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

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

NeurologyLive® Staff

Published: March 1st 2025 | Updated: 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

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

NeurologyLive® Staff

Published: February 22nd 2025 | Updated: 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

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

NeurologyLive® Staff

Published: February 16th 2025 | Updated: 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

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

NeurologyLive® Staff

Published: February 9th 2025 | Updated: 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

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

NeurologyLive® Staff

Published: February 2nd 2025 | Updated: 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

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

NeurologyLive® Staff

Published: January 25th 2025 | Updated: 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

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

NeurologyLive® Staff

Published: January 18th 2025 | Updated: January 4th 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

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

NeurologyLive® Staff

Published: January 11th 2025 | Updated: January 4th 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

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

NeurologyLive® Staff

Published: January 4th 2025 | Updated: 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

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]

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