BrainStorm reached alignment with FDA on Phase 3b clinical trial for NurOwn

BrainStorm Cell Therapeutics announced it has reached alignment with the FDA on the Chemistry, Manufacturing, and Controls, or CMC, aspects of Brainstorm’s Phase 3b clinical trial for NurOwn, its investigational therapy for amyotrophic lateral sclerosis, or ALS. This Type C meeting builds upon the positive momentum established in April 2024, when the FDA granted BrainStorm a Special Protocol Assessment, or SPA, agreement for its NurOwn Phase 3b trial. The SPA agreement provided clarity on the design and endpoints of the trial, significantly de-risking the regulatory aspects of the program.