On May 19, 2025, BrainStorm Cell Therapeutics, Inc. (BCLI) announced that the U.S. Food and Drug Administration (FDA) has cleared the company to initiate the Phase 3b clinical trial of NurOwn for the treatment of amyotrophic lateral sclerosis (ALS). This final regulatory clearance comes after the company submitted an amendment to the Investigational New Drug (IND) application regarding certain technical aspects of the Chemistry, Manufacturing, and Controls (CMC). The trial design was previously agreed upon with the FDA under a Special Protocol Assessment (SPA). The Phase 3b trial, known as ENDURANCE, is now listed on clinicaltrials.gov under ID NCT06973629. The company is now focused on securing the financing necessary to conduct the trial.
