BrainStorm receives FDA clearance to initiate Phase 3b trial of NurOwn for ALS

BRAINSTORM CELL THERAPEUTICS INC.

FDA cleared Phase 3b trial under Special Protocol Assessment (SPA); endpoints agreed for future BLA.
Trial to enroll ~200 participants at academic centers; 24-week double-blind phase plus 24-week open-label extension.
Primary endpoint: change from baseline to week 24 on ALS Functional Rating Scale-Revised (ALSFRS-R).
Company plans to activate sites in phases and secure funding via non-dilutive grants.
Investor call and webcast scheduled for May 19 at 8:30 a.m. ET.

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