Benzinga | Feb 22, 2021 09:02AM EST

FDA Concludes BrainStorm's ALS Cell Therapy Lacks Substantial Data For Submission; Shares Drop

* 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.