: Brainstorm Cell Therapeutics shares fall more than 50% after FDA advisors vote down ALS treatment

BrainStorm Cell Therapeutics Inc. BCLI shares fell 56% premarket on Thursday after advisors to the U.S. Food and Drug Administration on Wednesday gave a thumbs-down to the company’s investigational treatment for amyotrophic lateral sclerosis (ALS). The FDA advisors voted that the treatment, the mesenchymal stem cell therapy NurOwn, did not demonstrate substantial evidence of effectiveness for treatment of mild to moderate ALS. The FDA laid out its objections in a briefing document ahead of the meeting, saying in part that the therapy’s mechanism of action was “unclear and inconsistent” across the application. Stacy Lindborg, co-CEO of BrainStorm, said in a statement that the committee vote was a “sad outcome for the ALS community,” and that the company believes that “the totality of data presented for NurOwn today provide a compelling case for approval.” Brainstorm shares have dropped 76% in the year to date, while the S&P 500 SPX has gained 11.3%.

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