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FDA declines to review Brainstorm’s ALS therapy

November 11, 2022


The FDA’s choice marks the latest setback for the NurOwn program.

When that key, late-stage clinical trial failed in late 2020, Brainstorm’s CEO Chaim Lebovits said the company was confident there would be a path forward for its medicine. Brainstorm highlighted, for example, how the trial’s placebo group performed better than expected, and how patients with early ALS appeared to have greater responses to NurOwn treatment.

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