Back to the drawing board for BrainStorm after FDA panel vote

28 September 2023

Shares in New York-based stem cell specialist BrainStorm Cell Therapeutics (Nasdaq: BCLI) have fallen around half ahead of the opening bell, after the firm provided a negative regulatory update.

BrainStorm is developing the amyotrophic lateral sclerosis (ALS) candidate NurOwn (autologous MSC-NTF cells), and has submitted for approval based on data from a Phase III trial.

While the study did not meet its primary endpoint, the company said this was likely due to a "floor effect," which makes it difficult to measure disease progression in people with more advanced disease.

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