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.
For comments and feedback contact: editorial@rttnews.com
Business News
June 19, 2026 16:46 ET Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.