With U.S. FDA clearance secured, the Company is advancing key pre-initiation activities for the Phase 3b clinical trial of NurOwn (PRNewswire) - Nov 14, 2025 - "The upcoming Phase 3b ENDURANCE study, is expected to enroll approximately 200 participants at leading ALS centers. The trial will include a 24-week, randomized, double-blind, placebo-controlled period (Part A), followed by a 24-week open-label extension (Part B) to further assess long-term safety and durability of effect. The primary efficacy measure will be change from baseline to Week 24 on the ALSFRS-R. Data from Part A is expected to support a Biologics License Application (BLA)."
Trial status • Amyotrophic Lateral Sclerosis
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