On July 3, 2025, a Citizen's Petition was filed with the U.S. Food and Drug Administration that is asking the agency to invite BrainStorm Cell Therapeutics, Inc. (BCLI) to re-file its Biologics License Application (BLA) for debamestrocel (NurOwn ) for the treatment of amyotrophic lateral sclerosis (ALS). In addition, the petition is requesting the FDA use its "regulatory flexibility" to grant Accelerated Approval or a new Conditional Approval for NurOwn with a Phase 4 confirmatory study. The petition includes data and analysis from all of NurOwn's clinical trials along with additional data from the Expanded Access Program (EAP) that shows 10/10 participants lived greater than 5 years, compared to 20% expected five-year survival based on ALS natural history data. Given the recent changes at the FDA and the comprehensive case outlined in the petition that NurOwn is having a positive impact in ALS patient's lives, we view it as very likely that the company will be invited to resubmit its BLA for NurOwn and we are increasing our valuation to $17 per share based on the increased likelihood that NurOwn gets approved.
