BrainStorm Cell Therapeutics Inc. (BCLI), Monday said that the U.S. Food and Drug Administration (FDA) has given clearance to initiate a Phase 3b study of NurOwn for the treatment of amyotrophic lateral sclerosis (ALS). Following the news, the company's shares were more than 40% up in pre-market.
BrainStorm plans to enroll 200 participants in the Phase 3b study. The primary endpoint is the change from baseline to week 24 in the ALS Functional Rating Scale-Revised (ALSFRS-R).
"We are now positioned to swiftly activate clinical sites in a phased manner, diligently preparing to enroll the first patient in the Phase 3b trial. At the same time, we are actively working to secure funding through multiple avenues, including non-dilutive grants, to ensure the timely and successful launch of this critical study," said Chaim Lebovits, President and Chief Executive Officer of BrainStorm.
BCLI stock has closed at $1.32, up 13.79% on Friday. It has traded in the range of $0.72 - 10.05 in the last 1 year.
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