BrainStorm backers lose nerve ahead of crucial FDA meeting

Ahead of an advisory panel meeting of the US Food and Drug Administration’s scientists, the agency’s  briefing notes paint a pessimistic picture for the amyotrophic lateral sclerosis (ALS) candidate NurOwn (autologous MSC-NTF cells).

Despite receiving  a rebuff from the FDA in 2021, developer BrainStorm Cell Therapeutics (Nasdaq: BCLI) decided to go ahead with a submission, with the firm  putting together a case based on a Phase III trial which met its primary endpoint.

The agency's scientists will meet on Wednesday to discuss the data, with the notes indicating skepticism on what it called “exploratory analyses,” which “provide little confidence on which to base regulatory decisions.”