FDA Clearance for Phase IIIb Trial
Brainstorm Cell Therapeutics received FDA clearance to initiate a pivotal Phase IIIb trial, ENDURANCE, for NurOwn in early-stage ALS patients. This provides regulatory clarity and strengthens the trial's foundation.
Manufacturing Partnership with Minaris
Secured a partnership with Minaris Advanced Therapies to enhance U.S.-based manufacturing capabilities for the upcoming clinical trial.
Support from ALS Community
A citizens petition was filed with the FDA by ALS patients and families, requesting a de novo review of NurOwn's data, showcasing strong community support.