Alpha Tau Announces FDA Approval to Expand Alpha DaRT® U.S. Recurrent Glioblastoma REGAIN Trial; New Trial Data to be Presented at SNO 2026 Annual Meeting

Uzi Sofer, CEO of Alpha Tau

“The FDA's approval to expand REGAIN represents an important milestone in our efforts to advance Alpha DaRT as a potential treatment option for patients with recurrent glioblastoma, a devastating disease with extremely limited treatment options. We believe that the expanded clinical program, together with the additional interim analysis included in the approved protocol, may help inform our future regulatory development strategy in this indication. We are particularly pleased that updated clinical data from REGAIN will be presented at SNO, one of the world's leading forums for neuro-oncology research.”

Robert Den, MD, Chief Medical Officer of Alpha Tau

“The expanded REGAIN protocol will allow us to collect a broader and more comprehensive clinical dataset, including measures of progression-free survival, overall survival, and quality of life. These assessments are particularly important in recurrent glioblastoma, where extending survival while preserving neurological function and quality of life remains a major clinical challenge. We look forward to presenting updated clinical findings at SNO and continuing to build the evidence needed to guide the future development of Alpha DaRT in this indication. We are grateful to Dr. Joshua Palmer and his team at The Ohio State University for their leadership and dedication to this important study, and we look forward to sharing its progress with the medical and scientific community.”