BRAINSTORM CELL THER (BCLI) – FDA Concludes BrainStorm’s ALS Cell Therapy Lacks Substantial Data For Submission; Shares Drop

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  • The FDA’s initial review concluded that current data from BrainStorm Cell Therapeutics Inc’s (NASDAQ: BCLI) NurOwn Phase 3 trial in amyotrophic lateral sclerosis (ALS) does not sufficiently provide the threshold of substantial evidence to support the marketing application.
  • Also, the FDA advised that this recommendation does not preclude Brainstorm from proceeding with a marketing application submission.
  • “Brainstorm will first consult with principal investigators, ALS experts, expert statisticians, regulatory advisors, and ALS advocacy groups to assess the benefit/risk of a BLA submission before making a final decision,” said Chaim Lebovits, CEO.
  • NurOwn, autologous MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells that have been expanded and differentiated ex vivo.
  • The cells can deliver immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.
  • Price Action: BCLI slipped 26.8% at $5.05 in the premarket session on the last check Monday.