The Jimmy Fund

ALS Community Files Citizens' Petition Seeking FDA Approval for NurOwn Stem Cell Therapy

- A coalition of ALS patients and families has filed a 309-page Citizens' Petition with the FDA requesting approval of NurOwn, a neurotrophically-enhanced stem cell therapy developed by BrainStorm Cell Therapeutics. - The petition presents unprecedented survival data showing 100% five-year survival in NurOwn's Expanded Access Program participants compared to 20% in natural ALS history, with median tracheostomy-free survival of 7 years. - NurOwn demonstrated statistically significant changes in 23 cerebrospinal fluid biomarkers and up to 85% slowing of ALS progression, supported by real-world evidence from clinical trials and expanded access programs. - The petition argues NurOwn meets approval thresholds for traditional, accelerated, or conditional approval pathways based on survival data, respiratory function preservation, and biomarker evidence.