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Equity Bottom-Up

BrainStorm Cell Therapeutics I / Equity Bottom-Up

<ul><li>On July 3, 2025, a Citizen's Petition was filed with the U.S. Food and Drug Administration that is asking the agency to invite BrainStorm Cell Therapeutics, Inc. (BCLI) to re-file its Biologics License Application (BLA) for debamestrocel (NurOwn ) for the treatment of amyotrophic lateral sclerosis (ALS).</li><li>In addition, the petition is requesting the FDA use its "regulatory flexibility" to grant Accelerated Approval or a new Conditional Approval for NurOwn with a Phase 4 confirmatory study.</li><li>The petition includes data and analysis from all of NurOwn's clinical trials along with additional data from the Expanded Access Program (EAP) that shows 10/10 participants lived greater than 5 years, compared to 20% expected five-year survival based on ALS natural history data.</li></ul>

On July 3, 2025, a Citizen's Petition was filed with the U.S. Food and Drug Administration that is asking the agency to invite BrainStorm Cell Therapeutics, Inc. (BCLI) to re-file its Biologics License Application (BLA) for debamestrocel (NurOwn ) for the treatment of amyotrophic lateral sclerosis (ALS).In addition, the petition is requesting the FDA use its "regulatory flexibility" to grant Accelerated Approval or a new Conditional Approval for NurOwn with a Phase 4 confirmatory study.The petition includes data and analysis from all of NurOwn's clinical trials along with additional data from the Expanded Access Program (EAP) that shows 10/10 participants lived greater than 5 years, compared to 20% expected five-year survival based on ALS natural history data.

BCLI：FDAにNurOwnの承認を求める市民請願書が提出される  