FDA Advisory Panels Gives Thumbs Down To BrainStorm's Lead Therapy
Portfolio Pulse from Vandana Singh
The FDA's Cellular, Tissue and Gene Therapies Advisory Committee has voted against the effectiveness of BrainStorm Cell Therapeutics Inc's (NASDAQ:BCLI) NurOwn application for the treatment of mild to moderate ALS. The FDA staff reviewers had previously raised concerns over the safety and efficacy of the therapy. Last year, BrainStorm Cell received a refusal to file a letter from the FDA regarding its marketing application seeking approval for NurOwn. BCLI shares are down 54.30% at $0.19 during the premarket session on the last check Thursday.
September 28, 2023 | 12:20 pm
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BrainStorm Cell Therapeutics' stock price is likely to be negatively impacted due to the FDA committee's vote against the effectiveness of its NurOwn application for ALS treatment.
The FDA's vote against the effectiveness of BrainStorm Cell Therapeutics' NurOwn application is a significant setback for the company. This negative news is likely to shake investor confidence, leading to a drop in the company's stock price.
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