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FDA Supports Alpha-Synuclein Seed Amplification Assay Biomarker for Clinical Trials in Parkinson Disease
The agency’s letter of support for using the α-synuclein seed amplification assay biomarker was supported by data observed in the Parkinson's Progression Markers Initiative cohort study.

Ashwini Sharan, MD, chief medical officer of Medtronic Neuromodulation, provided commentary on the FDA’s decision to approve asleep deep brain stimulation for the treatment of Parkinson disease and essential tremor.

Test your neurology knowledge with NeurologyLive®'s weekly quiz series, featuring questions on a variety of clinical and historical neurology topics. This week's topic is on essential tremor.

Tanya, a patient who lost her mobility due to undiagnosed spinal issues, discussed her life-saving surgery for spinal meningioma, and the complex surgical process she underwent to regain her strength.

Denali Therapeutics plans to seek accelerated FDA approval for DNL310 in Hunter syndrome, showing significant biomarker improvements and clinical benefits in ongoing trials.

Jim Cassidy, MD, PhD, chief medical officer at SpringWorks Therapeutics, talked about how the prioritization of mirdametinib, a promising treatment for both adult and pediatric patients with neurofibromatosis type 1-associated plexiform neurofibromas.

The application is based on results of Prilenia Therapeutics’ phase 3 study that assessed the safety and efficacy of pridopidine in patients with Huntington disease.

Here's some of what is coming soon to NeurologyLive® this week.

Mirdametinib, a treatment in development for adult and pediatric patients with neurofibromatosis type 1-associated plexiform neurofibromas, was granted a PDUFA target action date of February 28, 2025.

AMX0035's Potential in Tauopathies, Alkermes Initiates Phase 2 Study of ALKS 2680, EryDex Falls Short in Phase 3 ATTeST Trial
Neurology News Network. for the week ending August 31, 2024. [WATCH TIME: 4 minutes]

The FDA has granted fast track designation to [18F]PI-2620 for 3 neurodegenerative conditions, highlighting its potential to improve early diagnosis and treatment.

Phase 1b trials involving patients with Parkinson are planned for late 2024, with data expected by mid-2025.

Axon Guidance Pathway Proteins Identified as Potential Biomarkers for Progressive Supranuclear Palsy
Findings from a recent study analyzing 3 cohorts suggested that certain proteins in the cerebrospinal fluid may have potential as biomarkers or therapeutic targets in progressive supranuclear palsy.

EryDex did not meet its primary end point possibly because of delays in treatment reducing the number of patients who received the agent, and different treatment effects based on age.

Here's some of what is coming soon to NeurologyLive® this week.

DT-216P2 shows promise in treating patients with Friedreich ataxia based on positive phase 1 trial results that indicated a significant increase in frataxin mRNA levels.

A recent review showed different fluid biomarkers were involved in neurodegeneration, oxidative stress, metabolism, microRNA and novel genes in spinocerebellar ataxia type 3.

Significant Biomarker Changes Identified in Spinocerebellar Ataxia Type 2 and 7 Carriers Over 1 Year
Researchers detected annual changes in patients with preataxic and early ataxic spinocerebellar ataxia in brain MRI imaging, clinical scores, gait parameters, and retinal thickness.

According to a recent announcement, Larimar Therapeutics reported that all 7 sites of the open-label extension study were activated for assessing nomlabofusp in Friedreich ataxia.

Here's some of what is coming soon to NeurologyLive® this week.

Medtronic DBS Approved for Asleep Surgery, BHV-2100 Shows Early Promise, AOC 1044 Continues Dystrophin Production in Latest Update
Neurology News Network. for the week ending August 17, 2024. [WATCH TIME: 4 minutes]

The panelists provided clinical insight on the utilization of IPX203, its potential benefits and clinical implications, as well as the practicalities of transitioning patients from other therapies.

The panelists discussed the safety profile of IPX203, considering challenges with transitioning, dosing strategies, and monitoring and adjusting patients’ individual dosage.

Dr. Hauser and Dr. Fernandez provided insight on the body of supportive evidence for IPX203, the notable takeaways from RISE-PD, and the long-term benefits observed from treated patients.

IPX203 combines immediate and extended-release levodopa, utilizing advanced delivery technology to optimize absorption and prolong therapeutic effects in patients with Parkinson disease.






















