BrainStorm Cell Therapeutics Inc. Receives FDA Clearance to Launch Phase 3b Trial of NurOwn® for ALS

Reuters05-19

BrainStorm Cell <a href="https://laohu8.com/S/LENZ">Therapeutics</a> Inc. Receives FDA Clearance to Launch Phase 3b Trial of NurOwn® for ALS

BrainStorm Cell Therapeutics Inc. has announced the U.S. Food and Drug Administration's clearance for the initiation of a Phase 3b clinical trial of NurOwn® for the treatment of amyotrophic lateral sclerosis (ALS). The trial, which was developed in agreement with the FDA's Special Protocol Assessment, is designed to enroll approximately 200 participants at leading academic medical centers. It will comprise a 24-week randomized, double-blind, placebo-controlled phase, followed by a 24-week open-label extension. The primary endpoint of the study is the change in the ALS Functional Rating Scale-Revised from baseline to week 24. The company has scheduled an investor call and webcast to discuss this development further.

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: IO90789) on May 19, 2025, and is solely responsible for the information contained therein.

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Receives FDA Clearance to Launch Phase 3b Trial of NurOwn® for ALS\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        BrainStorm Cell Therapeutics Inc. has announced the U.S. Food and Drug Administration's clearance for the initiation of a Phase 3b clinical trial of NurOwn® for the treatment of amyotrophic lateral sclerosis (ALS). The trial, which was developed in agreement with the FDA's Special Protocol Assessment, is designed to enroll approximately 200 participants at leading academic medical centers. It will comprise a 24-week randomized, double-blind, placebo-controlled phase, followed by a 24-week open-label extension. The primary endpoint of the study is the change in the ALS Functional Rating Scale-Revised from baseline to week 24. 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