NurOwn includes autologous mesenchymal stem cells that have been induced to secrete neurotrophic factors.
The company is currently, evaluating NurOwn in a randomized, double-blind, placebo-controlled Phase II clinical trial in ALS patients.
BrainStorm chief executive officer Tony Fiorino said the status will allow them greater and more frequent dialogue with the agency as the company continues the development of this cell therapy for the treatment of ALS.
"We expect Fast Track designation, which recognizes the potential of NurOwn as to address an unmet medical need in ALS, to help speed and improve our development program," Fiorino said.
The FDA Fast Track status is designed to facilitate the development and speed up the review of drugs and biologics intended to treat serious conditions and show the potential to address unmet medical needs.