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.
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 […]
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.