Core Insights - BrainStorm Cell Therapeutics Inc. is participating in the 4th Annual ALS Drug Development Summit, showcasing its expertise in ALS clinical research and the NurOwn® development program [1][5] Company Developments - Netta Blondheim-Shraga, PhD, will present new insights into cerebrospinal fluid biomarker pathways related to Debamestrocel (NurOwn), focusing on their connection to clinical outcomes and disease heterogeneity in ALS [2] - The company is preparing to launch its Phase 3b clinical trial of NurOwn, which has received a Special Protocol Assessment (SPA) from the FDA, indicating that the trial's design is adequate for future marketing application if successful [5] - Dr. Bob Dagher will moderate a workshop on adaptive and decentralized clinical trial models aimed at improving enrollment and reducing the burden on ALS patients [3][4] Research and Development - Biomarker data from a prior Phase 3 study suggests a multimodal mechanism of action for NurOwn, enhancing understanding of its influence on ALS disease pathways [3] - The upcoming Phase 3b trial will refine patient selection criteria and trial design based on learnings from previous studies [4] - The NurOwn clinical program has provided valuable insights into ALS biology, including pharmacogenomic responses and biomarker data collected over time [6] Industry Context - A panel discussion will address the role of patient and caregiver engagement in clinical trials and the impact of the diagnostic journey on trial decision-making [4] - The company is advancing a proprietary exosome-based platform for therapeutic delivery, further strengthening its intellectual property portfolio in regenerative medicine [8]