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# NurOwn ALS Phase 3 Trial Doesn’t Support Benefit: FDA
- URL: https://www.fdaweb.com/nurown-als-phase-3-trial-doesnt-support-benefit-fda/
- Published: 2021-03-03T12:00:00.000Z
- Updated: 2026-09-14T16:49:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148794

FDA says it is aware that many patients, families, and others in the amyotrophic lateral sclerosis (ALS) community have had high hopes for BrainStorm Cell Therapeutics’ NurOwn therapy. An agency online [notice](https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/update-amyotrophic-lateral-sclerosis-als-product-development?ref=fdaweb.com) says that with the recent completion of a Phase 3 trial comparing NurOwn to placebo, “it has become clear that data do not support the proposed clinical benefit of this therapy.”

None of the trial’s primary or secondary endpoints were met, the notice says, with no statistically significant difference between the active and placebo groups. “In addition,” it says, “there was a modest excess in deaths in those treated with NurOwn, the significance of which is unclear at this time.”

The agency says that if BrainStorm plans further NurOwn studies to determine if it can provide clinical benefit to individuals with ALS, FDA will continue to provide advice to the company on its development program.

The notice says FDA generally cannot provide confidential information about unapproved products but thought it was important to provide high-level information about the status of the NurOwn development program given the interest in it.