What Clene Inc.’s FDA feedback reveals about the future of surrogate endpoints in ALS trials
Can biomarker-driven approvals transform ALS drug development? Explore how Clene Inc.’s FDA feedback on CNM-Au8 could accelerate innovation.
Pharma & Biotech
Pharma & Biotech
What Neurizon’s entry into the HEALEY ALS trial means for the future of NUZ-001
Neurizon Therapeutics Limited has received clearance from the United States Food and Drug Administration for its investigational therapy NUZ-001 to be included in the HEALEY ALS Platform Trial, a globally recognized adaptive trial framework for amyotrophic lateral sclerosis. The decision formally designates NUZ-001 as Regimen I in the platform, allowing clinical site activation and study
Pharma & Biotech
What makes Prilenia’s PREVAiLS trial different from past ALS failures
FDA clears Prilenia’s PREVAiLS ALS trial. Can pridopidine validate neuroprotection and shift the treatment paradigm? Read the full analysis here.