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Equity Bottom-Up

BrainStorm Cell Therapeutics I / Equity Bottom-Up

<ul><li>On May 19, 2025, BrainStorm Cell Therapeutics, Inc. (BCLI) announced that the U.S. Food and Drug Administration (FDA) has cleared the company to initiate the Phase 3b clinical trial of NurOwn for the treatment of amyotrophic lateral sclerosis (ALS).</li><li>This final regulatory clearance comes after the company submitted an amendment to the Investigational New Drug (IND) application regarding certain technical aspects of the Chemistry, Manufacturing, and Controls (CMC).</li><li>The trial design was previously agreed upon with the FDA under a Special Protocol Assessment (SPA).</li></ul>

On May 19, 2025, BrainStorm Cell Therapeutics, Inc. (BCLI) announced that the U.S. Food and Drug Administration (FDA) has cleared the company to initiate the Phase 3b clinical trial of NurOwn for the treatment of amyotrophic lateral sclerosis (ALS).This final regulatory clearance comes after the company submitted an amendment to the Investigational New Drug (IND) application regarding certain technical aspects of the Chemistry, Manufacturing, and Controls (CMC).The trial design was previously agreed upon with the FDA under a Special Protocol Assessment (SPA).

BCLI：ALSの第3b相試験開始の規制当局承認を取得 