FDA Extends Tofersen Review Period to April 2023
The U.S. Food and Drug Administration (FDA) is extending by three months its review of tofersen, Biogen’s investigational treatment…
Articles by Lindsey Shapiro, PhD
PrimeC for ALS Shows Safety, Good Profile as Extended-release Tablet
An extended-release formulation of PrimeC, an investigational combination therapy for amyotrophic lateral sclerosis (ALS), demonstrated a favorable pharmacokinetic profile…
Biomarkers Boosted by NurOwn Regardless of Disease Severity: Data
NurOwn, Brainstorm Cell Therapeutics’ investigational cell-based therapy, leads to meaningful disease-related biomarker changes regardless of amyotrophic lateral sclerosis…
COURAGE-ALS Trial of Reldesemtiv to Continue After Interim Analysis
The COURAGE-ALS Phase 3 trial of Cytokinetic’s experimental therapy reldesemtiv in people with amyotrophic lateral sclerosis (ALS) will…
ALS Therapy Verdiperstat Fails to Meet Efficacy Goals in HEALEY Trial
Biohaven‘s therapy candidate verdiperstat did not significantly slow functional decline among people with amyotrophic lateral sclerosis (ALS) in…
CNM-Au8 Shows Survival Benefit in HEALEY Trial: New Top-line Results
Treatment with a 30 mg dose of CNM-Au8 significantly reduced the risk of death, and the risk of death…
Relyvrio (AMX0035) Approved in US for ALS Treatment
Note: This story was updated Sept. 30, 2022, to correct the spelling of Albrioza and clarify the FDA advisory committee…
Early CNM-Au8 Continues to Show Survival Benefits in ALS Patients
Early treatment with CNM-Au8 continues to demonstrate survival benefits in people with amyotrophic lateral sclerosis (ALS) compared with…
ALS Association Funds Study of Foralumab Nasal Spray
Researchers at Brigham and Women’s Hospital (BWH) have received a grant from the ALS Association to study foralumab nasal…
Investigational Fatty Acid RT001 Slows ALS Progression in Pilot Study
RT001, an investigational treatment for amyotrophic lateral sclerosis (ALS), shows promising signs that it can slow disease progression,…