BrainStorm Cell Therapeutics Inc. has announced its commitment to proceed with a planned Phase 3b clinical trial, named ENDURANCE, for its treatment NurOwn, targeting amyotrophic lateral sclerosis (ALS). The trial will be conducted under an FDA Special Protocol Assessment $(SPA.UK)$ to generate additional robust data and confirm NurOwn's efficacy and safety in early-stage ALS patients. This development comes as the U.S. Food and Drug Administration (FDA) is set to review a Citizen Petition requesting a new evaluation of the data supporting NurOwn. While BrainStorm was not involved in drafting the petition, the company welcomes the FDA's willingness to reassess the existing data. The results of the Phase 3b trial have not yet been presented, as the trial is planned for future implementation.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Brainstorm Cell Therapeutics Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: LN25930) on July 08, 2025, and is solely responsible for the information contained therein.
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