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.