FDA to Hold Advisory Committee Meeting to Discuss Potential Stem Cell Therapy for ALS

BrainStorm Cell Therapeutics Inc (New York, NY) announced that the Food and Drug Administration (FDA) will hold a meeting of the Cellular, Tissue and Gene Therapies Advisory Committee (AdCOM) on September 27, 2023, to consider the Biologics License Application (BLA) for NurOwn. NurOwn is an investigational mesenchymal stem cell therapy developed as a potential treatment for amyotrophic lateral sclerosis (ALS).

Previously, NurOwn did not meet primary or secondary endpoints during the phase 3 clinical trial (NCT03280056), potentially owing to the inclusion of participants with more advanced stages of ALS in the study. Additionally, the FDA issued a Refusal to File letter regarding the BLA, which BrainStorm Cell Therapeutics Inc. responded to through the File Over Protest procedure.

“We are encouraged by the regulatory flexibility that the FDA has shown over the last year in ALS broadly, and with respect to NurOwn in particular, and believe an Advisory Committee meeting is good for patients,” said Chaim Lebovits, BrainStorm Cell Therapeutics Inc. President & CEO. “

A BLA is a request to trade a biologic product in interstate commerce. BrainStorm Cell Therapeutics Inc also noted a Prescription Drug User Fee Act (PDUFA) target action date of December 8, 2023.