BrainStorm To File US Application For NurOwn In Amyotrophic Lateral Sclerosis

  • BrainStorm Cell Therapeutics Inc BCLI announced its decision to submit a marketing application to the FDA seeking approval for NurOwn for amyotrophic lateral sclerosis (ALS).
  • A correction was made to the Muscle and Nerve publication from December 2021 describing the results of NurOwn's Phase 3 trial in ALS following new clinical analyses, which strengthens the company's original conclusions from the trial.  
  • The correction results in a statistically significant treatment difference of more than 2 points for an average change from baseline in ALSFRS-R (ALS functional scale) in the pre-specified efficacy subgroup of participants with a baseline score of at least 35.
  • Related: BrainStorm Cell ALS Candidate Shows Benefit In Patients With Less Severe Disease.
  • Results of the biomarker analyses showed significant changes across multiple cerebrospinal fluid (CSF) biomarkers following NurOwn treatment, with the most potent effects observed on biomarkers related to neuroprotection and neuroinflammation.
  • The company ended Q2 with cash, cash equivalents, and short-term bank deposits of approximately $12.2 million.
  • Price Action: BCLI shares are up 12.95% at $3.95 during the market session on the last check Monday.
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