BrainStorm receives refusal to file letter from FDA regarding BLA for NurOwn

BrainStorm Cell Therapeutics announced that the company has received a refusal to file letter from the U.S. FDA regarding the company’s New Biologics License Application for NurOwn for the treatment of ALS. The FDA has indicated that the company can request a Type A meeting to discuss the content of the refusal to file letter. "While we are disappointed that the FDA has not accepted our BLA for NurOwn in ALS, we remain committed to NurOwn’s advancement as a treatment for this devastating disease. The company intends to request a Type A meeting and looks forward to continued discussions with the FDA," said Chaim Lebovits, CEO of BrainStorm. "We continue to believe that NurOwn’s Phase 3 trial represents a significant contribution to ALS therapy and will continue to work tirelessly to address the needs of people living with ALS by advancing science and partnering with researchers around the world."