BrainStorm reaches alignment with FDA on CMC for NurOwn Phase 3b ALS trial

BRAINSTORM CELL THERAPEUTICS INC.

FDA alignment on Chemistry, Manufacturing, and Controls (CMC) for Phase 3b trial of NurOwn for ALS.
Follows April 2024 Special Protocol Assessment (SPA) agreement de-risking trial design and endpoints.
CEO Chaim Lebovits says all previously outstanding CMC questions resolved.
Company moves forward with pivotal Phase 3b trial aiming for NurOwn approval.

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