BrainStorm Cell Therapeutics Aktie

BrainStorm to Continue with Planned Phase 3b Trial and Remains Committed to Advancing Access for People Living with ALS NEW YORK , July 8, 2025 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today acknowledged that the U.S. Food and Drug Administration's (FDA) consideration of a Citizen Petition requesting a new review of the data supporting NurOwn will provide a critical opportunity to reaffirm its potential as therapy for amyotrophic lateral sclerosis (ALS). A Citizen Petition, submitted to the FDA under the Federal Food, Drug, and Cosmetic Act (21 CFR § 10.30), is a regulatory process that allows any interested party to formally request the Agency to take action on specific matters, such as reviewing data, issuing new guidance, or taking enforcement action.» Mehr auf prnewswire.com

NEW YORK , June 16, 2025 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced new survival data from 10 participants in its Expanded Access Program (EAP) for NurOwn® (autologous MSC-NTF cells) in amyotrophic lateral sclerosis (ALS). The EAP enrolled 10 participants who had previously completed the Phase 3 clinical trial.» Mehr auf prnewswire.com

NEW YORK , May 27, 2025 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced that it has signed a Letter of Intent (LOI) with Minaris Advanced Therapies, a global contract development and manufacturing organization (CDMO) specializing in cell and gene therapies, to manufacture NurOwn® for its upcoming clinical trial. The LOI marks the beginning of a strategic collaboration between BrainStorm and Minaris to initiate the technology transfer of NurOwn® in preparation for clinical trial manufacturing at Minaris' state-of-the-art facility in Allendale, New Jersey.» Mehr auf prnewswire.com