The press release highlighted the company’s commitment to advancing its lead investigational therapy, NurOwn, into a Phase 3b confirmatory study, which received FDA clearance in 2025. This study aims to generate confirmatory data to support a potential Biologics License Application (BLA) submission. The company emphasized its focus on the ALS community, noting that the recent financing has catalyzed a recovery in its stock price and provided the necessary cash runway to execute key operational activities.
In the Expanded Access Program (EAP), 50% of patients (5 out of 10) remain alive, with an estimated mean survival of approximately 84 months. This data reinforces the strategic focus of the Phase 3b trial on earlier-stage populations where treatment effects may be more detectable. The company’s leadership expressed optimism about the future of NurOwn and its potential to address the significant unmet needs in the ALS treatment landscape.