FDA Clears Brainstorm Cell Therapeutics' Phase 3b Trial of NurOwn for ALS Treatment
Brainstorm Cell Therapeutics has received FDA clearance to initiate a Phase 3b trial of NurOwn for the treatment of Amyotrophic Lateral Sclerosis (ALS), marking a significant advancement in their clinical development program.
BrainStorm Advances NurOwn ALS Therapy with FDA-Aligned Phase 3b Trial Submission
BrainStorm Cell Therapeutics has submitted an IND amendment to the FDA for NurOwn, its autologous mesenchymal stem cell therapy for ALS, setting the stage for a pivotal Phase 3b clinical trial.
FDA Clears BlackfinBio's Gene Therapy Trial for Rare Hereditary Spastic Paraplegia
The US FDA has approved BlackfinBio's investigational new drug application for BFB-101, an adeno-associated virus gene therapy targeting hereditary spastic paraplegia type 47 (SPG47).
Global Neuroregeneration Therapy Market Set to Reach $64.8 Billion by 2034, Driven by AI and Stem Cell Innovations
The neuroregeneration therapy market is projected to grow at a 5.3% CAGR from 2024 to 2034, with North America leading the expansion due to advanced healthcare infrastructure and strong research funding.
Gene and Cell Therapies Show Promise in Treating CNS Disorders
The market for gene and cell therapies targeting CNS disorders was valued at approximately USD 1 billion in 2021 and is projected to grow significantly by 2034.
BrainStorm's NurOwn Shows Positive Survival Data in ALS Expanded Access Program
BrainStorm Cell Therapeutics presented data from its NurOwn Expanded Access Program (EAP) at the 2024 NEALS meeting, showing potential long-term survival benefits for ALS patients.
BrainStorm Cell Therapeutics Announces Update on Phase 3b NurOwn Trial for ALS
BrainStorm Cell Therapeutics will provide an update on its Phase 3b clinical trial for NurOwn, an investigational cell therapy for amyotrophic lateral sclerosis (ALS).
ALS Clinical Trial Landscape: Investigational Therapies Targeting Sporadic ALS
Several clinical trials are underway for sporadic ALS, targeting TDP-43 pathology, STMN2 expression, and neuroinflammation.