Weekly Recap

ND0612 Receives Complete Letter Response, Otsuka Terminates AVP-786, TSHA-102 Performs in Phase 1/2 REVEAL Studies

ByNeurologyLive® Staff

June 23rd 2024

Neurology News Network. for the week ending June 22, 2024. [WATCH TIME: 4 minutes]

CIFFREO Study Fails Primary End Point, Gene Therapy for Duchenne Shows Promise, Deflazacort Generic Approved by FDA

ByNeurologyLive® Staff

June 16th 2024

Neurology News Network. for the week ending June 15, 2024. [WATCH TIME: 4 minutes]

EU Approves Tofersen for SOD1 ALS, SynAIRgy Study Aims to Change OSA Treatment, FDA Approves New Dosing for Amifampridine

ByNeurologyLive® Staff

June 9th 2024

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

APN-1607 Gets Fast Track Designation, ALS Agent BIIB105 Terminated, ION582 Safe in Angelman Syndrome

ByNeurologyLive® Staff

May 25th 2024

Neurology News Network. for the week ending May 25, 2024. [WATCH TIME: 4 minutes]

Dosing Commenced in Study of Anti-Tau Agent, FDA Updates Labeling to Glatiramer Acetate Products, Eisai Initiates Rolling Submission for Subcutaneous Lecanemab

ByNeurologyLive® Staff

May 18th 2024

Neurology News Network. for the week ending May 18, 2024. [WATCH TIME: 4 minutes]

PrimeC Performs Well in High-Risk ALS, Patient Death Reported in DAYLIGHT Trial, Donanemab AdComm Hearing Date Announced

ByNeurologyLive® Staff

May 11th 2024

Neurology News Network. for the week ending May 11, 2024. [WATCH TIME: 4 minutes]

ALZ-801 Enters Open-Label Studies, Subcutaneous Ocrelizumab Gets Positive EU Recommendation, FDA Approves Sprinkle Formulation of Valbenazine

ByNeurologyLive® Staff

May 4th 2024

Neurology News Network. for the week ending May 4, 2024. [WATCH TIME: 3 minutes]

SAGE-718 Fails Phase 2 Study, Foralumab Dampens Microglial Activation, MDA and FARA Collaborate on Gene Therapy Studies

ByNeurologyLive® Staff

April 27th 2024

Neurology News Network. for the week ending April 27, 2024. [WATCH TIME: 3 minutes]

Lecanemab ARIA Rates Unaffected by Centiloid Level, AB-1005 Meets Primary End Point, Fremanezumab Safe in Obese Patients With Migraine

ByNeurologyLive® Staff

April 20th 2024

Neurology News Network. for the week ending April 20, 2024. [WATCH TIME: 3 minutes]

Cenobamate Gets New Approved Administration Routes, FDA Agrees to New Trial Design for NurOwn, ENRICH Results Published in NEJM

ByNeurologyLive® Staff

April 13th 2024

Neurology News Network. for the week ending April 13, 2024. [WATCH TIME: 3 minutes]

Amylyx Pulls ALS Drug AMX0035, Gene Therapy Shows Promise in Giant Axonal Neuropathy, Eisai Submits sBLA for New Lecanemab Dosing

ByNeurologyLive® Staff

April 6th 2024

Neurology News Network. for the week ending April 6, 2024. [WATCH TIME: 3 minutes]

NeuroVoices: Francesco Saccà, MD, PhD, on Crossing Over Dimethyl Fumarate in Friedriech Ataxia

ByMarco Meglio

April 3rd 2024

The associate professor of neurology at the University of Naples discussed a recently enrolled study assessing the use of dimethyl fumarate, an approved therapy for relapsing MS and psoriasis, in patients with Friedreich ataxia.

STK-001 Shows Disease-Modifying Impacts in Dravet, FDA Approves Ravulizumab, Satralizumab Falls Short in Myasthenia Gravis

ByNeurologyLive® Staff

March 30th 2024

Neurology News Network. for the week ending March 30, 2024. [WATCH TIME: 3 minutes]

SLS-005 Performs Better Without AMX0035, Nerivio Gains Commercial Coverage, UB-312 Reduces α-Synuclein

ByNeurologyLive® Staff

March 23rd 2024

Neurology News Network for the week ending March 23, 2024. [WATCH TIME: 3 minutes]

Positive Phase 1 Study of Monepantel, CRL Given to GA Depot, FDA Rejects Tasimelteon sNDA

ByNeurologyLive® Staff

March 16th 2024

Neurology News Network for the week ending March 16, 2024. [WATCH TIME: 3 minutes]

EPIDYS Trial Supports Givinostat's Efficay, SRP-9001 in EMBARK Study, Eteplirsen Shows Long-Term Safety

ByNeurologyLive® Staff

March 9th 2024

Neurology News Network for the week ending March 9, 2024. [WATCH TIME: 3 minutes]

ATH-1105 Shows Promise as ALS Treatment, Eplontersen Granted Fast Track for ATTR Cardiomyopathy, Poor Oral Health Linked to Brain Profiles

ByNeurologyLive® Staff

March 2nd 2024

Neurology News Network for the week ending March 1, 2024. [WATCH TIME: 3 minutes]

CGRP and Gepant Combination Safe, DNL788 Fails ALS Study, Frexalimab Promising Phase 2 Results in Relapsing MS

ByNeurologyLive® Staff

February 24th 2024

Neurology News Network for the week ending February 24, 2024. [WATCH TIME: 3 minutes]

Laquinimod Reduces Caudate Volume in Huntington, Assisted Reproductive Technologies Increase In-Hospital Stroke Risk, Omaveloxolone Approved in EU

ByNeurologyLive® Staff

February 17th 2024

Neurology News Network for the week ending February 17, 2024. [WATCH TIME: 3 minutes]

Adrenomedullin Safe in Ischemic Stroke, NfL and GFAP Levels Identified During Stroke, Fibrinogenase Improves Functional Outcomes

ByNeurologyLive® Staff

February 10th 2024

Neurology News Network for the week ending February 10, 2024. [WATCH TIME: 3 minutes]

Biogen Discontinues Aducanumab, CHMP Issues Negative Opinion on Ataluren, SRP-5051 Shines in MOMENTUM Study

ByNeurologyLive® Staff

February 3rd 2024

Neurology News Network for the week ending February 3, 2024. [WATCH TIME: 3 minutes]

Cell Therapy HLCM051 Falls Short in Stroke Study, Benefits of Light Therapy in Alzheimer, IPL344 Phase 2a Data Released

ByNeurologyLive® Staff

January 27th 2024

Neurology News Network for the week ending January 27, 2024. [WATCH TIME: 3 minutes]

ALS Agent PrimeC Moves to Phase 3, FDA Clears IND for AB126, APOE Carrier Status Impacts ARIA

ByNeurologyLive® Staff

January 20th 2024

Neurology News Network for the week ending January 21, 2024. [WATCH TIME: 3 minutes]

CBD Leads to Nonseizure Improvements, AbbVie Launches 24-Hour Levodopa Infusion in EU, CNM-Au8 Improves Visual Function and Cognition

ByMarco Meglio

January 13th 2024

Neurology News Network for the week ending January 13, 2024. [WATCH TIME: 4 minutes]

ALS Agent CNM-Au8 Reduces NfL, Positive CLEAR-MIND Results, Decreased Learning Abilities in Narcolepsy

ByNeurologyLive® Staff

January 6th 2024

Neurology News Network for the week ending January 6, 2023. [WATCH TIME: 3 minutes]

Trial of Ptau Therapy ACI-35.030 Launched, Positive Data on AMT-130 in Huntington Disease, CHMP Recommends EU Approval of Omeveloxolone

ByNeurologyLive® Staff

December 23rd 2023

Neurology News Network for the week ending December 23, 2023. [WATCH TIME: 4 minutes]

Topline Data on NE3017 Announced, Pitolisant Improves EDS in DM1, Nerivio Reduces Migraine Treatment Days

ByNeurologyLive® Staff

December 16th 2023

Neurology News Network for the week ending December 16, 2023. [WATCH TIME: 3 minutes]

Concomitant ASM Dosages With Stiripentol, FDA Pushes Givinostat Decision Back, Soticlestat Improves Caregiver Satisfaction

ByNeurologyLive® Staff

December 9th 2023

Neurology News Network for the week ending December 9, 2023. [WATCH TIME: 3 minutes]

Phase 2 Trial of Alzheimer Psychosis Initiated, FDA Declines to Lift Hold on ENTR-601-44, Levetiracetam and Clobazam With Safety Warnings

ByNeurologyLive® Staff

December 2nd 2023

Neurology News Network for the week ending December 1, 2023. [WATCH TIME: 4 minutes]

FDA Grants BrainStorm Meeting for NurOwn, Gene Therapy Study of AB-1005 Underway, VISION Trial to Test DBS Enhancement in PD

ByNeurologyLive® Staff

November 25th 2023

Neurology News Network for the week ending November 25, 2023. [WATCH TIME: 4 minutes

Weekly Recap

ND0612 Receives Complete Letter Response, Otsuka Terminates AVP-786, TSHA-102 Performs in Phase 1/2 REVEAL Studies

CIFFREO Study Fails Primary End Point, Gene Therapy for Duchenne Shows Promise, Deflazacort Generic Approved by FDA

EU Approves Tofersen for SOD1 ALS, SynAIRgy Study Aims to Change OSA Treatment, FDA Approves New Dosing for Amifampridine

APN-1607 Gets Fast Track Designation, ALS Agent BIIB105 Terminated, ION582 Safe in Angelman Syndrome

Dosing Commenced in Study of Anti-Tau Agent, FDA Updates Labeling to Glatiramer Acetate Products, Eisai Initiates Rolling Submission for Subcutaneous Lecanemab

PrimeC Performs Well in High-Risk ALS, Patient Death Reported in DAYLIGHT Trial, Donanemab AdComm Hearing Date Announced

ALZ-801 Enters Open-Label Studies, Subcutaneous Ocrelizumab Gets Positive EU Recommendation, FDA Approves Sprinkle Formulation of Valbenazine

SAGE-718 Fails Phase 2 Study, Foralumab Dampens Microglial Activation, MDA and FARA Collaborate on Gene Therapy Studies

Lecanemab ARIA Rates Unaffected by Centiloid Level, AB-1005 Meets Primary End Point, Fremanezumab Safe in Obese Patients With Migraine

Cenobamate Gets New Approved Administration Routes, FDA Agrees to New Trial Design for NurOwn, ENRICH Results Published in NEJM

Amylyx Pulls ALS Drug AMX0035, Gene Therapy Shows Promise in Giant Axonal Neuropathy, Eisai Submits sBLA for New Lecanemab Dosing

NeuroVoices: Francesco Saccà, MD, PhD, on Crossing Over Dimethyl Fumarate in Friedriech Ataxia

STK-001 Shows Disease-Modifying Impacts in Dravet, FDA Approves Ravulizumab, Satralizumab Falls Short in Myasthenia Gravis

SLS-005 Performs Better Without AMX0035, Nerivio Gains Commercial Coverage, UB-312 Reduces α-Synuclein

Positive Phase 1 Study of Monepantel, CRL Given to GA Depot, FDA Rejects Tasimelteon sNDA

EPIDYS Trial Supports Givinostat's Efficay, SRP-9001 in EMBARK Study, Eteplirsen Shows Long-Term Safety

ATH-1105 Shows Promise as ALS Treatment, Eplontersen Granted Fast Track for ATTR Cardiomyopathy, Poor Oral Health Linked to Brain Profiles

CGRP and Gepant Combination Safe, DNL788 Fails ALS Study, Frexalimab Promising Phase 2 Results in Relapsing MS

Laquinimod Reduces Caudate Volume in Huntington, Assisted Reproductive Technologies Increase In-Hospital Stroke Risk, Omaveloxolone Approved in EU

Adrenomedullin Safe in Ischemic Stroke, NfL and GFAP Levels Identified During Stroke, Fibrinogenase Improves Functional Outcomes

Biogen Discontinues Aducanumab, CHMP Issues Negative Opinion on Ataluren, SRP-5051 Shines in MOMENTUM Study

Cell Therapy HLCM051 Falls Short in Stroke Study, Benefits of Light Therapy in Alzheimer, IPL344 Phase 2a Data Released

ALS Agent PrimeC Moves to Phase 3, FDA Clears IND for AB126, APOE Carrier Status Impacts ARIA

CBD Leads to Nonseizure Improvements, AbbVie Launches 24-Hour Levodopa Infusion in EU, CNM-Au8 Improves Visual Function and Cognition

ALS Agent CNM-Au8 Reduces NfL, Positive CLEAR-MIND Results, Decreased Learning Abilities in Narcolepsy

Trial of Ptau Therapy ACI-35.030 Launched, Positive Data on AMT-130 in Huntington Disease, CHMP Recommends EU Approval of Omeveloxolone

Topline Data on NE3017 Announced, Pitolisant Improves EDS in DM1, Nerivio Reduces Migraine Treatment Days

Concomitant ASM Dosages With Stiripentol, FDA Pushes Givinostat Decision Back, Soticlestat Improves Caregiver Satisfaction

Phase 2 Trial of Alzheimer Psychosis Initiated, FDA Declines to Lift Hold on ENTR-601-44, Levetiracetam and Clobazam With Safety Warnings

FDA Grants BrainStorm Meeting for NurOwn, Gene Therapy Study of AB-1005 Underway, VISION Trial to Test DBS Enhancement in PD

Trending on NeurologyLive

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

Expanding the Alzheimer Drug Development Pipeline

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

NeurologyLive® Friday 5 — September 12, 2025

FDA Hands Complete Response Letter to SL1009 for Pyruvate Dehydrogenase Complex Deficiency