BrainStorm Receives FDA Clearance to Initiate Phase 3b Trial of NurOwn for ALS (PRNewswire) - May 19, 2025 - "BrainStorm Cell Therapeutics Inc...today announced that the U.S. Food and Drug Administration (FDA) has cleared the company to initiate its Phase 3b clinical trial of NurOwn (autologous MSC-NTF cells) for the treatment of amyotrophic lateral sclerosis (ALS)....The trial design was previously agreed upon with the FDA under a Special Protocol Assessment (SPA), confirming the study's endpoints and statistical methodology are appropriate to support a future Biologics License Application (BLA) submission. This clearance allows the company to proceed with patient enrollment."
New P3 trial • Amyotrophic Lateral Sclerosis
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