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BrainStorm Cell Therapeutics Inc. (BCLI) Plunges 10.28% Amid FDA Trial Milestone
Generated by AI AgentAinvest Movers Radar
Friday, Apr 11, 2025 5:37 am ET1min read
On April 11, 2025, BrainStorm Cell Therapeutics Inc. (BCLI) experienced a significant drop of 10.28% in pre-market trading, reflecting investor sentiment amidst broader market movements.
BrainStorm Cell Therapeutics Inc. (BCLI) recently submitted an Investigational New Drug (IND) amendment to the FDA, marking a crucial step toward a pivotal Phase 3b clinical trial for its ALS therapy, NurOwn. This submission, under a Special Protocol Assessment (SPA), confirms that the trial design meets FDA expectations and could support a future Biologics License Application (BLA). The upcoming study will involve 200 patients, featuring a 24-week double-blind period followed by an open-label extension, with the primary endpoint being the change in ALSFRS-R scores, a standard measure of disease progression. CEO Chaim Lebovits described the submission as a major milestone in delivering NurOwn to ALS patients.
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