BrainStorm Cell Therapeutics Submits IND Amendment to FDA for Phase 3b Trial of NurOwn in Amyotrophic Lateral Sclerosis

NEW YORK, April 10, 2025 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading biotechnology company developing cutting-edge cell therapies for neurodegenerative diseases, today announced the submission of an Investigational New Drug (IND) amendment to the U.S. Food and Drug Administration (FDA) for NurOwn®, the company's autologous mesenchymal stem cell therapy for amyotrophic lateral sclerosis (ALS). This important milestone sets the stage for the initiation of BrainStorm's highly anticipated Phase 3b clinical trial, which has been designed in collaboration with the FDA under a Special Protocol Assessment (SPA). The SPA agreement confirms that the Phase 3b trial design and statistical analysis plan is in line with the FDA's expectations, validating its potential to support a future Biologics License Application (BLA). The company now anticipates a swift regulatory review of the IND, clearing the way for the trial's launch.