BrainStorm Cell Therapeutics has reached alignment with the FDA on chemistry, manufacturing, and control aspects of a phase 3b clinical trial evaluating debemestrocel (Nurown) cell therapy for the potential treatment of amyotrophic lateral sclerosis (ALS). The news comes a couple of months after the company announced that it had reached an accord with the FDA on a phase 3b trial design for debemestrocel, the endpoints of which would support a biologics license application (BLA) approval for the therapy.