Weekly Recap

Once-Nightly Oxybate Reduces Sleep-Related Eating, Samelisant Improves Excessive Daytime Sleepiness, Tirzepatide's Impact on OSA and Obesity

ByNeurologyLive® Staff

June 14th 2025

Neurology News Network. for the week ending June 14, 2025. [WATCH TIME: 4 minutes]

RGX-202 Shows Continued Promise in DMD, AJ201 Meets End Points in Spinal and Bulbar Muscular Atrophy, Ponesimod Effect Sustained Over Long-Term

ByNeurologyLive® Staff

June 7th 2025

Neurology News Network. for the week ending June 7, 2025. [WATCH TIME: 4 minutes]

ADDRESS-LC Study of Long COVID Initiated, Phase 4 Trial Testing IVIg Transition to Efgartigimod, Lack of Rebound Effect Seen in Ozanimod

ByNeurologyLive® Staff

May 31st 2025

Neurology News Network. for the week ending May 31, 2025. [WATCH TIME: 4 minutes]

Positive Phase 3 Data for Oral OSA Medication AD109, FDA Clears First Blood Test for Alzheimer Disease, DHE Autoinjector Treatment Approved for Migraine

ByNeurologyLive® Staff

May 24th 2025

Neurology News Network. for the week ending May 24, 2025. [WATCH TIME: 4 minutes]

AMX0035 Continues Promise in Wolfram Syndrome, FDA Clears Testing for CAP-002, Gene Therapy AAV-GAD Gains RMAT Designation

ByNeurologyLive® Staff

May 17th 2025

Neurology News Network. for the week ending May 10, 2025. [WATCH TIME: 4 minutes]

EAP Program Authorized for ALS Agent SPG302, PTC518 Meets Primary End Point, Capricor Completes Mid-Cycle Review for Deramiocel

ByNeurologyLive® Staff

May 10th 2025

Neurology News Network. for the week ending May 10, 2025. [WATCH TIME: 4 minutes]

FDA Approves STS101 for Acute Migraine, CALLIPER Trial Results Unveiled, Nipocalimab Gains FDA Approval for Myasthenia Gravis

ByNeurologyLive® Staff

May 3rd 2025

Neurology News Network. for the week ending May 3, 2025. [WATCH TIME: 3 minutes]

GENERATION HD2 Trial Amended, NeuroOne Completes Submission for OneRF Ablation System, FDA Authorizes Implantable Continuous EEG Monitoring System

ByNeurologyLive® Staff

April 26th 2025

Neurology News Network. for the week ending April 26, 2025. [WATCH TIME: 3 minutes]

Valtoco Gains Expanded Indication, FDA Approves Digital Therapeutic for Migraine, Phase 1 Study of AMX0114 in ALS Begins

ByNeurologyLive® Staff

April 19th 2025

Neurology News Network. for the week ending April 19, 2025. [WATCH TIME: 3 minutes]

Tividenofusp Alfa to be Submitted for Hunter Syndrome, Transcranial Stimulation Shows Efficacy in Alzheimer's, FDA Approves Pre-Filled Syringe for Efgartigimod

ByNeurologyLive® Staff

April 12th 2025

Neurology News Network. for the week ending April 12, 2025. [WATCH TIME: 3 minutes]

Gamma Sensory Stimulation Preserves Corpus Callosum, P-Tau 217 and 181 Correlate With Clinical Outcomes, Lecanemab ARIA Risk Highest in Elevated Aß42/Total Tau Ratios

ByNeurologyLive® Staff

April 5th 2025

Neurology News Network. for the week ending April 5, 2025. [WATCH TIME: 3 minutes]

HEALEY-ALS Platform Trial Amended, WVE-N531 Improves Muscle Growth in DMD, Diazoxide Choline Approved for Prader-Willi Syndrome

ByNeurologyLive® Staff

March 29th 2025

Neurology News Network. for the week ending March 29, 2025. [WATCH TIME: 3 minutes]

New Study Testing Omaveloxolone in Pregnant Patients, Rozanolixizumab Improves Ocular Symptoms, Efgartigimod to be Studied in Juvenile MG

ByNeurologyLive® Staff

March 22nd 2025

Neurology News Network. for the week ending March 22, 2025. [WATCH TIME: 3 minutes]

Neflamapimod RewinD-LB Extension Data, CHMP Reaffirms Lecanemab Stance, Donanemab Associated With Increased ARIA Risk

ByNeurologyLive® Staff

March 15th 2025

Neurology News Network. for the week ending March 15, 2025. [WATCH TIME: 3 minutes]

Pilavapadin Improves Diabetic Peripheral Neuropathic Pain, Application of 2025 McDonald Criteria, FDA Expands Eculizumab Indication to Pediatrics

ByNeurologyLive® Staff

March 8th 2025

Neurology News Network. for the week ending March 8, 2025. [WATCH TIME: 3 minutes]

FDA Approves Medtronic's Adaptive DBS, Hold Lifted on ELEVATE-44-102 Trial, Ecopipam Meets Primary and Secondary End Points in Tourette

ByNeurologyLive® Staff

March 1st 2025

Neurology News Network. for the week ending March 1, 2025. [WATCH TIME: 3 minutes]

Harmony Receives RTF Letter for Pitolisant, FDA Accepts Vatiquinone NDA, Gene Therapy SGT-003 Performs Well in Phase 1/2 Trial

ByNeurologyLive® Staff

February 22nd 2025

Neurology News Network. for the week ending February 23, 2025. [WATCH TIME: 3 minutes]

NDA Accepted for Troriluzole, FDA Approves Mirdametinib for Neurofibromatosis, New Tablet Formulation for Risdiplam Approved

ByNeurologyLive® Staff

February 16th 2025

Neurology News Network. for the week ending February 16, 2025. [WATCH TIME: 3 minutes]

Bexicaserin Improves Seizure Control in DEEs, SPN-830 Approved for Parkinson Disease, Self-Administration Rozanolixizumab Gains EU Approval

ByNeurologyLive® Staff

February 9th 2025

Neurology News Network. for the week ending February 9, 2025. [WATCH TIME: 4 minutes]

MSA Agent ATH434 Shows Promising Phase 2 Data, FDA Approves Suzetrigine for Severe Acute Pain, AXS-07 Gains FDA Approval for Migraine

ByNeurologyLive® Staff

February 2nd 2025

Neurology News Network. for the week ending February 2, 2025. [WATCH TIME: 4 minutes]

FDA Accepts sNDA for Higher Dose Nusinersen, Tofersen Demonstrates Real-World Efficacy, Nipocalimab Gains Priority Review

ByNeurologyLive® Staff

January 25th 2025

Neurology News Network. for the week ending January 25, 2025. [WATCH TIME: 4 minutes]

FDA Accepts NDA for Lecanemab Subcutaneous Autoinjector, RAP-219 Shows Promise in Early Trials, Blarcamesine Treatment Effects Observed at 3 Years

ByNeurologyLive® Staff

January 18th 2025

Neurology News Network. for the week ending January 18, 2025. [WATCH TIME: 4 minutes]

Anti-Tau Therapy Posdinemab Gets Fast Track, Gene Therapy SGT-212 to Enter Friedreich Ataxia Trial, Zorevunersen Eyes Phase 3 Trial of Dravet

ByNeurologyLive® Staff

January 11th 2025

Neurology News Network. for the week ending January 11, 2025. [WATCH TIME: 4 minutes]

Intrathecal Zolgensma Meets Primary End Point, Deramiocel BLA Submitted, Imlifidase Improves Function in Guillain-Barré Syndrome

ByNeurologyLive® Staff

January 4th 2025

Neurology News Network. for the week ending January 4, 2025. [WATCH TIME: 4 minutes]

FDA Places Hold on CONNECT2-EDO51, Sevasemten Meets End Point in Becker, Tolebrutinib Gets Breakthrough Therapy Designation

ByNeurologyLive® Staff

December 21st 2024

Neurology News Network. for the week ending December 21, 2024. [WATCH TIME: 4 minutes]

RELIEV2-CM Study Launched, Dose-Finding Portion of ANQUR Underway, Anavex Submits EU Application for Blarcamesine

ByNeurologyLive® Staff

December 7th 2024

Neurology News Network. for the week ending December 7, 2024. [WATCH TIME: 4 minutes]

Alzheimer Agent Simufilam Fails Phase 3, Lamotrigine Trial in DLB, Hearing Loss Independent Risk Factor for Parkinson

ByNeurologyLive® Staff

November 30th 2024

Neurology News Network. for the week ending November 30, 2024. [WATCH TIME: 4 minutes]

Parkinson Agent Solengepras Enters Phase 3, Sage to Discontinue SAGE-718, Serious Adverse Event Reported in Gene Therapy Study of NGN-401

ByNeurologyLive® Staff

November 23rd 2024

Neurology News Network. for the week ending November 23, 2024. [WATCH TIME: 4 minutes]

FDA Clears ARIA Detecting Software, Nerivio Gains Expanded Indication, FDA Approves First-Ever Gene Therapy for AADC Deficiency

ByNeurologyLive® Staff

November 16th 2024

Neurology News Network. for the week ending November 9, 2024. [WATCH TIME: 4 minutes]

FDA Places Hold on RAP-219, cAPPricorn-1 Study to Assess Mivelsiran in CAA, FDA Accepts Resubmitted NDA for Ataluren

ByNeurologyLive® Staff

November 9th 2024

Neurology News Network. for the week ending November 9, 2024. [WATCH TIME: 4 minutes]

Weekly Recap

Once-Nightly Oxybate Reduces Sleep-Related Eating, Samelisant Improves Excessive Daytime Sleepiness, Tirzepatide's Impact on OSA and Obesity

RGX-202 Shows Continued Promise in DMD, AJ201 Meets End Points in Spinal and Bulbar Muscular Atrophy, Ponesimod Effect Sustained Over Long-Term

ADDRESS-LC Study of Long COVID Initiated, Phase 4 Trial Testing IVIg Transition to Efgartigimod, Lack of Rebound Effect Seen in Ozanimod

Positive Phase 3 Data for Oral OSA Medication AD109, FDA Clears First Blood Test for Alzheimer Disease, DHE Autoinjector Treatment Approved for Migraine

AMX0035 Continues Promise in Wolfram Syndrome, FDA Clears Testing for CAP-002, Gene Therapy AAV-GAD Gains RMAT Designation

EAP Program Authorized for ALS Agent SPG302, PTC518 Meets Primary End Point, Capricor Completes Mid-Cycle Review for Deramiocel

FDA Approves STS101 for Acute Migraine, CALLIPER Trial Results Unveiled, Nipocalimab Gains FDA Approval for Myasthenia Gravis

GENERATION HD2 Trial Amended, NeuroOne Completes Submission for OneRF Ablation System, FDA Authorizes Implantable Continuous EEG Monitoring System

Valtoco Gains Expanded Indication, FDA Approves Digital Therapeutic for Migraine, Phase 1 Study of AMX0114 in ALS Begins

Tividenofusp Alfa to be Submitted for Hunter Syndrome, Transcranial Stimulation Shows Efficacy in Alzheimer's, FDA Approves Pre-Filled Syringe for Efgartigimod

Gamma Sensory Stimulation Preserves Corpus Callosum, P-Tau 217 and 181 Correlate With Clinical Outcomes, Lecanemab ARIA Risk Highest in Elevated Aß42/Total Tau Ratios

HEALEY-ALS Platform Trial Amended, WVE-N531 Improves Muscle Growth in DMD, Diazoxide Choline Approved for Prader-Willi Syndrome

New Study Testing Omaveloxolone in Pregnant Patients, Rozanolixizumab Improves Ocular Symptoms, Efgartigimod to be Studied in Juvenile MG

Neflamapimod RewinD-LB Extension Data, CHMP Reaffirms Lecanemab Stance, Donanemab Associated With Increased ARIA Risk

Pilavapadin Improves Diabetic Peripheral Neuropathic Pain, Application of 2025 McDonald Criteria, FDA Expands Eculizumab Indication to Pediatrics

FDA Approves Medtronic's Adaptive DBS, Hold Lifted on ELEVATE-44-102 Trial, Ecopipam Meets Primary and Secondary End Points in Tourette

Harmony Receives RTF Letter for Pitolisant, FDA Accepts Vatiquinone NDA, Gene Therapy SGT-003 Performs Well in Phase 1/2 Trial

NDA Accepted for Troriluzole, FDA Approves Mirdametinib for Neurofibromatosis, New Tablet Formulation for Risdiplam Approved

Bexicaserin Improves Seizure Control in DEEs, SPN-830 Approved for Parkinson Disease, Self-Administration Rozanolixizumab Gains EU Approval

MSA Agent ATH434 Shows Promising Phase 2 Data, FDA Approves Suzetrigine for Severe Acute Pain, AXS-07 Gains FDA Approval for Migraine

FDA Accepts sNDA for Higher Dose Nusinersen, Tofersen Demonstrates Real-World Efficacy, Nipocalimab Gains Priority Review

FDA Accepts NDA for Lecanemab Subcutaneous Autoinjector, RAP-219 Shows Promise in Early Trials, Blarcamesine Treatment Effects Observed at 3 Years

Anti-Tau Therapy Posdinemab Gets Fast Track, Gene Therapy SGT-212 to Enter Friedreich Ataxia Trial, Zorevunersen Eyes Phase 3 Trial of Dravet

Intrathecal Zolgensma Meets Primary End Point, Deramiocel BLA Submitted, Imlifidase Improves Function in Guillain-Barré Syndrome

FDA Places Hold on CONNECT2-EDO51, Sevasemten Meets End Point in Becker, Tolebrutinib Gets Breakthrough Therapy Designation

RELIEV2-CM Study Launched, Dose-Finding Portion of ANQUR Underway, Anavex Submits EU Application for Blarcamesine

Alzheimer Agent Simufilam Fails Phase 3, Lamotrigine Trial in DLB, Hearing Loss Independent Risk Factor for Parkinson

Parkinson Agent Solengepras Enters Phase 3, Sage to Discontinue SAGE-718, Serious Adverse Event Reported in Gene Therapy Study of NGN-401

FDA Clears ARIA Detecting Software, Nerivio Gains Expanded Indication, FDA Approves First-Ever Gene Therapy for AADC Deficiency

FDA Places Hold on RAP-219, cAPPricorn-1 Study to Assess Mivelsiran in CAA, FDA Accepts Resubmitted NDA for Ataluren

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