BrainStorm Cell Therapeutics Inc. Receives FDA Clearance to Launch Phase 3b Trial of NurOwn® for ALS

Reuters
2025.05.19 11:01
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BrainStorm Cell Therapeutics Inc. has received FDA clearance to initiate a Phase 3b clinical trial of NurOwn® for ALS treatment. The trial will enroll around 200 participants at top medical centers and includes a 24-week randomized, double-blind, placebo-controlled phase, followed by a 24-week open-label extension. The primary endpoint is the change in the ALS Functional Rating Scale-Revised from baseline to week 24. An investor call and webcast are scheduled to discuss this development further.