Shares of BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI) plummeted by 56% in early trading after the company's treatment for amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, received the red light from advisors to the US Food and Drug Administration (FDA).
The Cellular, Tissue, and Gene Therapies Advisory Committee voted 17 to 1, with one abstention, against the efficacy of BrainStorm's cell therapy, NurOwn.
The committee's decision aligns with the FDA's stance over the past two years, asserting that NurOwn has failed to demonstrate any evidence of efficacy.
The FDA had also raised concerns about "a modest excess in deaths" among those treated with NurOwn, although the significance of this was unclear.
BrainStorm submitted an approval application in 2022 based on an exploratory analysis of the same phase 3 trial, which the FDA refused to accept due to insufficient data and unclear manufacturing processes.
At 9.39 am, the stock was changing hands for 17 cents, down 22 cents.