Weekly Recap

FDA Fast Tracks Etalanetug, Encouraging Interim TEMPO-4 Data, Initial Data on Cell Therapy UX-DA001

ByNeurologyLive® Staff

October 25th 2025

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

Elecsys pTau181 Test Cleared, Tividenofusp Alfa PDUFA Pushed Back, Phase 4 LOTUS Study Highlights Real-World Benefit of Trofinetide

ByNeurologyLive® Staff

October 18th 2025

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

36-Month Data on Bemdaneprocel, Ravulizimab Shines in CHAMPION-NMOSD Trial, FDA Fast Tracks Anti-MBTR Tau Antibody

ByNeurologyLive® Staff

October 11th 2025

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

Updated NMOSD Diagnostic Criteria, Tavapadon NDA Submitted, MIL-62 Shows Promising Treatment Effects in NMOSD

ByNeurologyLive® Staff

October 4th 2025

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

High Dose Nusinersen, Apitegromab Receive CRLs, Tolebrutinib PDUFA Pushed Back

ByNeurologyLive® Staff

September 27th 2025

Neurology News Network. for the week ending September 27, 2025. [WATCH TIME: 4 minutes]

DORAs Carry Lower Real-World Abuse, New Phase 3 Argus Data, RAP-219 Meets Primary End Point

ByNeurologyLive® Staff

September 13th 2025

Neurology News Network. for the week ending September 13, 2025. [WATCH TIME: 4 minutes]

Efgartigimod Meets End Point in Seronegative Myasthenia Gravis Study, Cemdisiran Submission for MG Coming Soon, Phase 3 Studies of IncobotulinumtoxinA Begin

ByNeurologyLive® Staff

August 30th 2025

Neurology News Network. for the week ending August 30, 2025. [WATCH TIME: 4 minutes]

Vatiquinone Recieves CRL, RAINBOWFISH Study Published in NEJM, Hearing Aids Show Protective Effects Against Dementia

ByNeurologyLive® Staff

August 23rd 2025

Neurology News Network. for the week ending August 23, 2025. [WATCH TIME: 4 minutes]

Vormatrigine Reduces Seizures in Phase 2 RADIANT Study, Postpartum Depression in MS Women, Ianalumab Produces Significant Phase 3 Data in Sjögren’s disease

ByNeurologyLive® Staff

August 16th 2025

Neurology News Network. for the week ending August 16, 2025. [WATCH TIME: 4 minutes]

Elecsys Blood Test Gains EU Approval, FDA Expands Fremanezumab Indication Into Pediatrics, VX-993 Fails Phase 2 Pain Trial

ByNeurologyLive® Staff

August 9th 2025

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

IHL-42X Performs in Phase 2 RePOSA Study, ATH434 Eyes Phase 3 Multiple System Atrophy Trial, 4-Year Data on Lecanemab Unveiled

ByNeurologyLive® Staff

August 2nd 2025

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

Gefurulimab Positive Phase 3 Data Released, PoNS Device Eyes Stroke Indication, AD109 Performs in Phase 3 LunAIRo Trial

ByNeurologyLive® Staff

July 26th 2025

Neurology News Network. for the week ending July 26, 2025. [WATCH TIME: 4 minutes]

Sleep Agent Oveporexton Meets End Points in Phase 3 Studies, XPro Shows Mixed Phase 2 Data, Ultraprocessed Food Consumption Linked to Parkinson's Features

ByNeurologyLive® Staff

July 19th 2025

Neurology News Network. for the week ending July 19, 2025. [WATCH TIME: 4 minutes]

FDA Approves Updated Donanemab Labeling, BLA Accepted for Tividenofusp Alfa, Nipocalimab Outperforms FcRn Blockers

ByNeurologyLive® Staff

July 12th 2025

Neurology News Network. for the week ending July 12, 2025. [WATCH TIME: 4 minutes]

Salanersen Shows Promise in Phase 1, MESA Open-Label Data Released, Fenfluramine Meets End Points in Phase 3 GEMZ Trial

ByNeurologyLive® Staff

July 5th 2025

Neurology News Network. for the week ending July 5, 2025. [WATCH TIME: 4 minutes]

Eptinezumab Improves Medication Overuse Headache, Submission for GTx-104 in Subarachnoid Hemorrhage, FDA Expands Indication for Vizamyl PET Imaging

ByNeurologyLive® Staff

June 28th 2025

Neurology News Network. for the week ending June 28, 2025. [WATCH TIME: 4 minutes]

Atogepant Outperforms Topiramate, IND Accepted for ORX142, Prasinezumab Heads to Phase 3 Parkinson Disease Studies

ByNeurologyLive® Staff

June 21st 2025

Neurology News Network. for the week ending June 21, 2025. [WATCH TIME: 4 minutes]

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]

Weekly Recap

FDA Fast Tracks Etalanetug, Encouraging Interim TEMPO-4 Data, Initial Data on Cell Therapy UX-DA001

Elecsys pTau181 Test Cleared, Tividenofusp Alfa PDUFA Pushed Back, Phase 4 LOTUS Study Highlights Real-World Benefit of Trofinetide

36-Month Data on Bemdaneprocel, Ravulizimab Shines in CHAMPION-NMOSD Trial, FDA Fast Tracks Anti-MBTR Tau Antibody

Updated NMOSD Diagnostic Criteria, Tavapadon NDA Submitted, MIL-62 Shows Promising Treatment Effects in NMOSD

High Dose Nusinersen, Apitegromab Receive CRLs, Tolebrutinib PDUFA Pushed Back

DORAs Carry Lower Real-World Abuse, New Phase 3 Argus Data, RAP-219 Meets Primary End Point

Efgartigimod Meets End Point in Seronegative Myasthenia Gravis Study, Cemdisiran Submission for MG Coming Soon, Phase 3 Studies of IncobotulinumtoxinA Begin

Vatiquinone Recieves CRL, RAINBOWFISH Study Published in NEJM, Hearing Aids Show Protective Effects Against Dementia

Vormatrigine Reduces Seizures in Phase 2 RADIANT Study, Postpartum Depression in MS Women, Ianalumab Produces Significant Phase 3 Data in Sjögren’s disease

Elecsys Blood Test Gains EU Approval, FDA Expands Fremanezumab Indication Into Pediatrics, VX-993 Fails Phase 2 Pain Trial

IHL-42X Performs in Phase 2 RePOSA Study, ATH434 Eyes Phase 3 Multiple System Atrophy Trial, 4-Year Data on Lecanemab Unveiled

Gefurulimab Positive Phase 3 Data Released, PoNS Device Eyes Stroke Indication, AD109 Performs in Phase 3 LunAIRo Trial

Sleep Agent Oveporexton Meets End Points in Phase 3 Studies, XPro Shows Mixed Phase 2 Data, Ultraprocessed Food Consumption Linked to Parkinson's Features

FDA Approves Updated Donanemab Labeling, BLA Accepted for Tividenofusp Alfa, Nipocalimab Outperforms FcRn Blockers

Salanersen Shows Promise in Phase 1, MESA Open-Label Data Released, Fenfluramine Meets End Points in Phase 3 GEMZ Trial

Eptinezumab Improves Medication Overuse Headache, Submission for GTx-104 in Subarachnoid Hemorrhage, FDA Expands Indication for Vizamyl PET Imaging

Atogepant Outperforms Topiramate, IND Accepted for ORX142, Prasinezumab Heads to Phase 3 Parkinson Disease Studies

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

Trending on NeurologyLive - Clinical Neurology News and Neurology Expert Insights

FDA Fast Tracks Etalanetug, Encouraging Interim TEMPO-4 Data, Initial Data on Cell Therapy UX-DA001

Incidence and Prevalence of Frontotemporal Dementia Similar to Dementia with Lewy Bodies, Meta-Analysis Shows

Benzodiazepines and Antipsychotics Tied to Higher Mortality in Hospice Patients With Dementia

NeurologyLive® Friday 5 — October 24, 2025

Enhancing Stroke Systems of Care