Weekly Recap

NeurologyLive Weekly Recap

Each week on Saturday morning, the NeurologyLive^® team puts together a weekly recap that offers a quick look into some of the top headlines in neurology news that you may have missed.

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

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

NeurologyLive® Staff

Published: December 21st 2024 | Updated: 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

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

NeurologyLive® Staff

Published: December 7th 2024 | Updated: 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

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

NeurologyLive® Staff

Published: November 30th 2024 | Updated: 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

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

NeurologyLive® Staff

Published: November 23rd 2024 | Updated: 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

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

NeurologyLive® Staff

Published: November 16th 2024 | Updated: 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

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

NeurologyLive® Staff

Published: November 9th 2024 | Updated: November 9th 2024

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

Enhanced Dosing of Donanemab Lowers ARIA Risk, Anti-Tau Agent E2814 Shows Promising Results, Combination Approach of Intranasal Insulin and Empagliflozin

Enhanced Dosing of Donanemab Lowers ARIA Risk, Anti-Tau Agent E2814 Shows Promising Results, Combination Approach of Intranasal Insulin and Empagliflozin

NeurologyLive® Staff

Published: November 2nd 2024 | Updated: November 2nd 2024

Neurology News Network. for the week ending November 2, 2024. [WATCH TIME: 4 minutes]

Phase 3 Program of Vidofludimus Calcium Continues, CHMP Recommends Approval for Eplontersen, Patient Dosing Commenced in Phase 1/2 Trial of ATX-01

Phase 3 Program of Vidofludimus Calcium Continues, CHMP Recommends Approval for Eplontersen, Patient Dosing Commenced in Phase 1/2 Trial of ATX-01

NeurologyLive® Staff

Published: October 26th 2024 | Updated: October 26th 2024

Neurology News Network. for the week ending October 26, 2024. [WATCH TIME: 4 minutes]

FDA Approves Lumyrz for Pediatric Narcolepsy, 24-Hour Foslevodopa/Foscarbidopa Gets FDA Greenlight, Oral Edaravone Fails in Phase 3 Study

FDA Approves Lumyrz for Pediatric Narcolepsy, 24-Hour Foslevodopa/Foscarbidopa Gets FDA Greenlight, Oral Edaravone Fails in Phase 3 Study

NeurologyLive® Staff

Published: October 19th 2024 | Updated: October 19th 2024

Neurology News Network. for the week ending October 19, 2024. [WATCH TIME: 4 minutes]

HNSA-5487 Significantly Reduces IgG Levels, FDA Removes Hold on AOC 1001, DMD Gene Therapy Shows No Impact on Cardiac Outcomes

HNSA-5487 Significantly Reduces IgG Levels, FDA Removes Hold on AOC 1001, DMD Gene Therapy Shows No Impact on Cardiac Outcomes

NeurologyLive® Staff

Published: October 12th 2024 | Updated: September 28th 2024

Neurology News Network. for the week ending October 12, 2024. [WATCH TIME: 4 minutes]

Horizon Study Update for MSA Drug ION464, OnaboutlinumtoxinA to be Tested in Essential Tremor, Challenges With Ketogenic-Mediterranean Diets in PD

Horizon Study Update for MSA Drug ION464, OnaboutlinumtoxinA to be Tested in Essential Tremor, Challenges With Ketogenic-Mediterranean Diets in PD

NeurologyLive® Staff

Published: October 5th 2024 | Updated: September 28th 2024

Neurology News Network. for the week ending October 5, 2024. [WATCH TIME: 4 minutes]

Positive Phase 2 FORWARD-53 Data of WVE-N531, RNS60 Extends Survival in ALS, BLA to be Submitted for Deramiocel

Positive Phase 2 FORWARD-53 Data of WVE-N531, RNS60 Extends Survival in ALS, BLA to be Submitted for Deramiocel

NeurologyLive® Staff

Published: September 28th 2024 | Updated: September 28th 2024

Neurology News Network. for the week ending September 28, 2024. [WATCH TIME: 4 minutes]

New BREAKTHROUGH Study of BMB-101, Positive Phase 1 Data on Orexin Agonist ORX750, Dosing Commenced for QRL-101

New BREAKTHROUGH Study of BMB-101, Positive Phase 1 Data on Orexin Agonist ORX750, Dosing Commenced for QRL-101

NeurologyLive® Staff

Published: September 21st 2024 | Updated: September 21st 2024

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

FDA Supports A-Synuclein Assay for PD Trials, VES001 Meets Primary End Point, Digital Migraine Therapeutic CT-132 Performs

FDA Supports A-Synuclein Assay for PD Trials, VES001 Meets Primary End Point, Digital Migraine Therapeutic CT-132 Performs

NeurologyLive® Staff

Published: September 14th 2024 | Updated: September 14th 2024

Neurology News Network. for the week ending September 14, 2024. [WATCH TIME: 4 minutes]

Tolebrutinib Shows Promise in Non-Relapsing Secondary Progressive MS, Fenebrutinib Suppresses Relapses in New Data, FDA Accepts Resubmitted NDA for AXS-07

Tolebrutinib Shows Promise in Non-Relapsing Secondary Progressive MS, Fenebrutinib Suppresses Relapses in New Data, FDA Accepts Resubmitted NDA for AXS-07

NeurologyLive® Staff

Published: September 7th 2024 | Updated: September 7th 2024

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

AMX0035's Potential in Tauopathies, Alkermes Initiates Phase 2 Study of ALKS 2680, EryDex Falls Short in Phase 3 ATTeST Trial

AMX0035's Potential in Tauopathies, Alkermes Initiates Phase 2 Study of ALKS 2680, EryDex Falls Short in Phase 3 ATTeST Trial

NeurologyLive® Staff

Published: August 31st 2024 | Updated: August 31st 2024

Neurology News Network. for the week ending August 31, 2024. [WATCH TIME: 4 minutes]

Medtronic DBS Approved for Asleep Surgery, BHV-2100 Shows Early Promise, AOC 1044 Continues Dystrophin Production in Latest Update

Medtronic DBS Approved for Asleep Surgery, BHV-2100 Shows Early Promise, AOC 1044 Continues Dystrophin Production in Latest Update

NeurologyLive® Staff

Published: August 17th 2024 | Updated: August 17th 2024

Neurology News Network. for the week ending August 17, 2024. [WATCH TIME: 4 minutes]

IND Cleared for Cell Therapy in Progressive MS, FDA Approves IPX203, Migraine Treatment Nerivio Safe in Pediatric Populations

IND Cleared for Cell Therapy in Progressive MS, FDA Approves IPX203, Migraine Treatment Nerivio Safe in Pediatric Populations

NeurologyLive® Staff

Published: August 10th 2024 | Updated: August 10th 2024

Neurology News Network. for the week ending August 10, 2024. [WATCH TIME: 4 minutes]

ALPHA-1062 Approved for Alzheimer Disease, GLP-1 Agonist Shows Neuroprotective Effects Against Dementia, Lecanemab 3-Year Data Reported

ALPHA-1062 Approved for Alzheimer Disease, GLP-1 Agonist Shows Neuroprotective Effects Against Dementia, Lecanemab 3-Year Data Reported

NeurologyLive® Staff

Published: August 4th 2024 | Updated: August 4th 2024

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

Cerliponase Alfa Approved for All Ages of CLN2 Disease, SAGE-324 Discontinued, ION582 to Advance to Phase 3 in Angelman Syndrome

Cerliponase Alfa Approved for All Ages of CLN2 Disease, SAGE-324 Discontinued, ION582 to Advance to Phase 3 in Angelman Syndrome

NeurologyLive® Staff

Published: July 28th 2024 | Updated: June 24th 2024

Neurology News Network. for the week ending July 27, 2024. [WATCH TIME: 4 minutes]

LX2006 Improves Cardiac Biomarkers of FA, ATH434 Positive Results in MSA, Brivaracetam Effective Regardless of Intellectual Disabilities

LX2006 Improves Cardiac Biomarkers of FA, ATH434 Positive Results in MSA, Brivaracetam Effective Regardless of Intellectual Disabilities

NeurologyLive® Staff

Published: July 14th 2024 | Updated: June 24th 2024

Neurology News Network. for the week ending July 20, 2024. [WATCH TIME: 4 minutes]

SKY-0515 Shows Significant HTT Reduction, AMT-130 Slows Huntington Progression, Capricor to Meet With FDA on CAP-1002

SKY-0515 Shows Significant HTT Reduction, AMT-130 Slows Huntington Progression, Capricor to Meet With FDA on CAP-1002

NeurologyLive® Staff

Published: July 14th 2024 | Updated: June 24th 2024

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

AFFINITY DUCHENNE Trial Expands, Suvecaltamide Fails Phase 2b Study of Essential Tremor, PTC518 Shows Dose-Dependent Huntingtin Lowering

AFFINITY DUCHENNE Trial Expands, Suvecaltamide Fails Phase 2b Study of Essential Tremor, PTC518 Shows Dose-Dependent Huntingtin Lowering

NeurologyLive® Staff

Published: July 7th 2024 | Updated: June 24th 2024

Neurology News Network. for the week ending July 6, 2024. [WATCH TIME: 4 minutes]

ABBV-951 Gets Another CRL, Pitolisant Approved for Pediatric Narcolepsy, FDA Clears Efgartigimod for CIDP

ABBV-951 Gets Another CRL, Pitolisant Approved for Pediatric Narcolepsy, FDA Clears Efgartigimod for CIDP

NeurologyLive® Staff

Published: June 30th 2024 | Updated: June 24th 2024

Neurology News Network. for the week ending June 29, 2024. [WATCH TIME: 3 minutes]

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

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

NeurologyLive® Staff

Published: June 23rd 2024 | Updated: June 24th 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

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

NeurologyLive® Staff

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

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

NeurologyLive® Staff

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

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

NeurologyLive® Staff

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

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

NeurologyLive® Staff

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

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

NeurologyLive® Staff

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

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