BrainStorm to try again at Phase III with FDA-agreed trial design

The US Food and Drug Administration has given a green light to BrainStorm Cell Therapeutics (Nasdaq: BCLI) for the design of a Phase IIIb trial of NurOwn (MSC-NTF cells).

The outcome suggests a positive way forward for the New York-based firm, which opted to withdraw its regulatory submission for the amyotrophic lateral sclerosis (ALS) therapy late last year, after the FDA’s advisors  recommended against approval.

That outcome was widely anticipated, given that the agency had  advised against a submission in the first place, citing insufficient efficacy data.