 11:30 – Evidence supporting psychotherapy for functional seizures
• 14:50 – Pharmacological evidence and use of antiseizure medications for functional seizures
• 18:35 – Barriers to advancing clinical trials in functional seizures
• 22:05 – Research priorities to refine treatment and long-term outcomes

• FDA Approves Subcutaneous Copper Histidinate as First Treatment for Pediatric Menkes Disease

• sBLA Acceptance Positions Efgartigimod as Potential First Therapy for Seronegative Myasthenia Gravis

• High-Dose Nusinersen Gains European Commission Approval for Spinal Muscular Atrophy

Welcome to the NeurologyLive® Mind Moments® podcast. Tune in to hear leaders in neurology sound off on topics that impact your clinical practice.

In this episode, "Bexicaserin, the PACIFIC Trial, and Treating Developmental Epileptic Encephalopathies," Johannes Streffer, MD, PhD, discusses phase 1/2 findings from the PACIFIC trial evaluating bexicaserin in developmental epileptic encephalopathies, presented at the American Epilepsy Society 2025 Annual Meeting. Streffer, senior vice president of clinical development at Lundbeck, outlines the scientific and clinical rationale for studying DEEs as a unified population, emphasizing the unmet need and complexity of trial design in this highly vulnerable group. He reviews key efficacy outcomes, including sustained reductions in countable motor seizures and strong patient retention through long-term open-label extension and expanded access follow-up. The discussion also explores safety and tolerability considerations in patients receiving multiple concomitant antiseizure medications, the highly selective mechanism of action of bexicaserin, and how Lundbeck’s broader strategy in rare neurological disorders aims to de-risk development early while addressing populations with limited therapeutic options.

Looking for more Epilepsy discussion? Check out the NeurologyLive® Epilepsy clinical focus page.

Episode Breakdown:

• 1:05 – Rationale for studying developmental epileptic encephalopathies as a unified group
• 3:05 – Challenges of trial design and retention in vulnerable pediatric DEE populations
• 5:25 – Key PACIFIC efficacy findings and long-term open-label extension results
• 7:05 – Neurology News Minute
• 9:15 – Safety, tolerability, and drug-drug interaction considerations for bexicaserin
• 11:20 – Lundbeck's strategy across rare and severe neurological disorders

• Remyelinating Agent PIPE-307 Falls Short in Phase 2 Trial of Relapsing Multiple Sclerosis

• Semaglutide Linked to Improved Neurological Outcomes in Large Vessel Occlusion Without IV Thrombolysis

• FDA Approves Generic Glatiramer Acetate Injection for Multiple Sclerosis Treatment

• 1:05 – Advances and remaining gaps in the clinical understanding of narcolepsy
• 2:30 – How narcolepsy care and research meaningfully evolved throughout 2025
• 4:50 – Sleep disorders, neurodegeneration, and what clinicians should watch for
• 6:50 – Neurology News Minute
• 8:50 – Persistent myths that delay diagnosis and affect clinical decision-making
• 12:30 – How lived experience shapes holistic, patient-centered narcolepsy care

• FDA Approves Inebilizumab for AChR- and MuSK-Positive Generalized Myasthenia Gravis

• FDA Clears Pivotal Phase 3 PREVAiLS Study of Pridopidine in Early, Rapidly Progressive ALS

• Tolebrutinib Falls Short in Phase 3 PERSEUS Study, Forcing Decision to Redact Regulatory Submission

• 1:10 – How mood and behavior symptoms shape Parkinson disease quality of life
• 5:30 – How conversations about mental health in Parkinson disease have evolved
• 9:25 – Screening tools and practical assessment strategies for mood and anxiety
• 13:40 – Neurology News Minute
• 15:50 – Foundation and community initiatives supporting mood and behavior care
• 19:50 – Remaining gaps, cultural barriers, and mental health parity challenges

• CTAD Presentation Lays Insights Into Disappointing Phase 3 EVOKE Trial of GLP-1 Semaglutide in Alzheimer Disease

• Gene Therapy ETX101 Demonstrates Significant Effects on Seizure Reduction, Neurodevelopmental Outcomes in POLARIS Phase 1/2 Program

• FDA Accepts NDA for Low-Sodium Oxybate TRN-257 in Narcolepsy and Idiopathic Hypersomnia

• 1:05 – Origins of the study, need to pursue more standardized care in IESS
• 4:40 – Reasons behind treatment variability after first and second-line options
• 8:00 – What research is needed to guide sequencing and standardize care
• 12:05 – Neurology News Minute
• 14:30 – What makes IESS studies difficult and how infrastructure can improve
• 18:50 – Lesser-discussed gaps, including ketogenic diet and surgical evaluation

• Positive Phase 3 OCEANIC-STROKE Data Position Asundexian for Upcoming FDA Submission

• FDA Approves New Intrathecal Administration Route for Spinal Muscular Atrophy Gene Therapy

• GLP-1 Semaglutide Fails to Outperform Placebo in Phase 3 EVOKE Trial of Alzheimer Disease

• 1:05 – Reflections on meeting highlights and NEALS rebranding into a global network
• 5:00 – Notable NEALS-affiliated trials and promising new mechanisms in ALS care
• 12:45 – Combination therapy strategies and future approaches in ALS research
• 15:20 – Neurology News Minute
• 18:00 – Expanding clinical trial access for rare and genetic ALS subtypes
• 22:10 – Building momentum and expectations for the 2026 NEALS Annual Meeting

• FDA Approves Doxecitine and Doxribtimine Combination Therapy as First Treatment for Thymidine Kinase 2 Deficiency

• Supplemental New Drug Application Submitted for AXS-05 as Treatment for Alzheimer Disease Agitation

• BTK Inhibitor Fenebrutinib Meets Primary End Points in Phase 3 Trials for Both Relapsing and Primary Progressive MS 

• 1:05 – Understanding the purpose and mission behind new blood-based biomarker guidelines
• 2:05 – Key recommendations and defining triage vs confirmatory blood-based biomarker use
• 3:15 – Clinical precautions and where blood-based biomarkers are appropriate today
• 5:30 – Neurology News Minute
• 7:45 – Educating clinicians on implementing BBMs in specialty care
• 10:15 – Research priorities to strengthen evidence and ensure equity

• FDA Accepts New Drug Application for Tau PET Imaging Agent MK-6240 in Alzheimer Disease

• B-Cell Modulator Obexelimab Shows Pronounced Relapse Reduction in Phase 2 MoonStone Trial

• Subcutaneous Efgartigimod Shows Efficacy in Phase 2 ALKIVIA, Phase 3 ADAPT SERON Trials

• 0:55 – How epilepsy care has evolved and where progress has been made
• 5:30 – Whether first-line therapy choices for epilepsy should be re-evaluated
• 8:35 – Why gene therapy progress has been slower than expected in epilepsy
• 12:05 – Neurology News Minute
• 14:10 – What areas of epilepsy research deserve greater attention and funding
• 17:10 – How GLP/GIP agents could intersect with neurological and epilepsy care
• 20:00 – How clinicians can better address neurodevelopmental challenges in patients with epilepsy

• Neflamapimod Advances to Phase 3 Trial in Dementia With Lewy Bodies After Positive RewinD-LB Results

• FDA Delays Review Deadline for Hunter Syndrome Agent Tividenofusp Alfa

• FDA Clears Roche’s Elecsys pTau181 Test for Ruling Out Alzheimer-Related related Amyloid Pathology

• 1:00 – Overall impressions of ECTRIMS 2025, highlighting diagnostic updates, precision medicine, and late-breaking trial results
• 4:10 – Expanding focus on individualized care, especially interval-adjusted dosing strategies for B-cell therapies
• 7:50 – Neurology News Minute
• 9:50 – Insights on emerging therapeutic approaches including BTK inhibitors, CAR-T therapies, and remyelination strategies
• 14:35 – Growing attention toward NMOSD, MOGAD, and other autoimmune conditions within neuroimmunology discussions

• EMA Approves Semaglutide as First GLP-1 RA for Cardiovascular, Stroke-Related Benefits

• Del-Zota Reverses Duchenne Disease Progression in 1-Year Trial Update

• MDA and PPMD Release Consensus Guidelines for Safe and Equitable Use of Gene Therapy in Duchenne

• 1:00 – Consequences of delayed or unavailable levodopa treatment for patients worldwide
• 2:40 – How universal levodopa access could change care in low-resource settings
• 5:15 – Lessons from global HIV drug distribution for equitable levodopa delivery
• 7:00 – Neurology News Network
• 8:35 – Key pillars of The Parkinson Plan and rethinking Parkinson’s care models

• EMA Approves Semaglutide as First GLP-1 RA for Cardiovascular, Stroke-Related Benefits

• Del-Zota Reverses Duchenne Disease Progression in 1-Year Trial Update

• MDA and PPMD Release Consensus Guidelines for Safe and Equitable Use of Gene Therapy in Duchenne

For more of NeurologyLive's coverage of fremanezumab's expanded indication in pediatric migraine, head here: FDA Approves Fremanezumab as First Anti-CGRP Preventive Therapy for Pediatric Episodic Migraine

• 1:10 – Initial reaction to fremanezumab approval and significant for pediatric migraine care
• 6:05 – Major clinical insights and takeaways from phase 3 SPACE trial
• 10:20 – Challenges in pediatric migraine trials and addressing high placebo responses
• 15:10 – Future directions in migraine therapy, including PACAP-targeting drugs and novel approaches

• 1:00 – Why consensus guidelines were needed for gene therapy in DMD
• 2:10 – Top-line clinical considerations from the published recommendations
• 4:30 – Protocols for monitoring and managing adverse events, especially liver toxicity
• 6:30 – Neurology News Network
• 8:30 – Addressing health equity, language access, and financial barriers in gene therapy care
• 12:00 – How these recommendations may shape the future of DMD treatment
  
  

• Efgartigimod Aims to Become First Therapy for Seronegative Generalized Myasthenia Gravis Following Positive Phase 3 Data

• FDA Approves Lecanemab Autoinjector, Marking First At-Home Treatment for Alzheimer Disease

• Eisai Submits sBLA for Weekly Subcutaneous Lecanemab as Starting Dose

• 1:00 – Global survey findings on epilepsy transition of care
• 2:10 – Key considerations for students with epilepsy entering college
• 3:50 – Ensuring continuity of care during transition into adulthood
• 5:45 – Neurology News Minute
• 7:30 – Common challenges and strategies to overcome them
• 9:30 – Final thoughts on back-to-school care and global survey insights

• Ianalumab Meets Primary End Points in Phase 3 NEPTUNUS Trials of Sjögren’s Disease

• Praxis’ Vormatrigine Shows Significant Ability to Reduce Seizure Incidence in Phase 2 RADIANT Study

• FDA Denies Approval for Friedreich Ataxia Agent Vatiquinone, Citing More Efficacy Needed

• 1:00 – How movement disorder diagnosis is approached through history, physical exam, and phenomenology
• 4:05 – What makes certain movement disorder cases complex and how diagnostics like genetics and imaging are used
• 6:20 – Neurology News Minute
• 8:45 – How nonmotor symptoms in Parkinson’s (fatigue, constipation, sleep) are managed with lifestyle strategies
• 12:30 – Approaching therapeutic communication and expectation-setting with patients and families

• Eisai Showcases Promising 4-Year Data for Alzheimer Therapy Lecanemab at AAIC 2025

• IHL-42X to Enter Phase 3 Trials for Obstructive Sleep Apnea Following Positive Phase 2 Data

• FDA Approves Fremanezumab as First Anti-CGRP Preventive Therapy for Pediatric Episodic Migraine

• 1:00 – Overview of the new donanemab dosing regimen and its goal to reduce ARIA risk
• 2:30 – Rationale behind the four different dosing strategies tested in Trailblazer-ALZ-6
• 6:00 – What clinicians should know about patient risk and genotype testing
• 8:00 – Neurology News Minute
• 10:10 – Clinical implications of the updated label, including risk-benefit conversations
• 13:45 – Surprising results from the trial, particularly for APOE4 homozygous patients
  
  

• Orexin-Targeting Agent TAK-861 Meets All End Points in Phase 3 FirstLight and RadiantLight Studies

• FDA Shuts Down Sarepta's Distribution of Gene Therapy Elevidys Following Patient Deaths

• AD109 Meets End Points in Phase 3 LunAIRo Trial, Eyeing FDA Submission for Obstructive Sleep Apnea

For more of NeurologyLive's coverage of STS101 and CT-132 for migraine, head here: FDA Approves STS101 Nasal Powder as New Treatment for Acute Migraine

FDA Approves CT-132 as First Digital Therapeutic for Preventive Treatment of Episodic Migraine

• 1:10 – Overview of DHE, patient suitability, and STS101’s place in treatment
• 6:05 – Efficacy and safety data from the ASCEND and SUMMIT trials for STS101
• 10:20 – The expanding migraine toolbox and need for clinician education
• 15:10 – CT-132’s first-in-class status and clinical trial data
• 16:25 – Clinical use of CT-132 as an add-on preventive
• 19:30 – The knowledge gap on digital therapeutics and educating the neurology community
• 23:00 – Future directions and hopes for expanded CT-132 research

• 1:00 – Overview of the glymphatic system and its relevance in stroke care
• 2:55 – Evidence linking sleep quality and glymphatic activity in stroke prevention and recovery
• 7:40 – Neurology News Minute
• 10:05 – Potential interventions: pharmacologic and nonpharmacologic approaches to enhance glymphatic function
• 13:10 – Raising clinical awareness of sleep’s role in stroke and neurologic disease management
  
  

• FDA Grants Priority Review, Sets PDUFA Date for Hunter Syndrome Treatment Tividenofusp Alfa

• FDA Approves Updated Label for Alzheimer Therapy Donanemab to Lower ARIA-E Risk

• Exablate Neuro Gains FDA Approval for Staged Bilateral Focused Ultrasound in Advanced Parkinson Disease

• 1:00 – Key differences in phenotype and diagnosis between Dravet syndrome and LGS
• 3:00– The evolution of genetic testing and how it’s improved Dravet diagnosis and outcomes
• 5:25 – Opportunities and limitations in scaling genetic testing more broadly
• 6:35 – Neurology News Minute
• 8:45 – Research pipelines: disease-modifying therapies, n-of-1 trials, and future directions
• 10:20 – Innovations in clinical trial design and the need for better seizure monitoring and biomarkers

• European Commission Approves Efgartigimod Subcutaneous Injection for Forms of CIDP

• FDA Greenlights Expanded Indication for Vizamyl in Alzheimer Disease Diagnosis

• Grace Therapeutics Submits NDA for GTX-104 to Treat Aneurysmal Subarachnoid Hemorrhage

• 1:00 – Mechanism and rationale behind bemdaneprocel as a dopaminergic cell therapy
• 3:00– Key design considerations for conducting a registrational phase 3 cell therapy trial
• 5:25 – Trial structure, eligibility criteria, and ongoing patient recruitment
• 6:35 – Neurology News Minute
• 8:45 – Significance of reaching phase 3 with a cell therapy in Parkinson disease
• 10:20 – Future role of cell therapy within the Parkinson disease treatment landscape
• 12:10 – Unique aspects of the exPDite-2 trial and what sets it apart from earlier efforts

• BTK Inhibitor Fenebrutinib Demonstrates Long-Term Suppression of MS Activity in Open-Label Extension

• REGENXBIO Reports Positive Phase 1/2 Data for Higher Dose of RGX-202 in Duchenne Muscular Dystrophy

• NewAmsterdam Pharma Reports Positive Topline Data of Alzheimer Agent Obicetrapib from Phase 3 BROADWAY Trial

• 1:00 – Significance of World MS Day and the importance of global MS awareness
• 2:05– Commonly recognized vs overlooked MS symptoms in patient care
• 3:10 – Transitioning to updated MS diagnostic criteria and the need for global provider education
• 4:15 – Neurology News Minute
• 6:30 – Research priorities: progressive MS, symptom management, and remyelination strategies
• 7:35 – The role of lifestyle, risk factor control, and holistic care in MS management
• 8:50 – Communicating MS diagnosis with empathy, support, and resource guidance

• FDA Approves First Autoinjector Form of DHE for Acute Migraine and Cluster Headache

• FDA Clears Lumipulse Plasma Ratio as First Blood Test for Diagnosing Alzheimer Disease

• Once-Daily Oral Pill for Obstructive Sleep Apnea Shows Promising Phase 3 Results, Paving Way for FDA Submission

• 1:00 – Study goals and the shift from genotype-to-phenotype toward phenotype-to-genotype mapping
• 2:40– Overview of the 4 main phenotypic clusters identified in the TSC population
• 8:05 – Genetic domain associations and their impact on clinical monitoring and treatment
• 11:50 – Neurology News Minute
• 14:45 – Understanding overlap between clusters and avoiding overprediction in clinical settings
• 17:00 – Implications for future surveillance strategies and precision candidate selection in TSC trials

• FDA AdComm Plans to Review Investigational Cell Therapy Deramiocel for DMD Cardiomyopathy

• Gene Therapy AAV-GAD Gains Regenerative Medicine Advanced Therapy Designation as Potential Parkinson Treatment

• Microbiome-Targeting Therapy MaaT033 Continues to Show Promise in Final Phase 1 Readout

• 1:00 – Overview of the ABC-DS initiative and the growing inclusion of Down syndrome in Alzheimer research
• 2:00– Current state of clinical trials and progress in therapeutic development for this population
• 3:30 – Evolution of outcome assessments tailored for individuals with Down syndrome
• 5:40 – Challenges in distinguishing Down syndrome traits from signs of early dementia
• 7:40 – Clinician educations needs and improving access to specialized care
• 9:00 – Neurology News Minute
• 11:00 – Eligibility and considerations for anti-amyloid therapies in Down syndrome
• 13:35 – Research gaps, co-occurring conditions, and the importance of reaching underserved populations
• 16:40 – Top priorities from patients and families: independence, inclusion, and respect in care settings

• GENERATION HD2 Trial of Huntington Agent Tominersen Amended to Include Only Higher Dose

• FDA Grants Authorization to Epiminder’s Implantable Continuous EEG Monitor for Epilepsy Treatment

• FDA Approves FcRn Blocker Nipocalimab for Broad Forms of Generalized Myasthenia Gravis

• 1:00 – Key sleep topics discussed at AAN 2025 and the growing interest in hypersomnia
• 5:45 – Development and purpose of the SLEEP mobile app by Cleveland Clinic
• 10:35 – Findings on obstructive sleep apnea prevalence in adults with epilepsy
• 15:05 – Neurology News Minute
• 17:10 – The need for sleep disorder screening in epilepsy clinical trials
• 19:45 – Exploratory findings on SSRI use and respiratory patterns in patients with epilepsy

• FDA Approves Pre-Filled Syringe Administration for FcRn Modulator Efgartigimod

• FDA Approves CT-132 as First Digital Therapeutic for Preventive Treatment of Episodic Migraine

• FDA Expands Diazepam Nasal Spray Indication to Treat Ages 2 to 5

• 1:00 – Overview of the national needs assessment survey 
• 3:45 – Importance of lesion localization and neuroradiology for NP postgraduate training
• 6:05 – The role of neuropathology in neurology education for nurse practitioners
• 8:05 – Challenges with clinical rotation preceptors and the shortage in neurology
• 9:40 – Neurology News Minute
• 12:10 – The role of NP programs in providing clinical experience
• 14:55 – Variability and lack of standardization in NP neurology education
• 18:05 – Evolving duties and responsibilities of NPs over the coming years
• 19:35 – Closing thoughts, acknowledging the contributions of Kate Sweeter, NP, and the value of NPs in neurology

• FDA Accepts Regulatory Submission for BTK Inhibitor Tolebrutinib for Non-Relapsing Secondary Progressive MS

• FDA Approves Diazoxide Choline Extended-Release Tablets for Hyperphagia in Prader-Willi Syndrome

• Genentech Reports High-Dose Ocrelizumab Fails to Show Additional Benefit in Relapsing MS

For more of NeurologyLive's coverage of SPN-830 for Parkinson disease, head here: FDA Approves Apomorphine Infusion Device SPN-830 as New Parkinson Treatment

• 1:05 – Significance of SPN-830's approval and impact on PD community
• 3:10 – Considerations for treatment selection with SPN-830, conversations with families
• 5:50 – Neurology News Minute
• 7:50 – TOLEDO study, supportive efficacy and safety data for SPN-830
• 11:45 – Expanding PD treatment options and overviewing recent progress in research

• FDA Approves Vutrisiran for ATTR-CM, Expanding Indication in Amyloidosis

• FDA Accepts Regulatory Submission for BTK Inhibitor Tolebrutinib for Non-Relapsing Secondary Progressive MS

• Simufilam Fails to Meet Key End Points in Phase 3 Alzheimer Disease Trial

• 1:05 – Funding priorities for neuromuscular research and NIH support
• 1:55 – Role of gene editing, assistive devices, and AI in care
• 4:50 – Collaboration and togetherness of the neuromuscular community
• 6:35 – Considerations as new therapeutics emerge for neuromuscular disorders
• 8:05 – Funding solutions for equitable care

For more of NeurologyLive's coverage of sodium oxybate's (Lumryz) expanded indication, head here: FDA Approves Tenecteplase for Acute Ischemic Stroke

• 1:40 – Immediate reaction and significance of tenecteplase approval
• 5:30 – Safety considerations and administration when prescribing tenecteplase
• 10:20 – Supportive efficacy and safety, phase 3 AcT trial, and other supplementary studies
• 14:50 – Advancing precision medicine, treatment personalization with new approval

• 1:10 – Significance of Purple Day, raising awareness on epilepsy stigma
• 5:00 – Advances in epilepsy care, including availability of more anti-seizure medications and genetic insights
• 8:45 – Neurology News Minute
• 11:10 – Challenges in elderly epilepsy care and the need for more standardized transition models from pediatrics to adulthood
• 15:20 – Optimizing epilepsy monitoring units and dealing with staff and equipment shortages
• 20:50 – Closing thoughts

• FDA Approves Medtronic’s Adaptive Deep Brain Stimulation for Parkinson Disease

• FDA Approves Tenecteplase for Acute Ischemic Stroke

• FDA Approves Expanded Use of Eculizumab for Pediatric Myasthenia Gravis

• 1:00 – Challenges and importance of social connections
• 5:45 – Building a thriving community and research impact
• 7:30 – Insights from patient surveys on social support
• 10:30 – Neurology News Minute
• 12:25 – Recommendations for clinicians on social support

• FDA Approves Mirdametinib for NF1-Associated Plexiform Neurofibromas in Adults and Children

• FDA Approves Tablet Formulation of Risdiplam for Spinal Muscular Atrophy

• Solid Reports Positive Data for SGT-003 Gene Therapy in Phase 1/2 Trial of Duchenne

• 1:10 – Reasons behind "Making Connections" theme 
• 2:50 – Overviewing key unique sessions and forums from the meeting
• 5:10 – Aligning curriculum with 2024 MS McDonald Criteria
• 7:00 – Neurology News Minute
• 9:00 – Drug development topics from ACTRIMS 2025
• 12:20 – Differences between ACTRIMS 2025 vs ACTRIMS 2024

• FDA Approves Axsome Therapeutics’ AXS-07 for Migraine Treatment

• FDA Approves Vertex Pharmaceuticals' Suzetrigine for Acute Pain Management

• FDA Approves Apomorphine Infusion Device SPN-830 as New Parkinson Treatment

• 1:05 – Overview of the published guidance and reasons behind the paper 
• 5:15 – Patient selection for neuromodulation and tailoring treatments by patient and preference
• 8:25 – Overcoming complications with neuromodulation devices 
• 11:25 – Multidisciplinary team necessary for successful implementation of neuromodulation
• 13:15 – Neurology News Minute
• 15:15 – Initiation and titration strategies for vagus nerve stimulation, deep brain stimulation, and resective surgery
• 18:30 – Next steps in research and expanding neuromodulation for patients with LGS
• 21:10 – Finding creative trial designs to test neuromodulation devices, combination approaches

• FDA Accepts BLA for Subcutaneous Autoinjector Formulation of Lecanemab

• Cell Therapy Bemdaneprocel Advances to Phases 3 Registrational Trial in Parkinson Disease

• Real-World Study Highlights Positive Treatment Benefits of Tofersen on ALS Disease Progression, Function

• 1:05 – Overviewing mechanistic function of SAAmplify-aSYN biomarker test, its purpose, and how it came about
• 7:50 – Results from the published study; ways the fluorescence-based amplification method could distinguish MSA from PD and Lewy body dementia
• 16:25 – Neurology News Minute
• 18:30 – Therapeutic feasibility of the assay in clinical settings and the next steps in validation

• Axsome to Submit NDA for AXS-05 in Alzheimer Agitation Following Positive Phase 3 Trials

• FDA Clears IND for Trial Assessing Gene Therapy SGT-212 in Friedreich Ataxia

• FDA Grants Fast Track Designation to Anti-Tau Therapy Posdinemab

• Daniel Ontaneda, MD, PhD, a staff member of the Cleveland Clinic Mellen Center for Multiple Sclerosis, who gave an overview on the new 2024 McDonald criteria to diagnose multiple sclerosis (MS), which was presented at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). 
  • Check out the full episode here: https://www.neurologylive.com/view/episode-125-understanding-major-changes-new-mcdonald-criteria-multiple-sclerosis
• Ian Kremer, executive director of the leaders Engaged on Alzheimer's Disease (LEAD) coalition, on the changing and exciting advances in Alzheimer disease therapeutics, as well as the discontinuation of aducanumab, the first approved antiamyloid therapy. 
  • Check out the full episode here: https://www.neurologylive.com/view/episode-113-lessons-learned-alzheimer-drug-development
• Andy Berkowski, MD, PhD, vice chair of the American Academy of Sleep Medicine's Practice Guidelines Task Force, discusses the newly revised guidelines for restless legs syndrome, including the latest updates in literature and changes to clinical care. 
  • Check out the full episode here: https://www.neurologylive.com/view/episode-129-implications-2024-aasm-guidelines-restless-legs-syndrome
• Sameea Husain-Wilson, DO, a movement disorder specialist at the Marcus Neuroscience Institute of Baptist Health, provided clinical perspective on the use of the Syn-One diagnostic test for patients with Parkinson disease.
  • Check out the full episode here: https://www.neurologylive.com/view/episode-119-utilizing-the-syn-one-test-to-diagnose-parkinson-disease
• Jonathan Parker, MD, PhD, an assistant professor of neurosurgery at Mayo Clinic Arizona, spoke at the 2024 American Epilepsy Society Annual Meeting on cell therapy approaches for epilepsy, the challenges the clinical community faces, and the outlook for the future. 
  • Check out the full episode here: https://www.neurologylive.com/view/episode-130-promise-behind-cell-therapy-approaches-epilepsy
• Lawrence Robinson, MD, a senior scientist at Sunnybrook Research Institute, gives insight on educating the next generation of neuromuscular and electrodiagnostic (EDX) practitioners, and the major differences in how this generation of medical students learn relative to previous ones. 
  • Check out the full episode here: https://www.neurologylive.com/view/episode-127-adapting-neuromuscular-electrodiagnostic-medicine-education-modern-learners

• 1:05 – Ontaneda on the incorporation of new biomarkers into the 2024 McDonald Criteria for multiple sclerosis.
• 7:35 – Kremer on the lessons learned from drug development, including antiamyloid treatments, and initial reaction to the discontinuation of aducanumab for AD. 
• 10:30 – Berkowski on the outlook of treating and preventing restless legs syndrome going forward using the newly updated American Academy of Sleep Medicine treatment guidelines. 
• 13:10 – Husain-Wilson on the function of the Syn-One test for Parkinson disease, its applicability, and how it may distinguish patients with PD from other synucleinopathies.
• 18:40 – Parker on the promise and thought process behind stem cell approaches for drug-resistant epilepsy, including the different types of cell methods being tested. 
• 21:45 – Robinson on the distinct differences in learning styles based on generation, the importance of adaptive teaching, and the new approaches educators in neuromuscular and electrodiagnostic medicine can take. 

• 1:00 – Idea behind cell therapy to treat epilepsy
• 4:05 – Current state of stem cell therapies for neurological disorders, focusing on Parkinson disease, stroke, and epilepsy
• 8:05 – NTE001 study of NRTX-1001, an investigational human embryonic stem cell product
• 11:45 – Neurology News Minute
• 13:50 – Unanswered questions and safety concerns with cell therapies; challenges with clinical trial design and the need for more innovative trials
• 17:35 – Misconceptions or gaps in understanding about cell therapies for epilepsy
• 20:05 – Unique challenges and potential of stem cell therapies for epilepsy, particularly in younger patients; patient motivation and hope

• Anavex Submits Marketing Authorization Application for Blarcamesine in Alzheimer Disease in the EU

• Testing Begins for RELIEV-CM2 Study of ShiraTronics Neuromodulation Device in Chronic Migraine

• STK-001 Gains FDA Breakthrough Designation as Potential Disease-Modifying Treatment for Dravet Syndrome

• 1:00 – Reasons behind new guidelines, progress in clinical research
• 2:50 – Overview of the greatest changes to the guidelines and what treating physicians should key in on
• 11:25 – Neurology News Minute
• 13:40 – How the guidelines address management based on age, sex, and RLS subtype
• 16:30 – Challenges when drafting the guidelines and the unanswered questions that remain
• 20:10 – A promising future for treating, managing, and preventing RLS

• Neurogene Reports Serious Adverse Event in Phase 1/2 Rett Study of Gene Therapy NGN-401

• Huntington Agent SAGE-718 to be Discontinued Following Disappointing Phase 2 DIMENSION Trial Results

• Alzheimer Agent Simufilam Fails to Meet Primary End Point in Phase 3 Study

• 1:00 – Background on various machine learning approaches for epilepsy research
• 3:20 – Study details, findings, and notable takeaways
• 8:20 – Neurology News Minute
• 10:20 – Novelty in using scalp EEG and its global application
• 15:30 – Team personnel needed for proper implementation of machine learning techniques in epilepsy surgery

• FDA Accepts Resubmitted NDA for Ataluren in Nonsense Duchenne Muscular Dystrophy

• FDA Places Clinical Hold on Epilepsy Agent RAP-219 for Diabetic Peripheral Neuropathic Pain

• First-Ever CRISPR/Cas13-RNA Editing Therapy to be Tested in Phase 1 Study of Age-Related Macular Degeneration

• 1:05 – Overviewing and background on AANEM presentation
• 3:15 – Challenges with educating next generation of neuromuscular and EDX practitioners
• 4:40 – Areas of opportunity and growth for these next generation learners
• 5:50 – Neurology News Minute
• 8:00 – Novelty and advantages of flipped classroom approaches to teaching
• 10:10 – Future expected changes to neuromuscular care
• 11:55 – Final thoughts on care on NM and EDX education

• Phase 3 ENSURE Program of Vidofludimus Calcium Continues Following Positive Futility Analysis

• Gene Therapy FLT201 Shows Promise in Early-Stage Study of Gaucher Disease

• Risk of ARIA-E in Donanemab Attenuated Through New Enhanced Titration Method of Delivery

For more of NeurologyLive's coverage of sodium oxybate's (Lumryz) expanded indication, head here: FDA Approves Avadel's Sodium Oxybate for Cataplexy or Excessive Daytime Sleepiness in Pedatric Narcolepsy

• 2:10 – Immediate reaction and significance 
• 4:10 – Considerations and caution with prescribing sodium oxybate
• 8:20 – Closing remarks and the need to utilize highly effective treatments for narcolepsy

• 1:10 – Overviewing the conduct of the phase 1/2 studies
• 3:00 – Notable findings from data presented at MDS
• 4:30 – Mechanism of action behind ATH434
• 8:20 – Neurology News Minute
• 10:20 – Next steps in ATH434's development
• 11:15 – Current unmet needs for patients with MSA

• FDA Removes Partial Hold for Myotonic Dystrophy Agent AOC 1001

• FDA Approves Avadel's Sodium Oxybate for Cataplexy or Excessive Daytime Sleepiness in Pedatric Narcolepsy

• FDA Approves AbbVie’s 24-Hour Foscarbidopa/Foslevodopa Pump for Advanced Parkinson Disease Treatment

• 1:10 – Focus and direction of new diagnostic criteria
• 3:00 – Overviewing specific changes to McDonald criteria
• 10:50 – Approach to diagnosing pre-MS; treating radiologically isolated syndrome earlier
• 12:55 – Neurology News Minute
• 15:10 – Incorporation of new biomarkers, central vein sign, paramagnetic rim lesions, OCT
• 21:45 – Unanswered questions/challenges left out of the diagnostic criteria

• Potential Regulatory Submission for Inebilizumab in Myasthenia Gravis Following Positive Phase 3 MINT Data

• Parkinson Agent Tavapadon Meets Primary and Secondary End Points as Monotherapy in Phase 3 TEMPO-1 Trial

• Sage Therapeutics and Biogen Officially Announce Ending of SAGE-324 Program in Essential Tremor

• 1:15 – Overview of CANYON study and extension phase 
• 3:50 – Mechanism of action of EDG-5506
• 6:30 – How previous trial experiences shaped CANYON 
• 10:10 – Neurology News Minute
• 11:50 – Ongoing challenges with treating and testing drugs for Becker
• 15:25 – Safety profile of EDG-5506
• 16:45 – Ways to tackle cardiac issues in Becker

• Digital Therapeutic CT-132 Meets Primary End Point in Phase 3 Study of Preventive Migraine

• FDA Supports Alpha-Synuclein Seed Amplification Assay Biomarker for Clinical Trials in Parkinson Disease

• FDA Approves Subcutaneous Formulation of Ocrelizumab for Relapsing and Progressive Multiple Sclerosis

• 1:10 – Mission and goals of Epilepsy Summit 
• 3:05 – Overviewing sessions and educational attainment
• 4:55 – Changes to epilepsy surgery, advances over the years
• 9:15 – Neurology News Minute
• 11:50 – Learning curve for understanding new epilepsy surgery tactics
• 13:50 – Closing thoughts on the upcoming meeting
• 15:50 – Potential benefits and challenges to gene therapy for epilepsy

• EMA Accepts Marketing Authorization Application for Huntington Disease Agent Pridopidine

• BTK Inhibitor Tolebrutinib Slows Disability Progression in Phase 3 HERCULES Study of Non-Relapsing Secondary Progressive MS

• FDA Accepts Resubmitted New Drug Application for Migraine Treatment AXS-07

• 1:15 – Mechanism of action of mivelsiran and how it can be potentially beneficial in AD
• 4:15 – Growing knowledge of RNA therapeutics and their impact on neurologic conditions
• 7:00 – Neurology News Minute
• 10:10 – Phase 1 study data, including efficacy, safety, biomarker, and pharmacokinetic results
• 19:20 – How mivelsiran fits with other approved therapies for AD; future goals and directions of the drug

• FDA Clears Indapta Therapeutics’ IND for Cell Therapy IDP-023 in Progressive Multiple Sclerosis

• Muscle-Targeting Therapy Apitegromab Effective in Spinal Muscular Atrophy Over 4 Year Period

• FDA Approves Medtronic’s Deep Brain Stimulation Technology for Asleep Capabilities

• 1:15 – Reasons behind the XYLO study and links between high sodium intake and cardiovascular risk
• 4:45 – Patient demographics; inclusion and exclusion criterias
• 6:40 – Neurology News Minute
• 9:25 – Overview of XYLO and determining what a successful study looks like
• 15:30 – Improved understanding of the benefits of low-sodium oxybate

• EU Regulatory Review Adopts Negative Opinion of Lecanemab as Treatment for Alzheimer Disease

• GLP-1 Agonist Liraglutide Shows Protective Effects on Alzheimer Disease in Phase 2 Trial

• FDA Approves Carbidopa/Levodopa ER Capsules Formulation IPX203 for Parkinson Disease

• 1:05 – Significance of ublituximab awarded national contract as preferred anti-CD20 for relapsing MS
• 3:30 – Advantages and differences of ublituximab vs approved therapies for MS
• 11:40 – Neurology News Minute
• 14:30 – Growing knowledge profile of ublituximab over the years
• 19:05 – Future plans of ubtlituximab; long-term goals of the therapy

• Eli Lilly Announces Date for Donanemab FDA AdComm Hearing

• Patient Death Reported in Phase 2 DAYLIGHT Study of Pfizer’s Gene Therapy for Duchenne

• ALS Candidate PrimeC Shows Greater Treatment Effect in High-Risk ALS

• 1:00 – Functionality of Neural Sleeve
• 2:45 – Feasibility and self-administration of Neural Sleeve
• 3:50 – Neurology News Minute
• 5:50 – Greatest clinical takeaways from pilot study
• 8:15 – Steps in advancing this therapeutic approach
• 9:45 – Challenges with gait in MS and personalizing treatment methods

• Gene Therapy LX2006 Positively Impacts Cardiac Biomarkers of Friedreich Ataxia, Clinical Data Show

• Buntanetap Transitioning to Crystal Form Following FDA Go-Ahead

• Endo Voluntarily Recalls One Lot of Clonazepam Tablets Following Mislabeling Error

• 1:10 – Step by step process on how Syn-One test is used; considerations after process is done
• 3:15 – How the test differentiates PD from other neurodegenerative disorders
• 9:50 – Neurology News Minute
• 12:20 – Value and role in assessing alpha-synuclein in PD
• 14:50 – Ways to further optimize Syn-One going forward

• FDA Approves Eli Lilly's Donanemab for Early Symptomatic Alzheimer Disease

• Buntanetap Improves Motor, Nonmotor and Cognitive Symptoms of Parkinson Disease in Phase 3 Study

• Gene Therapy AMT-130 Slows Huntington Disease Progression in Interim Phase 1/2 Trials

For more of NeurologyLive's coverage of donanemab's approval, head here: FDA Approves Eli Lilly's Donanemab for Early Symptomatic Alzheimer Disease

• 2:10 – Positive downstream impacts of donanemab's approval
• 4:20 – Considerations and caution with prescribing donanemab
• 6:05 – Salinas on patient-clinician conversations about AD treatments
• 8:00 – Closing remarks and continued progress in AD field

• 1:10 – Motivations behind conducting listening analysis
• 3:15 – Major clinical takeaways from study; notable quality of life impairments in narcolepsy
• 7:00 – Impact of cataplexy and patients' overreaction
• 9:50 – Neurology News Minute
• 12:20 – Reasons for missed and misdiagnosis
• 14:50 – Early tips to pathing patients towards treatment success

• FDA Grants Traditional Approval to Elevidys Gene Therapy for Ambulatory DMD, Accelerated Approval for Nonambulatory Patients

• FDA Approves Efgartigimod as New Treatment for Chronic Inflammatory Demyelinating Polyneuropathy

• FDA Approves Pitolisant for Excessive Daytime Sleepiness in Pediatric Narcolepsy

• Anthony Feinstein, PhD, FRCPC, MBBCh, a professor of psychiatry at the University of Toronto.
• Brian G. Weinshenker, MD, a professor of neurology at the University of Virginia.
• Douglas A. Wajda, PhD, an assistant professor of neurology and member of the Health and Human Performance Department in the College of Education at Cleveland State University.
• Le Hua, MD, director of Clinical Operations and director of the Multiple Sclerosis Program at Cleveland Clinic's Lou Ruvo Center for Brain Health in Las Vegas, Nevada. 
• Eion P. Flanagan, MB, BCh, a professor of neurology and chief of the Division of Multiple Sclerosis and Autoimmune Neurology at Mayo Clinic; and director of the Autoimmune Neurology Fellowship. 

• 1:40 – Feinstein on the difficulties with improving fatigue in multiple sclerosis and the lack of improvement seen from approved disease-modifying therapies.
• 5:20 – Weinshenker on the key diagnostic aspects of neuromyelitis optica spectrum disorder and how it differs from other similarly presenting autoimmune disorders.
• 9:40 – Wajda on the use of the Cionic Neural Sleeve, the advantages it holds, and how it may be used to treat gait dysfunction in multiple sclerosis.
• 12:00 – Hua on the differential diagnosis of pediatric-onset MS vs late-onset MS, and the notable biologic changes observed.
• 19:30 – Flanagan on the diagnostic pearls for MOG-antibody associated disease and the importance of early recognition of this group. 

• 1:05 – Mechanism of action of vorasidenib, a mIDH 1/2 inhibitor
• 2:00 – Overview of exploratory analysis results
• 4:20 – Significance of new data, how it adds to previous primary and secondary outcomes
• 5:50 – Neurology News Minute
• 8:25 – Next steps for the study and use of vorasidenib
• 10:35 – Remaining unmet needs for patients with diffuse gliomas

• Diazepam Buccal Film’s Role in Treating Intermittent Pediatric Seizures, with Michael Rogawski, MD, PhD

• Ocrelizumab Gains EU CHMP Positive Opinion for Subcutaneous Formulation to Treat MS

• FDA Approves Sprinkle Formulation of Neurocrine Biosciences’ Valbenazine for Tardive Dyskinesia or Huntington disease Chorea

• 1:05 – Decision behind removing AMX0035 from market
• 3:00 – Lessons from PHOENIX, AMX0035 drug development program
• 6:45 – Unraveling PHOENIX study data 
• 10:00 – Neurology News Minute
• 12:10 – Potential of AMX0035 in other tauopathies, neurologic conditions
• 15:00 – Outlook of antisense oligonucleotide AMX0114 in ALS

• Diazepam Buccal Film’s Role in Treating Intermittent Pediatric Seizures, with Michael Rogawski, MD, PhD

• Ocrelizumab Gains EU CHMP Positive Opinion for Subcutaneous Formulation to Treat MS

• FDA Approves Sprinkle Formulation of Neurocrine Biosciences’ Valbenazine for Tardive Dyskinesia or Huntington disease Chorea

For more of NeurologyLive's and Contemporary Pediatrics coverage of diazepam buccal film's approval, head here: FDA approves diazepam for seizure clusters in patients 2 to 5 years

• 0:20 – Diazepam buccal film approved for intermittent seizures in pediatrics
• 2:00 – Michael Rogawski, MD, PhD, giving reaction to the approval
• 4:10 – Flexibility with multiple diazepam administration routes
• 6:55 – Rogawski on the safety of diazepam buccal film amid high need
• 12:30 – Notable takeaways from the diazepam buccal film trial program

• 1:10 – Promise in the Alzheimer field in 2024
• 4:05 – Ways of improving efficiencies with drug develpment
• 9:10 – Discontinuation of aducanumab
• 11:10– Neurology News Minute
• 13:50 – Lessons learned from aducanumab, antiamyloid therapies 
• 22:10– Conversations between clinicians and patients surrounding expectations/limitations of antiamyloid therapies and available treatments

• FDA Agrees to New Specialized Protocol for Phase 3b Study of ALS Agent NurOwn

• FDA Approves Alternate Administration Routes for Antiseizure Medication Cenobamate

• Extended Use of Investigational Agent IPX203 Safe in Parkinson Disease

• 1:05 – Origin of the study
• 3:00 – Conduct of the study, end points, goals 
• 5:10 – Promising mechanism of action of dimethyl fumarate to treat Friedreich ataxia
• 7:30 – Questions in clinical impact of changes in frataxin
• 10:00 – Neurology News Minute
• 12:40 – What is considered a successful study?
• 14:55 – Patient inclusion, demographic makeup of the study
• 16:35 – Timeline of the trial and data readout

• FDA Approves Alexion's Ravulizumab-cwvz for Neuromyelitis Optica Spectrum Disorder
• Epilepsy Agent STK-001 Demonstrates Disease-Modifying Effects in Early Phase Studies of Dravet Syndrome
• Eisai Submits sBLA for Monthly Intravenous Maintenance Dosing of Alzheimer Therapy Lecanemab

For more of NeurologyLive's coverage of givinostat's approval, head here: FDA Approves Italfarmaco's Givinostat for Duchenne Muscular Dystrophy

• 0:30 – Givinostat approved for Duchenne muscular dystrophy
• 2:00 – Sharon Hesterlee, PhD, on the approval's implications
• 3:35 – Positive downstream effects of the approval
• 4:50 – Hersterlee on the safety profile of givinostat
• 5:40 – Promising outlook of the DMD field
• 6:45 – Overcoming roadblocks involved with gene therapy 
• 8:55 – Remaining unmet needs for patients with Duchenne
• 10:15 – Closing thoughts on the approval 

• 1:05 – Overviewing sessions from ACTRIMS Forum
• 13:10 – Innovating clinical trial design
• 16:15 – 2023 ACTRIMS vs 2024 ACTRIMS
• 20:20 – Neurology News Minute
• 23:30 – Testing combination approaches for progressive MS
• 26:45 – The impact of timing therapeutic interventions 

• FDA AdComm to Review Investigational Alzheimer Agent Donanemab and Phase 3 Results

• Amylyx Mulls Over Pulling AMX0035 Following Disappointing Phase 3 PHOENIX Findings

• FDA Issues Complete Response Letter for Long-Acting Form of Glatiramer Acetate for Relapsing Multiple Sclerosis

• Phase 2 PROCEED Trial of PACAP-Targeting Antibody Lu AG09222 in Migraine Announced

• 1:40 – Conversations needed to differentiate diagnoses
• 4:30 – Appearance of sleep disorders and overlap
• 6:50 – Complications with untreated sleep apnea
• 8:25 – Neurology News Minute
• 10:55 – Ways to improve adherence to medication
• 13:50 – Emerging research in the field

• Glatiramer Acetate Depot Demonstrates Sustained Longterm Safety Profile as Potential MS Therapy

• Phase 3 DAYBREAK Trial Highlights Long-Term Efficacy of Ozanimod for Relapsing Multiple Sclerosis

• SRP-9001 Improves Duchenne Muscular Dystrophy Disease Trajectory Despite Failing to Meet Primary End Point in Phase 3 EMBARK Trial

• 1:00 – Overviewing phase 1b/2a trial
• 7:05 – Mechanism of action of AB126
• 11:15 – Neurology News Minute
• 13:45 – Role of AB126 in stroke treatment landscape
• 17:50 – Challenges with repairing neurodegeneration in stroke

• European Commission Approves Omaveloxolone as First Therapy for Friedreich Ataxia

• AVP-786 Falls Short in Phase 3 Study of Alzheimer Disease Agitation

• FDA Grants Priority Review to Efficacy Supplement for Sarepta Therapeutics’ SRP-9001 Indication Expansion

• 1:10 – Meta-analysis overview
• 3:20 – Significance of results, how they add to the literature
• 6:50 – Feasibility of incorporating genetic screening into clinical trials
• 8:40 – Neurology News Minute
• 11:15 – Realistic expectations and potential with gene therapy
• 15:45 – Next steps in advancing this research

• Biogen Walks Away From Aducanumab to Prioritize Lecanemab and Alzheimer Disease Pipeline

• Updated Guidelines Published to Improve Care in Specialized Epilepsy Centers

• FDA Clears IND for Gene Therapy Candidate ETX101 in Dravet Syndrome

• 1:10 – Reasons behind studying sudden death in toddlers
• 3:55 – Notable takeaways from trial results
• 8:15 – Advancing ways to research SUDC/SUDEP
• 9:40 – Neurology News Minute
• 12:05 – Realistic ways to lower convulsive activity prior to sleep 
• 15:05 – What abnormal movements/noises can ellucidate
• 15:55 – Ways to expand the research further

• FDA Approves Takeda’s Immune Globulin Infusion, Hyqvia, for Chronic Inflammatory Demyelinating Polyneuropathy

• FDA Issues Complete Response Letter for Satsuma’s DHE Nasal Powder STS101 to Treat Acute Migraine

• ALS Agent PrimeC to Advance to Phase 3 Study After Positive PARADIGM Trial Data

• 1:15 – Idea behind studying stathmin-2
• 2:45 – Overviewing study results
• 7:05 – Next steps in extending this research
• 8:40 – Neurology News Minute
• 11:30 – Stathmin-2's connection with neurofilament light
• 12:55 – Potential of stathmin-2 as ALS-specific biomarker
• 14:45 – Future use of stathmin-2 in clinical trials
• 15:30 – Closing thoughts

• FDA Clears Phase 2 KYSA-7 Study of CAR T-Cell Therapy in Refractory Progressive Multiple Sclerosis

• Dyne Reports Positive Phase 1/2 Data for Duchenne Agent DYNE-251

• Parkinson Gene Therapy AB-1005 Meets Primary End Point in Phase 1b Trial

• VISIONARY-MS Trial Reports CNM-Au8 Improves Vision and Cognition in Multiple Sclerosis

• Sharon Cohen, MD, FRCPC, behavioral neurologist and medical director of the Toronto Memory Program at the University of Toronto, and a trial investigator for Clarity AD, the phase 3 trial of lecanemab. 
  • Check out the full episode here: https://www.neurologylive.com/view/special-episode-lecanemab-approved-for-alzheimer-disease
• Robert A. Hauser, MD, MBA, director of the Parkinson’s and Movement Disorders Center at the University of South Florida.
  • Check out the full episode here: https://www.neurologylive.com/view/episode-81-widening-therapeutic-window-parkinson-disease
• Alberto Espay, MD, PhD, the division director and Research Endowed Chair of the James J. and Joan A. Gardner Family Center for Parkinson’s Disease and Movement Disorders, and a professor of clinical neurology and rehabilitation medicine at the University of Cincinnati.
  • Check out the full episode here: https://www.neurologylive.com/view/episode-94-discussion-leqembi-lecanemab-approval-alzheimer-disease
• Carolina Ferreira Atuesta, MD, MSc, a scientific researcher and clinical data manager at the Icahn School of Medicine at Mount Sinai.
  • Check out the full episode here: https://www.neurologylive.com/view/episode-82-managing-seizures-after-ischemic-stroke
• Natalie Goedeker, CPNP, a nurse practitioner in neurology in the Neuromuscular Division at Washington University in St Louis.
  • Check out the full episode here: https://www.neurologylive.com/view/special-episode-tofersen-approved-sod1-als

• 1:20 – Cohen on the safety of lecanemab, including the 3 patient deaths reported in the supportive clinical trial program. 
• 6:25 – Hauser on the clinical advantages of IPX203, a potential new carbidopa/levodopa formulation for patients with Parkinson disease. 
• 9:20 – Espay on tempering expectations of lecanemab and other antiamyloid therapies in the treatment of Alzheimer disease.
• 13:20 – Atuesta on the lack of standardized methods for monitoring patients with poststroke seizures, including elders.
• 17:00 – Goedeker on the approval of gene therapy SRP-9001 for patients with Duchenne muscular dystrophy, the integration process, and safety considerations clinicians should be aware of.

• 1:10 – Overview of post-hoc analysis of REST-ON
• 3:15 – Differences in type 1 and 2 narcolepsy
• 5:50 – Neurology News Minute
• 8:15 – Expanding treatment profile of once-nightly sodium oxybate
• 10:55 – Lingering unmet needs of patients with narcolepsy
• 11:20 – Realistic timeline of gene therapies for epilepsy
• 14:00 – Future of narcolepsy research, drug development trials

• FDA Places Clinical Hold on Roche’s BTK Inhibitor Fenebrutinib for Multiple Sclerosis

• ALS Candidate PrimeC Meets Primary Safety and Secondary End Points in Phase 2b PARADIGM Study

• FDA Clears NeuroOne’s OneRF Ablation System for Neurosurgerical Procedures

• 1:10 – State of pediatric epilepsy
• 2:15 – Screening potential candidates for epilepsy surgery
• 5:00 – Advances in seizure localization
• 7:15 – Neurology News Minute
• 9:25 – Balance of nonpharmacological approaches
• 11:20 – Realistic timeline of gene therapies for epilepsy
• 13:15 – Future plans for research, current unmet needs

• FDA Clears AI-Powered Brain MRI Software Pixyl.Neuro

• FDA Grants Meeting With BrainStorm Cell Therapeutics on ALS Therapy NurOwn

• FDA Warns of Serious Adverse Effects for Using Levetiracetam and Clobazam in Epilepsy

• 1:10 – Overview of phase 2 OVERTURE study
• 4:45 – Mechanism of action of gamma sensory stimulation 
• 10:00 – Potential therapeutic crossover with emerging treatments
• 12:30 – Neurology News Minute
• 14:50 – Feasibility of the stimulation device
• 18:20– Future plans and planned phase 3 study

• ATA188 Fails to Meet Primary End Point In Phase 2 EMBOLD Study of Progressive MS

• Elecsys Neurofilament Light Test Gains Breakthrough Device Designation as Way to Track MS Disease Activity

• FDA Clears Phase 2 Study of CAR T-Cell Therapy KYV-101 in Myasthenia Gravis

For more of NeurologyLive's coverage of vamorolone's approval, head here: FDA Approves Vamorolone as a Treatment for Duchenne Muscular Dystrophy

• 0:30 – Vamorolone approved for Duchenne muscular dystrophy
• 2:20 – Barry J. Byrne, MD, PhD, on his immediate reaction
• 3:25 – Safety data on vamorolone
• 4:00 – Byrne on the importance of bone mineralization in DMD
• 5:10 – Phase 2b efficacy data from VISION-DMD
• 5:45 – Byrne with context on the efficacy data
• 7:05 – Byrne with context on the landscape of DMD therapeutic development and personalization approaches

• 1:10 – Overview of MDS presentation
• 2:40 – Reasons for complexities with freezing in parkinsonism
• 4:35 – Aspects of deep brain stimulation care that need improvement
• 7:00 – Neurology News Minute
• 9:15 – Promising neuromodulation targets in the brain
• 12:35 – Finding optimal candidates for specific neurosurgery procedures
• 18:50 – Future research of neuromodulation in Parkinson disease

• Eisai Plans to Submit BLA for Subcutaneous Lecanemab After Findings Show Promising Results

• FDA Approves Vamorolone as a Treatment for Duchenne Muscular Dystrophy

• SRP-9001 Fails to Meet Primary End Point in Phase 3 EMBARK Study

For more of NeurologyLive®'s coverage of zilucoplan's approval, head here: FDA Approves Complement C5 Inhibitor Zilucoplan as Treatment for Myasthenia Gravis

• 0:30 – Zilucoplan approved for AChR+ myasthenia gravis
• 1:40 – James F. Howard, MD, on his immediate reaction
• 3:30 – Safety data from the RAISE trial
• 4:25 – Howard on the potential advantages of zilucoplan
• 6:50 – Phase 3 efficacy data for zilucoplan
• 7:55 – Howard with context on the efficacy and the challenges with therapeutic availability in myasthenia gravis
• 12:10 – Howard, on the future of therapeutic development

• Mitzi Joi Williams, MD, founder and chief executive officer of the Joi Life Wellness Group Multiple Sclerosis Center.
• Rhonda Voskuhl, the director of the Multiple Sclerosis Program at UCLA.
• Tom Fuchs, MD, PhD, a research fellow at the MS Center at Amsterdam University Medical Center.
• Barry Singer, MD, the director and founder of The MS Center for Innovations in Care.
• Georgina Arrambide, a clinical neurologist in the MS Center of Catalunya.

• 1:10 – Joi Williams on expanding the use of biomarkers and the next steps in advancing precision medicine for multiple sclerosis treatment.
• 2:20 – Voskuhl on the increased research efforts to better understand the links between aging, menopause, and women with MS.
• 4:30 – Fuchs on the challenges of tracking cognitive decline in multiple sclerosis and improving currently available assessments.
• 7:50 – Singer on the introduction of biosimilars to MS care, the rigorous approval process they undergo, and the potential benefits they bring to the field.
• 11:45 – Arrambide on an updated consensus approach to the differential diagnosis of suspected multiple sclerosis, and the red flags clinicians should be aware of during this process.

• 1:15 – Underlying mechanisms of progressive supranuclear palsy
• 3:30 – Similarities and differences between ALS and PSP
• 5:00 – Overview of ORION study design
• 7:00 – Neurology News Minute
• 9:15 – Reasons behind specific trial inclusion
• 10:35 – Primary end points of the study 
• 12:50 – Significance of a potentially successful trial

• FDA Advisory Committee Downvotes Mesenchymal Stem Cell Approach NurOwn as Potential ALS Therapy

• FDA Approves HoneyNaps’ Artificial Intelligence Sleep Disorder Diagnosis Software

• FDA Approves Cipaglucosidase Alfa and Miglustat as First Two-Component Therapy for Pompe Disease

• 1:15 – Overview of Medicare study and objectives
• 3:15 – Advantages of DVC System
• 5:40 – Clinical takeaways from the findings
• 9:30 – Neurology News Minute
• 12:05 – Critical phenotypic features of narcolepsy 
• 14:20 – Significance of this research, future goals

• Alzheimer Agent ALZ-801 Improves Cognition, Reduces Relevant Biomarker Levels in 2-Year Analysis

• FDA Updates Label for Psychosis Medication Pimavanserin

• FDA Approves AI-Incorporated Alzheimer Detection Software AIRAscore

• 1:15 – Overview of Medicare study and objectives
• 2:20 – Greatest clinical take-home points from the data
• 4:15 – Utilizing resources to cover gaps in access
• 5:30 – Neurology News Minute
• 8:05 – Reasons for lack of mental health professional support
• 10:55 – Challenges with understanding depression in PD
• 12:35 – Ensuring access to PD care in rural/underserved communities

• FDA Approves Sandoz’s Natalizumab-sztn as First Biosimilar for Multiple Sclerosis

• Duchenne Agent Pamrevlumab Fails to Meet Primary End Point in Phase 3 LELANTOS-2 Trial

• FDA Issues Ravulizumab Complete Response Letter for NMOSD, Citing Needed Changes to REMS Program

• 1:15 – Objectives of DAVOS Project, overview of presentation from AAIC
• 6:55 – Complexities and challenges with screening in primary care settings
• 10:30 – Neurology News Minute
• 13:25 – Incorporating screening procedures with emerging therapies
• 12:30 – Future role of digital technologies and blood tests

• FDA Approves Expanded Indication of DaxibotulinumtoxinA to Treat Cervical Dystonia

• Exon 44 Skipping Agent AOC 1044 Granted FDA Orphan Drug Designation for Duchenne Muscular Dystrophy

• CGRP Medication Atogepant Gains European Commission Approval as Migraine Preventive

• FDA Approves Neurocrine Biosciences’ Valbenazine for Huntington Disease Chorea

For more of NeurologyLive®'s coverage of valbenazine's expanded indication, head here: FDA Approves Neurocrine Biosciences’ Valbenazine for Huntington Disease Chorea

• 0:30 – Valbenazine approved for Huntington disease chorea
• 1:35 – Erin Furr-Stimming, MD, FAAN, FANA, on immediate reaction
• 2:15 – Treatment toolbox for HD chorea 
• 3:05 – Furr-Stimming on mechanistic advantages of valbenazine
• 5:10 – Phase 3 efficacy data of valbenazine
• 5:55 – Furr-Stimming on greatest clinical takeaways from trials
• 6:55 – Current state of Huntington management
• 8:00 – Furr-Stimming on current unmet needs for patients, including research on disease-modifying therapies

• 1:20 – Benefits seen with nusinersen in NURTURE 
• 4:10 – Changes in goals for treating SMA
• 6:05 – Complexities with getting infants therapy days after diagnosis
• 9:40 – Neurology News Minute
• 12:30 – Subgroup findings from NURTURE
• 15:20 – Ways to improve treatment optimization in SMA

• World Health Organization Adds Several MS Treatments to List of Essential Medicines
• Ceribell's Status Epilepticus Software Receives FDA Clearance With CMS NTAP Coverage Included
• FDA Accepts New Drug Application for Long-Acting Form of Glatiramer Acetate
• Essential Tremor Agent Ulixacaltamide Continues to Show Positive Results in Essential1 Study

• 1:45 – Introduction and main findings
• 3:15 – Espay, with his perspective on the downstream effects of the approval
• 10:10 – Porsteinsson, with his perspective on the downstream effects of the approval
• 18:30 – Secondary end points and safety data
• 20:05 – Porsteinsson, on the recent progress in AD
• 23:05 – Espay, on contextualizing the effect of amyloid clearance
• 26:00 – Porsteinsson, on the logistics of the approval
• 34:20 – Espay, on the lingering unanswered questions
• 38:20 – Espay, on the communication of data to the public around the amyloid therapies
• 42:25 – Porsteinsson, on how things evolve going forward

• Alberto Espay’s lecanemab data infographic
• Lecanemab CLARITY data
• Donanameb TRAILBLAZER data

• FDA Grants Traditional Approval to Lecanemab as Therapy for Early-Stage Alzheimer Disease
• Medicare Expands Coverage for Fully Approved Alzheimer Agent Lecanemab
• Lecanemab to be Tested in Preclinical Alzheimer Disease
• Therapeutics Aim at Modifying Alzheimer Disease

• David Bates, PhD: Downstream Impacts of Lecanemab on Alzheimer Disease, Future Drug Development
• Howard Fillit, MD: Lecanemab’s Impact on Care and Diagnosis and the Future of Alzheimer Disease Treatment
• Nicole Fowler, PhD, MHSA: Preparing Primary Care Centers for New Wave of Alzheimer Agents
• Ronald C. Petersen, MD, PhD: Lessons Learned About Clinically Meaningful Benefit from Antiamyloid Trials
• Sharon Cohen, MD, FRCPC: Significance of Expanding Antiamyloid Therapy Class, Toolbox to Treat Alzheimer

• 1:15 – The presentation of Parkinson disease for women
• 3:00 – Nonmotor symptoms that can create challenges for diagnosis
• 4:45 – OFF episodes and dyskinesia in women vs men
• 7:00 – Being attentive to patient needs in treatment
• 10:20 – The daily impact of Parkinson disease
• 13:05 – Neurology News Minute
• 16:30 – Encouraging women with Parkinson to participate in trials
• 18:30 – Barriers to care specific to women
• 20:00 – Communication with women patients
• 22:20 – Areas of need for research
• 23:35 – Conversations in areas of limited knowledge
• 25:20 – Closing thoughts

• FDA Issues Complete Response Letter to Amneal for Parkinson Agent IPX203
• FDA Grants Traditional Approval to Lecanemab as Therapy for Early-Stage Alzheimer Disease
• Medicare Expands Coverage for Fully Approved Alzheimer Agent Lecanemab
• FDA Approves Image Guided Programming Software for Vercise Deep Brain Stimulation Systems

• Amit Bar-Or, MD, FRCPC, FAAN, FANA, the Melissa and Paul Anderson President’s Distinguished Professor at the Perelman School of Medicine of the University of Pennsylvania.
• Gavin Giovannoni, MBBCh, PhD, FCP, FRCP, FRCPath, a professor of neurology at Barts and The London School of Medicine and Dentistry.
• Dayna Johnson, PhD, MPH, MSW, MS, a sleep epidemiologist and assistant professor at the Rollins School of Public Health at Emory University.
• John Winkelman, MD, PhD, the chief of the Sleep Disorders Clinical Research Program at Massachusetts General Hospital.
• Laxman Bahroo, DO, a professor of neurology and the residency program director at MedStar Georgetown University Hospital.
• Ling Wan-Albert, OTD, OTR/L, an assistant professor of occupational therapy at the New York Institute of Technology.
• Sara Pavitt, MD, the chief of headache at UT Austin Dell Children’s Hospital.
• Ali Ezzati, MD, the director of the Neuroinformatics Program at the University of California, Irvine.

• Consortium of Multiple Sclerosis Centers Annual Meeting
• SLEEP, the Joint American Academy of Sleep Medicine and the Sleep Research Society Meeting
• Advanced Therapeutics in Movement and Related Disorders Congress
• American Headache Society Annual Scientific Meeting

• 1:15 – Bar-Or on the potential of BTK inhibition in multiple sclerosis at CMSC 2023
• 4:40 – Giovannoni on the understanding of MS as a smoldering disease at CMSC 2023
• 10:30 – Johnson on multilevel efforts to address modifiable factors of sleep health at SLEEP 2023
• 13:05 – Winkelman on moving away from dopamine agonists as first-line treatments for restless legs syndrome at SLEEP 2023
• 15:30 – Bahroo on the role of botulinumtoxins in Parkinson disease care at ATMRD 2023
• 19:00 – Wan-Albert on the impact of social isolation on cognition at ATMRD 2023
• 22:10 – Pavitt on the universal knowledge about pediatric headache for neurologists and nonspecialists at AHS 2023
• 24:05 – Ezzati on the use of machine learning models to improve treatment optimization in heterogenous migraine at AHS 2023

For more of NeurologyLive®'s coverage of SRP-9001's approval, head here: FDA Approves SRP-9001 as First Gene Therapy for Duchenne Muscular Dystrophy

• 0:30 – SRP-9001 (Elevidys; Sarepta) is approved for DMD
• 1:35 – Natalie Goedeker, CPNP, on the approval
• 3:05 – Efficacy of SRP-9001
• 4:00 – Goedeker on pieces of efficacy data released
• 4:45 – Currently available therapies for DMD
• 5:35 – Goedeker on role of SRP-9001 in treatment landscape
• 6:55 – Safety data of SRP-9001
• 8:00 – Goedeker on safety considerations of which prescribing clinicians should be aware

• 1:15 – Factors at play in obstructive sleep apnea
• 3:40 – Literature on the gut microbiome's role in sleep
• 5:55 – Lingering needs in narcolepsy treatment
• 8:30 – Neurology News Minute
• 12:40 – The effect of disrupted nighttime sleep
• 15:45 – Emerging concepts in sleep medicine

• Biogen and Denali Terminate Phase 3 LIGHTHOUSE Study of BIIB122 in LRRK2-related Parkinson Disease
• FibroGen's Duchenne Muscular Dystrophy Antibody Pamrevlumab Falls Short in Phase 3
• Phase 2/3 Study of Blarcamesine in Pediatrics With Rett Syndrome Completes Enrollment
• FDA Places Hold on Phase 1 Study of Exon Skipping Therapy PGN-EDODM1 in Myotonic Muscular Dystrophy
• FDA Panel Votes in Favor of Eisai’s Lecanemab for Early Alzheimer Disease
• Post-Marketing Study of Andexanet Alfa Stopped Early After Achieving Prespecified Efficacy

• 1:15 – Breaking down the signs and symptoms of stroke with B.E. F.A.S.T
• 2:45 – The importance of stroke awareness
• 3:55 – Treating patients with poststroke symptoms
• 5:45 – Neurology News Minute
• 10:40 – Notable risk factors for stroke
• 13:15 – The critical need for novel education tools in stroke

• Potential Path for Phase 3 Study of AOC 1001 in Myotonic Dystrophy Becomes Clear After FDA Ease’s Clinical Hold

• FDA Grants Fast Track Designation for Atrial Fibrillation Therapy Asundexian

• FDA Pushes Back Decision Date for Duchenne Gene Therapy SRP-9001

• FDA Accepts NDA for DHE Nasal Powder Product STS101 for Acute Migraine

• CMS Announces Plan to Provide Coverage of Antiamyloid Therapies for Alzheimer Disease

• 1:15 – Clinical development program of CNM-Au8
• 3:40 – Safety findings, treatment responses of CNM-Au8
• 4:20 – Next steps in research 
• 6:25 – Neurology News Minute
• 8:45 – Conducting safe trials 
• 10:00 – Remaining unmet needs for patients with ALS
• 11:15 – Need for additional research

• FDA Approves Brexpiprazole as First Therapy for Alzheimer Agitation

• FDA Panel Votes in Favor of Gene Therapy SRP-9001 for Duchenne Muscular Dystrophy in Tight Decision

• Alzheimer Agent COYA 301 Halts Cognitive Decline, Restores Regulatory T Cell Dysfunction in Phase 1 Study

• Phase 2 Data Highlight Fenebrutinib's Impact on Brain Lesions in Relapsing Multiple Sclerosis

• Michael H. Barnett, MBBS, PhD, FRACP, a consultant neurologist at Royal Prince Alfred Hospital (RPAH) Sydney, director of the RPAH MS Clinic and the MS Clinical Trials Unit at the Brain and Mind Centre; codirector of the MS Research Australia Brain Bank; and a senior professor at the University of Sydney.
• Nancy R. Foldvary-Schaefer, DO, FAAN, the director of the Sleep Disorders Center and staff in the Epilepsy Center at Cleveland Clinic, and a professor of medicine at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University.
• Sean J. Pittock, MD, the director of the Center for Multiple Sclerosis and Autoimmune Neurology and director of the Neuroimmunology Research Laboratory at Mayo Clinic.
• Katherine W. Turk, MD, a neurologist at Boston VA Memory Disorders Clinic, principal investigator and codirector of the Center for Translational Cognitive Neuroscience lab (CTCN) at VA Boston; and assistant professor of neurology and coleader of the Outreach, Recruitment and Engagement core of the Alzheimer’s Disease Research Center at Boston University.
• Erika U. Augustine, MD, MS, the associate chief science officer and director of the Clinical Trials Unit at the Kennedy Krieger Institute.
• Jeffrey M. Statland, MD, a neuromuscular disease specialist and professor of neurology at the University of Kansas Medical Center.
• Chian-Chun Chiang, MD, a stroke and migraine specialist and assistant professor of neurology at Mayo Clinic.

• 1:10 – Barnett on the topline findings for CNM-Au8 from the VISIONARY-MS clinical trial.
• 8:35 – Foldvary-Schaefer on the understanding of the relationship between epilepsy and sleep.
• 13:25 – Pittock on the latest data on ravulizumab from the CHAMPION-NMOSD trial.
• 19:00 – Turk on the landscape of diagnosis and treatment for mild cognitive impairment, and how to improve the process.
• 22:00 – Augustine on Dr. Sidney Carter and the current paradigm of care in child neurology.
• 27:15 – Statland on the findings for ataluren in nonsense mutation Duchenne muscular dystrophy from Study 041.
• 34:05 – Chiang on the takeaways from a big data analysis of 25 therapies for acute migraine management.

For more of NeurologyLive®'s coverage of tofersen's approval, head here: FDA Approves Tofersen as First SOD1-ALS Treatment

• 0:30 – Tofersen (Qalsody; Biogen/Ionis) approved for SOD1-ALS
• 1:35 – Angela Genge, MD, FRCPC, on the approval
• 3:05 – The implications of targeting a root cause of ALS
• 5:00 – Data from the supporting VALOR study
• 5:55 – Genge on the context around the trial data
• 7:35 – Questions about access to tofersen amid accelerated approval

• 1:10 – Background on the CASA-MS study subpopulation
• 3:45 – Topline results of the study
• 6:05 – The need for further clarification in MS populations
• 7:10 – The utility of biomarkers such as GFAP
• 12:15 – Further assessment plans for the CASA-MS cohort
• 14:15 – Neurology News Minute
• 18:35 – Access to the tools to characterize progressive MS
• 21:30 – The potential with portable MRI and artificial intelligence
• 25:25 – Unmet needs in progressive MS

• Phase 3 Study of GTX-104 in Subarachnoid Hemorrhage Expected to Proceed Following FDA Feedback

• FDA Places Partial Hold on Evobrutinib Initiation in Newly Enrolled Patients With MS

• FDA Panel Votes in Favor of Brexpiprazole as Potential Therapy for Alzheimer Agitation

• FDA Approves IntelGenx and Gensco's Rizatriptan for Acute Migraine Treatment

• DEA Rules Fenfluramine No Longer a Controlled Substance

• Atogepant’s Indication Expanded to Include Prevention of Chronic Migraine

• FDA Grants Breakthrough Device Designation to Reach Neuro’s Chronic Stroke Platform

• FDA Approves CSL Behring's Immune Globulin Subcutaneous Prefilled Syringe for PI and CIDP

• 1:10 – Mechanistic differences between pimavanserin and other atypical antipsychotics
• 3:00 – Understanding drug-to-drug interactions for PDP
• 5:05 – Decision making with quetiapine and negative cognitive effects
• 7:10 – Improved use of pimavanserin since approval
• 9:00 – Neurology News Minute
• 11:40 – Potential predictors of mortality in Parkinson disease psychosis
• 15:20 – Possibility of preventing PD psychosis
• 17:20 – Future research on identifying subgroups of responders to treatment

• Tiziana Announces Planned Phase 2 Study of Foralumab in Progressive Multiple Sclerosis

• Blarcamesine Deemed Safe, Effective in Phase 2 Extension Study of Parkinson Disease Dementia

• Eplontersen Continues to Show Clinical Benefit in Long-Term Analysis of hATTR Polyneuropathy

• Reldesemtiv to be Discontinued in ALS Following Data Monitoring Committee Analysis

• 1:20 – Identified links between narcolepsy and social relationships
• 3:05 – Long-term impacts of affected mood, physical activities, and driving 
• 4:15 – Current assessment of narcolepsy in adolescents
• 5:30 – Neurology News Minute
• 8:05 – Attempts to prevent narcolepsy at earliest stages
• 9:15 – Implementing programs in school to help adolescents with narcolepsy
• 11:20 – Future research on narcolepsy in younger populations

• FDA to Hold AdComm Meeting for Investigational DMD Treatment SRP-9001

• Treg Suppressing Agent COYA 302 Shows Slowing of ALS Disease Progression

• FDA Issues Complete Response Letter for AbbVie’s 24-Hour Continuous Carbidopa/Levodopa Pump

• FDA AdComm Panel Supports Neurofilament Light as Surrogate Biomarker for Tofersen, With Questions Regarding Clinical Benefit

For more of NeurologyLive®'s coverage of trofinetide's approval, head here: FDA Approves Acadia's Trofinetide for Rett Syndrome

• 0:30 – Trofinetide (Daybue; Acadia) approved for Rett syndrome
• 1:30 – Jeffrey L. Neul, MD, PhD, on the approval
• 4:10 – Prevalence of Rett syndrome and the impact on research
• 5:40 – Supporting data from the phase 3 LAVENDER study
• 7:20 – Safety data from the clinical development and managment of common adverse events
• 8:45 – Closing thoughts

• 1:20 – The need for education across the PD care paradigm
• 4:40 – An overview of the 6-part educational series 
• 6:10 – The inclusion of specialties such as dentistry in the care of PD
• 9:40 – Using training to overcome gaps in multidisciplinary care
• 13:05 – Challenges in educating a large population of providers
• 16:55 – Neurology News Minute
• 19:00 – Improving access to clinical education
• 24:07 – The Foundation’s goal to inspire learning to improve care
• 26:30 – Closing thoughts

• FDA Approves Theranica's Nerivio for Preventive Treatment of Migraine
• FDA Approves Omaveloxolone As First Treatment for Friedreich Ataxia
• FDA Accepts Supplemental BLA for Traditional Approval of Lecanemab
• FDA Clears Abbott’s Alinity i Lab-Based Blood Test for Traumatic Brain Injury

• 1:20 – Overview of ARISE and conduct of study
• 4:20 – Potential subgroup responders to dimethyl fumarate
• 8:10 – Efforts to improve the detection of radiologically isolated syndrome
• 10:05 – Neurology News Minute
• 11:55 – Next steps of research following ARISE
• 16:50 – Closing thoughts on significance of the study

• CNM-Au8 Shows Positive Findings on MS-Related Biomarkers of Whole Brain, White Matter

• Aducanumab’s Label Updated to Include Risks on Brain Bleeding

• Primary Care Physicians Show Greater Confidence in Diagnosing Alzheimer Disease Through DISCERN Skin Test
• FDA Approves Extended-Release Deutetrabenazine for Huntington Disease Chorea, Tardive Dyskinesia

• 1:20 – Background on the multicenter study
• 3:30 – Goals of the study and main findings
• 5:25 – Surprising findings from the study
• 6:50 – The understanding of this association in clinical care
• 9:25 – Neurology News Minute
• 11:55 – Current state of prognostication post stroke
• 16:50 – The lack of standardized approach to monitoring
• 20:50 – Lingering needs for future studies
• 22:55 – Closing thoughts

• FDA Accepts New Drug Application for Duchenne Therapy Vamorolone
• Enrollment for Pivotal Phase 3 PHOENIX Study of AMX0035 Completed
• Alzheimer’s Association Panel Offers Considerations for New Definition of Meaningful Change in Drug Trials
• Sanofi Discontinues Phase 3 Study of Tolebrutinib in Myasthenia Gravis

• 1:20 – Lingering unmet needs in Parkinson disease management
• 3:10 – The advances in identifying therapeutic targets in PD
• 4:25 – Bridging the gap to more effective long-term treatment
• 6:00 – Overview of IPX203 and its potential to treat PD
• 7:45 – Neurology News Minute
• 10:15 – Possible advantages of IPX203
• 13:25 – Safety profile of IPX203 in clinical development
• 15:50 – The importance of addressing dose-wearing off
• 16:40 – Closing thoughts

• Neurelis Files IND for Potential First Therapy to Treat Cerebral Cavernous Malformations
• CDC and FDA Announce Stroke Safety Concern Related to Pfizer-BioNTech Bivalent COVID-19 Vaccine
• FDA Hands Eli Lilly Complete Response Letter for Donanemab After Lack of Long-Term Data
• FDA Clears Trial Hold on Late-Onset Pompe Disease Gene Therapy AT845
• Proclaim XR Spinal Cord Stimulation Wins Approval for Painful Diabetic Peripheral Neuropathy

• 1:20 – Current limitations with RNA therapies
• 4:50 – The decision to focus on rare genetic muscle diseases
• 7:45 – The patient needs in DM1, FSHD, and DMD
• 9:05 – Neurology News Minute
• 12:25 – Other clinical areas of focus and collaboration for Avidity
• 14:10 – Upcoming data presentations planned for 2023 in DMD and myotonic dystrophy
• 16:15 – The benefits of collaboration in the rare disease community
• 18:15 – Looking ahead to the future of therapies in rare muscular disease

• Anti-CD20 Therapy Ublituximab Gains FDA Approval for Relapsing Multiple Sclerosis
• FDA Clears First Stroke-Specific Radial Access Platform for Mechanical Thrombectomy
• FDA Designates Myasthenia Gravis Agent Rozanolixizumab Application for Priority Review
• FDA Approves Eisai’s Lecanemab for the Treatment for Alzheimer Disease
• FDA Accepts sBLA for Revance’s Cervical Dystonia Treatment DaxibotulinumtoxinA

For more of NeurologyLive®'s coverage of lecanemab's approval, head here: FDA Approves Eisai’s Lecanemab for the Treatment for Alzheimer Disease

• 0:30 – Lecanemab (Leqembi; Eisai) approved for Alzheimer disease
• 1:35 – Sharon Cohen, MD, FRCPC, on the approval
• 3:15 – Supporting context on the accelerated approval pathway for lecanemab
• 4:50 – Questions about access amid current CMS guidance
• 6:25 – Data from the supporting phase 2 study, Study 201
• 7:15 – Safety and the 3 patient deaths reported in the clinical trial program

• 1:20 – Lecanemab's safety profile from Clarity AD
• 4:15 – Amyloid-related imaging abnormalities and lecanemab use
• 6:40 – The landscape of Alzheimer disease therapeutics
• 8:10 – Neurology News Minute
• 10:15 – What research has revealed about treatment approaches
• 13:00 – How clinical trials have evolved in dementia research
• 14:40 – The possibility of induction therapy in Alzheimer disease
• 16:30 – Looking ahead to the next steps in treatment development
• 18:00 – Progress toward treating Alzheimer disease earlier

• Roche Gets FDA Clearance for CSF Beta-Amyloid and Phospho-Tau Alzheimer Disease Assays
• BrainStorm Submits Type A Meeting Request Regarding NurOwn ALS Treatment
• Seizure-Free Days and Duration Intervals Increased with Fenfluramine in Dravet Syndrome

• 1:20 – An overview of the state of virtual reality in medicine
• 2:20 – The Cleveland Clinic Virtual Reality Shopping platform
• 6:45 – The importance of mimicking the details of reality
• 8:05 – Misconceptions and surprises with VR for Parkinson disease
• 11:45 – Neurology News Minute
• 15:05 – How VR can be used in prodromal Parkinson disease 
• 19:00 – Biomarkers for Parkinson disease
• 21:15 – Using VR as a targeted therapy
• 23:20 – The opportunity in medicine with VR systems

• International Committee Proposes MS Disease Progression Framework Driven by Pathophysiological Mechanisms, Not Clinical Phenotype
• Anti-Amyloid-ß Oligomer Antibody ACU193 Gains FDA Fast Track Designation
• Duchenne Gene Therapy SRP-9001 Wins Priority Review
• Lecanemab Represents Promising Therapy for Alzheimer Disease, Posts Positive Phase 3 Secondary Analyses
• Donanemab Shows Greater Ability to Clear Amyloid Plaque Than Aducanumab

• 1:15 – The perspective on the current state of care in myasthenia gravis
• 4:05 – The rapidly evolving treatment landscape
• 6:40 – Allegheny Health Network's approach to myasthenia gravis care
• 10:05 – Treatment selection among patient groups
• 15:45 – Neurology News Minute
• 18:45 – Current challenges and adjustments with treatments
• 21:20 – Nonpharmacologic approaches to myasthenia gravis
• 26:55 – Challenges for patients and education around treatment access
• 28:35 – The future of myasthenia gravis care

• Neurosteer Single-Channel EEG Platform Cleared by FDA
• Neurocrine Biosciences Submits Supplemental NDA for Valbenazine in the Treatment of Huntington Disease Chorea
• FDA Refuses to File BrainStorm’s BLA for NurOwn Mesenchymal ALS Therapy
• FDA Accepts NDA for Parkinson Disease Treatment IPX203
• FDA Accepts NDA for Myasthenia Gravis Treatment Zilucoplan

• 1:15 – Darin Okuda, MD, on the implications of the ARISE data in RIS
• 5:50 – Federica Picariello, PhD, on addressing fatigue and its mechanisms
• 10:40 – Brenda Banwell, MD, on advances in pediatric-onset MS
• 16:05 – Riley Bove, MD, on treatment NMOSD in pregnancy and post partum
• 21:30 – Tomas Kalincik, MD, PhD, on stem cell transplantation in MS
• 27:00 – Marisa McGinley, DO, on the optimal experience of teleneurology

• 1:15 – Richard Isaacson, MD, on his experience
• 3:20 – Stephen Krieger, MD, on his experience
• 6:20 – Jessica Ailani, MD, on her experience
• 9:45 – Krieger on the benefits of cross-specialty interactions
• 11:25 – Isaacson on the concept of earlier identification of disease
• 14:25 – Ailani on increasing diversity and discussion across neurology
• 16:00 – Krieger on the takeaways from COVID-19 in multiple sclerosis
• 18:55 – Ailani on the challenges of comorbidity and telemedicine
• 20:55 – Isaacson on the need to focus on the future of neurology

• 1:15 – The positives of digital therapeutics in insomnia care
• 3:50 – Overview of a recent study from Maricich and colleagues
• 8:40 – Prioritization of sleep in clinical care
• 11:20 – Lack of clinical use of prescription digital therapeutics
• 13:05 – Neurology News Minute
• 15:30 – Differences for CBT-I among treatment-naïve individuals
• 18:05 – Use of CBT-I as a supplementary treatment tool
• 20:10 – Research needs and ongoing efforts
• 23:15 – What clinicians need to know about CBT-I and digital therapeutics
• 25:50 – Closing thoughts

• Alzheimer Disease Agent Lecanemab Shows Reduction in CDR-Sum of Boxes in Clarity AD
• Verdiperstat Fails to Differentiate From Placebo in Critical HEALEY ALS Platform Trial
• AMX0035 Approved for the Treatment of ALS
• CNM-Au8 Shows Survival Benefit in HEALEY ALS Trial, But Fails to Meet End Points

• 1:15 – Overview of palliative care and its purpose
• 5:40 – Differences between hospice and palliative care
• 7:55 – History of palliative care in the United States
• 12:25 – Palliative care's fit in neurologic care
• 15:10 – Neurology News Minute
• 17:10 – Benefits of care for caregivers
• 21:15 – Palliative care resources and societies
• 22:30 – Neuropalliative care and its current goals
• 26:30 – Benefits for clinicians of implementing neuropalliative care
• 30:20 – Recommendations for physicians
• 36:00 – Tips for trying palliative care practices and findings resources

• FDA Accepts Application for Trofinetide in Rett Syndrome
• LIFT-AD Study Amended to Assess Alzheimer Disease Agent Fosgonimeton as Monotherapy
• Tolerizing MS Vaccine Displays Efficacy in Model of Relapsing-Remitting Multiple Sclerosis

• 1:15 – The rise of neurostimulation in epilepsy care
• 4:00 – Increasing implantation of minimally invasive options
• 5:15 – Patient reception to nontherapeutic approaches
• 7:45 – The impact of cenobamate (Xcopri; SK Life Science) on the paradigm
• 10:35 – Managing refractory epilepsy
• 12:00 – Upcoming options for those with generalized epilepsy
• 13:50 – Neurology News Minute
• 18:30 – Path forward for gene and cell therapies in epilepsy
• 21:00 – The need to improve early recognition of epilepsy
• 25:20 – Standardizing questionnaires and information for epilepsy
• 27:00 – The need to continue discussing SUDEP

• FDA Approves Midazolam Autoinjector for Status Epilepticus
• Sirolimus Topical Gel Available for Facial Angiofibroma Associated With Tuberous Sclerosis Complex
• FDA Lifts Hold on Phase 2 Trial of SRP-5051 in DMD Amenable to Exon 51 Skipping
• Philips Respironics Recalls Masks for BPAP and CPAP Machines After Safety Concerns
• FDA Advisory Committee Votes to Recommend AMX0035 for Treatment of ALS

• 1:15 – Current conversations around school start times and sleep
• 5:25 – The role of virtual schooling in helping sleep
• 9:00 – Education about sleep for children, parents, and professionals
• 13:15 – The current trends in sleep-focused behaviors 
• 14:30 – The prevalence and awareness of pediatric sleep disorders
• 16:35 – Neurology News Minute
• 19:30 – Improving sleep evaluation in daily clinical practice
• 24:00 – The trends in sleep medicine
• 26:30 – Leveraging the inherent attractiveness of sleep conversations
• 27:00 – Tips for the clinical community and self-advocacy

• Two Patient Deaths Reported With Zolgensma Administration in SMA
• Passage Bio Doses First Patient in Frontotemporal Dementia Gene Therapy Trial
• BLA Application to Be Submitted for ALS Agent NurOwn Following Phase 3 Statistical Corrections
• Jazz Initiates Trial Assessing Cannabidiol in Epilepsy With Myoclonic-Atonic Seizures

• CDC – Acute Flaccid Myelitis
• SRNA – Acute Flaccid Myelitis

• 1:15 – Background on AFM from the neurology perspective
• 3:50 – Background on AFM from the infectious disease perspective
• 6:10 – Ongoing work and research into AFM cases
• 9:15 – The evolution of the clinical care of patients with AFM
• 13:00 – The diagnostic approach and guidelines for AFM
• 16:05 – Neurology News Minute
• 19:00 – State of care and treatment approaches
• 21:45 – The importance of recognition of AFM
• 26:50 – Testing and differential diagnosis of AFM
• 32:30 – Message for the clinical community around awareness

• Significant Correlations Identified Between Mental Health and Migraine
• FDA Issues Second CRL for Pimavanserin, Now for the Treatment of Alzheimer Disease Psychosis
• ICER Releases Report Comparing Cost-Effectiveness of ALS Agents Oral Edaravone and AMX0035
• FDA Extends Review of Omaveloxolone in Friedreich Ataxia

• Multiple Sclerosis DMT Waste Is Staggering, New Study Shows
• Wasted DMTs in Dr. Okuda's office [Image]

• 1:45 – Background on the study conducted by Okuda et al.
• 4:05 – Perspective on the cost driven by DMT waste 
• 6:30 – Current landscape of prescriptions and adherence in MS
• 8:35 – Disparities in MS treatment adherence
• 11:00 – The link to the physician-patient relationship
• 16:40 – The process of choosing a DMT and shared decision-making 
• 23:00 – Neurology News Minute
• 25:45 – Finding solutions to the DMT waste problem
• 33:40 – The role of the individual neurologist and patient
• 38:30 – Access to specialist care and resources
• 42:40 – Building trust with patients and general medical mistrust
• 47:00 – Next steps and closing thoughts

• Zonisamide Oral Suspension FDA-Approved for Partial Seizures in Epilepsy
• FT218 Receives Tentative Approval for EDS, Cataplexy in Adults With Narcolepsy
• FDA Clears Rapid Hyperdensity Tool for Inclusion in RapidAI Platform for Neurovascular Conditions
• ALS Therapy Tofersen Has NDA Accepted by FDA, Granted Priority Review

• 1:25 – Overview of the current state of essential tremor care
• 7:05 – Changes in thinking about essential tremor
• 9:05 – Potential in the therapeutics pipeline
• 10:45 – Advances in the understanding of essential tremor
• 12:40 – Neurology News Minute
• 15:30 – The role of shared decision-making in care
• 18:50 – Surgical options for essential tremor treatment
• 22:00 – Education and diagnosis outside of movement specialists
• 24:00 – Advances on the horizon

• Biogen, Alectos Announce Licensing Agreement for Parkinson Disease GBA2 Inhibitor AL01811
• FDA Advisory Committee Agrees to Reconvene for Decision on ALS Treatment AMX0035
• FDA Accepts BLA for Lecanemab in Alzheimer Disease, Sets PDUFA Date for January 2023
• FDA Places Clinical Hold on Phase 2/3 ReMEDy2 Trial of DM199 in Acute Ischemic Stroke

• 1:25 – Overview of systematic review of depressive and anxiety symptoms in pediatric migraine
• 5:30 – Clinical implications of the data and the need for advocacy for this population
• 8:50 – Possible differences between children and adolescents
• 10:15 – Remaining questions for this area of research
• 13:20 – The needs from a research funding perspective
• 15:05 – Neurology News Minute
• 17:20 – Shifting the paradigm of pediatric headache research
• 21:35 – Challenges in awareness despite patient population size
• 24:15 – Exposure to headache medicine education among trainees
• 26:25 – Conducting clinical trials in pediatric migraine

• FDA Advisory Committee Votes Down Pimavanserin's Efficacy in AD Psychosis Ahead of PDUFA
• Parkinson Disease Symptom Data Tool StrivePD Receives FDA Clearance
• AbbVie Submits Supplemental New Drug Application for Atogepant in Chronic Migraine
• FDA Places Clinical Hold on Duchenne Muscular Dystrophy Drug SRP-5051 Amid Safety Concerns
• FDA Pauses Tolebrutinib Trials in MS, Myasthenia Gravis Over Liver Injuries

• Afsara Zaheed, graduate student, University of Michigan
• Richard Bogan, MD, FCCP, FAASM, associate clinical professor, University of South Carolina School of Medicine, and associate clinical professor, Medical University of South Carolina
• Ruth Benca, MD, PhD, professor and chair, Psychiatry & Human Behavior, Wake Forest School of Medicine

• 1:30 – Afsara Zaheed on the longitudinal patterns of difficulties initiating sleep, the associations with subsequent memory trajectories, and whether associations differ across non-Hispanic Black and White men and women.
• 6:00 – Richard Bogan, MD, FCCP, FAASM, on two post hoc analyses that explored treatment response for low-sodium oxybate based on the 14-item Idiopathic Hypersomnia Severity Scale and the 8-item, self-reported Epworth Sleepiness Scale.
• 12:05 – Ruth Benca, MD, PhD, on the precursor sleep issues to Alzheimer disease, the differences in sex and race, and the critical need to treat sleep disorders early as possible.

• Riley Bove, MD
• Blake E. Dewey, PhD
• Bruce Cree, MD, PhD, MAS
• John DeLuca, PhD
• Shuvro Roy, MD
• Tanuja Chitnis, MD

• 2:00 – Riley Bove, MD, on the conversations that women with multiple sclerosis have about disease-modifying therapies on social media platforms.
• 5:10 – Blake Dewey, PhD, on the efforts to improve the uptake in the use of spinal cord atrophy as a marker of disease progression.
• 8:45 – Bruce Cree, MD, PhD, MAS, on the latest data from the N-MOmemtum study in neuromyelitis optica spectrum disorder.
• 13:05 – John DeLuca, PhD, on the importance of measuring cognition longitudinally in patients with multiple sclerosis.
• 17:10 – Shuvro Roy, MD, on how the MS Smartform might be able to save physicians time in reviewing complex patient histories.
• 20:30 – Tanuja Chitnis, MD, on the use of foralumab in an older patient with nonactive secondary progressive multiple sclerosis.

• 2:05 – Major progress in ALS in recent years
• 4:35 – Key steps forward in genetic testing
• 7:25 – The understanding of genetics in ALS
• 9:20 – The role of databases in the care paradigm
• 11:35 – Neurology News Minute
• 15:25 – Advocacy's role in the last decade
• 18:40 – The state of clinical trials for ALS
• 20:40 – The pipeline of therapies and the future of treatment
• 24:50 – Importance of continued advocacy for ALS

• National Institutes of Health Launches Phase 1 Trial to Study Epstein-Barr Virus Vaccine
• Eisai Completes Rolling BLA Submission for Lecanemab to Treat MCI, Alzheimer Disease
• FDA Approves Oral Version of Edaravone for ALS

• 1:25 – Migraine highlights from the 2022 AAN Annual Meeting.
• 5:00 – Atogepant post hoc analyses showing dose-dependent weight loss.
• 9:25 – Rimegepant data and optimizing available treatments for quality of life.
• 12:50 – Current day-to-day challenges in migraine care.
• 15:10 – Neurology News Minute
• 18:50 – Progress made toward increasing migraine training and education.
• 22:45 – Other specialty's understanding of the migraine population.
• 27:35 – The importance of behavioral interventions in migraine.
• 32:05 – Looking ahead to the future of care.

• Axsome Issued CRL for AXS-07 in Acute Migraine Treatment
• FDA Approves Ravulizumab for Adults With Generalized Myasthenia Gravis
• FDA Permits Marketing for Plaque-Detecting Diagnostic Test for Alzheimer Disease

• 3:15 – Background on the new ATMRD Congress.
• 6:20 – Rates of adoption of novel therapeutics for Parkinson disease.
• 9:35 – What attendees should expect from the Congress this year.
• 11:20 – The need for a multidisciplinary approach to movement disorders and the multidisciplinary features of the Congress.
• 12:35 – Neurology News Minute
• 16:30 – Education and understanding about the optimal utilization of advanced therapies in Parkinson disease.
• 19:10 – Ongoing trends and conversations in the movement disorder field.
• 21:30 – Closing thoughts.

• FDA Approves Boston Scientific’s STIMVIEW XT Guided Imaging Software for DBS
• FDA Extends Review of Vutrisiran for ATTR Amyloidosis 3 Months, Now Expected in July 2022
• Higher-dose Erenumab Shows Better Prevention of Progression, Rationale Provided for Initiation at High Dose

• Jennifer Frontera, MD
• Stephen Krieger, MD
• Peter McAllister, MD
• Kelly Knupp, MD, MSCS
• Bruce Cree, MD, PhD, MAS
• Shrujal Baxi, MD, MPH
• Indu Subramanian, MD.

• 1:50 – Jennifer Frontera, MD, on the long-term data collected on COVID-19 post-infection neurological sequelae.
• 9:55 – Stephen Krieger, MD, on the trends in thinking about multiple sclerosis pathogenesis and quality of life.
• 14:05 – Peter McAllister, MD, on the phase 2 STEMTRA trial of stem cell therapy in patients with traumatic brain injury.
• 16:45 – Kelly Knupp, MD, MSCS, on the long-term use of fenfluramine in Lennox-Gastaut syndrome and clinical pearls on titration.
• 19:00 – Bruce Cree, MD, PhD, MAS, on the effect of inebilizumab in patients with neuromyelitis optica spectrum disorder regardless of disease duration.
• 21:05 – Shrujal Baxi, MD, MPH, on the AAN's Axon Registry and how Verana Health is playing a role in data collection.
• 23:55 – Indu Subramanian, MD, on the effects of COVID-19 on physicians and clinicians and the difficulties that have challenged the field.

For more of NeurologyLive®'s coverage of ganaxolone's approval, head here: Ganaxolone Wins Landmark Approval for CDKL5 Deficiency Disorder. For more of NeurologyLive®'s coverage of fenfluramine's approval, head here: Fenfluramine FDA-Approved for Treatment of Lennox-Gastaut Syndrome.

• 0:30 – Ganaxolone (Ztalmy; Marinus) approved for CDD
• 2:30 – Scott Demarest, MD, with his reaction to the approval
• 3:00 – Data from the Marigold study of ganaxolone
• 4:45 – Safety profile of ganaxolone in development
• 5:10 – Demarest on the landscape of care for CDD
• 6:20 – Clinical takeaways ahead of DEA scheduling for ganaxolone
• 8:40 – Fenfluramine (Fintepla; Zogenix/UCB) approved for LGS
• 10:55 – Kelly Knupp, MD, with her reaction to the new indication
• 11:30 – Efficacy data on fenfluramine in LGS
• 13:50 – Safety profile in LGS and Dravet syndrome
• 16:05 – Knupp on the potential to improve quality of life and optimal use

• 2:00 – State of diagnosis and care for NMOSD and similar disorders
• 6:00 – Role of NMOSD Awareness Month and advocacy efforts
• 8:45 – Current challenges with symptomatic management
• 11:20 – Multidisciplinary communication, coordination, and collaboration
• 13:05 – Neurology News Minute
• 16:45 – The potential of self-tolerization and curing NMOSD
• 19:05 – Nonpharmacologic approaches to care
• 20:40 – The need to improve physician awareness and education
• 22:45 – Advice for communicating the diagnosis to patients
• 24:45 – The need for patient advocacy groups

• Donepezil Transdermal System Wins FDA Approval to Treat Alzheimer Disease Dementia
• Sarepta Details Phase 3 EMBARK Study in DMD
• Ganaxolone Wins Landmark Approval for CDKL5 Deficiency Disorder

• 1:40 – Overview of narcolepsy
• 5:00 – Manifestation of narcolepsy and misdiagnosis rates
• 8:35 – Link between cardiovascular health and narcolepsy
• 12:10 – Tips to improve healthier behavioral habits
• 16:10 – Resources for physicians

• 1:30 – AASM's position statement on daylight saving time
• 3:15 – The impact of daylight saving time on circadian rhythm
• 5:30 – Patient education on sleep and daylight saving
• 6:40 – What can be learned from similar attempts to address sleep issues
• 10:00 – Evidence in favor of fixed-standard time
• 11:45 – Neurology News Minute
• 14:50 – The state of sleep in the US
• 19:15 – Physicians' relationship with sleep education
• 23:20 – Importance of World Sleep Day and awareness
• 25:30 – Advice for inquiring about patient sleep

• Roche Announces Phase 3 SKYLINE Trial of Gantenerumab in Alzheimer Disease
• FDA Approves Saluda’s Evoke Spinal Cord Stimulation System for Chronic Intractable Pain
• IND Application Accepted for Phase 2b Trial of NOE-101 in Trigeminal Neuralgia

• 1:25 – Background on Prime PD
• 5:00 – The digital wellness studio's programs for PD
• 9:20 – Future aims for additional disease states
• 12:00 – Neurology News Minute
• 14:20 – Potential to incorporate advanced practice clinicians and specialists
• 17:15 – Feedback from patients and physicians
• 22:30 – How physicians can get involved and/or utilize Prime PD

• High-Dose ACI-35.030 Shows Positive Phase 1b/2a Interim Data as Alzheimer Vaccine
• Acadia Resubmits sNDA for Pimavanserin to Treat Alzheimer Disease Psychosis
• Tolebrutinib Shows Favorable Long-Term Safety, Efficacy in Relapsing MS Open-Label Extension