FDA Advisory Panels Gives Thumbs Down To BrainStorm's Lead Therapy

The FDA's Cellular, Tissue and Gene Therapies Advisory Committee meeting reviewing BrainStorm Cell Therapeutics Inc's BCLI NurOwn application voted that NurOwn did not demonstrate substantial evidence of effectiveness for treatment of mild to moderate ALS.

NurOwn is an investigational mesenchymal stem cell therapy for amyotrophic lateral sclerosis (ALS), a motor neuron disease characterized by progressive degeneration of nerve cells in the spinal cord and brain

Members of the Cellular, Tissue, and Gene Therapies Advisory Committee voted 17 to 1, with one abstention, that there was not substantial evidence to show that the company's cell therapy, NurOwn, is effective. 

Before the meeting, the FDA staff reviewers raised concerns over the safety and efficacy of BrainStorm Cell Therapeutics' amyotrophic lateral sclerosis (ALS) therapy.

In its briefing documents, the FDA said it does not believe there is sufficient evidence to support NurOwn's clinical benefit, adding there were several missing data.

The FDA does not believe sufficient evidence supports that any of the assessed biomarkers is reasonably likely to predict clinical benefit.

Last year, BrainStorm Cell received a refusal to file a letter from the FDA regarding its marketing application seeking approval for NurOwn.

Price Action: BCLI shares are down 54.30% at $0.19 during the premarket session on the last check Thursday.