BrainStorm to press on with NurOwn BLA

USA and Israel-based-BrainStorm Cell Therapeutics (Nasdaq: BCLI) is to submit a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for NurOwn (autologous MSC-NTF cells) to treat amyotrophic lateral sclerosis (ALS).

This is despite the FDA telling the company in February that its “current level of clinical data does not provide the threshold of substantial evidence” required for a regulatory submission.

"Key insights that furthered our understanding of the product mechanism of action and therapeutic potential"