BrainStorm Cell Therapeutics submitted an SPA request to the FDA for a Phase 3b trial of NurOwn® for ALS treatment.

BrainStorm Cell Therapeutics shares rose 7.2% after the company submitted a Special Protocol Assessment (SPA) request to the FDA for a study on its potential treatment for amyotrophic lateral sclerosis (ALS). If approved, the study would be the company's Phase 3b trial for NurOwn®, its investigational treatment for ALS. The SPA request follows an in-person meeting with the FDA in December 2023, which provided guidance on advancing the planned Phase 3b trial.

February 23, 2024
19 Articles

Further Reading