BrainStorm Cell Therapeutics Announces FDA Advisory Committee Meeting to Review Biologics License Application for NurOwn® for the Treatment of ALS

NEW YORK, 27 mars 2023

NEW YORK, March 27, 2023 -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that the U.S. Food and Drug Administration (FDA) will hold an Advisory Committee Meeting ('ADCOM') to discuss the company's Biologics License Application (BLA) for NurOwn^® for the treatment of amyotrophic lateral sclerosis (ALS). Given the goal to proceed to an ADCOM as expeditiously as possible, BrainStorm requested that the Center for Biologics Evaluation and Research (CBER) utilize the FDA's File Over Protest procedure and has filed an amendment to the BLA which responds to most of the outstanding questions the FDA has posed. 

"The FDA provided us with more than one path to an ADCOM for NurOwn. Our goal has always been to make NurOwn available to people living with ALS as quickly as possible, therefore we chose the File Over Protest pathway since this offered the fastest path to an ADCOM and regulatory decision relative to other pathways provided by the FDA," said Chaim Lebovits, President and Chief Executive Officer of BrainStorm. "The ALS community needs additional treatment options now, and we firmly believe our data support regulatory approval of NurOwn. We are grateful to the FDA for the opportunity to have the clinical evidence supporting NurOwn reviewed."

Stacy Lindborg, Ph.D., BrainStorm's Co-Chief Executive Officer commented, "ALS is a horrific, neurodegenerative disease that moves at a terrifying speed, robbing people of their ability to move, speak, eat, and breathe. Securing an ADCOM represents an important step towards our goal of making NurOwn broadly available to individuals living with ALS who are in urgent need of new, effective therapies. The meeting will provide an open forum for BrainStorm and the FDA, together with medical experts, statisticians, and the ALS community, to thoughtfully review all available evidence supporting NurOwn. We remain confident in NurOwn and we are committed to doing everything in our power to make the product available quickly to people living with ALS. We look forward to a robust scientific discussion."

Brian Wallach, patient advocate and founder of the non-profit organization I AM ALS, added, "I want to thank the FDA and BrainStorm for having this important ADCOM. As was said in the petition submitted to the FDA and signed by over 30,000 people living with ALS, caregivers, and advocates, 'an Advisory Committee Meeting will allow for an independent review of NurOwn as well as the data on efficacy and safety. It is critical for all ALS treatments that they be given the chance to proceed to an ADCOM.' The ALS community has waited years for this ADCOM. It is time to let the science have a full, fair, and transparent hearing so that we can get this treatment to people who are living with and dying from ALS as soon as possible."