We'd like to share the exciting news that the first patient has been dosed in Regimen G of the HEALEY ALS Platform Trial, testing DNL343, an investigational product developed by Denali Therapeutics.
QALSODY is the first approved treatment to target a genetic cause of ALS.
FDA Advisory Committees provide non-binding recommendations for consideration by the FDA. The New Drug Application for tofersen for the treatment of SOD1-ALS was submitted to the FDA for consideration under accelerated approval. The FDA is continuing its review of tofersen with a Prescription Drug User Fee Act action date of April 25, 2023.
Click here to watch a recording of The ALS Association webinar on Tofersen and the FDA Approval Process.
Healey & AMG Center & the Northeast ALS Consortium announce results in platform trial with pridopidine
Amylyx anticipates topline results in 2024. The study enrolled 664 participants living with ALS.
Serum and cerebrospinal fluid samples from the Phase 3 study of NurOwn® in ALS to be donated to the NEALS biorepository for use by the research community
The HEALEY ALS Platform Trial is adding a new investigational drug, DNL343, to continue to research new treatments for ALS (Amyotrophic Lateral Sclerosis or Lou Gehrig’s disease).
The Annual Meeting of the Northeast Amyotrophic Lateral Sclerosis (NEALS) Consortium brings together clinicians, researchers, and members of the NEALS Consortium to share the latest data and findings in the care of ALS and discuss the hottest topics in neuromuscular medicine.
Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the presentation of an interim analysis of the Phase 4 REFINE-ALS study, designed to identify predictive and pharmacodynamic biomarkers to measure the effect of RADICAVA® (edaravone) in people with amyotrophic lateral sclerosis (ALS).
