Alpha Tau Gets FDA Clearance to Complete REGAIN GBM Trial Enrollment

On June 11, 2026, Alpha Tau Medical announced that the FDA has cleared the company to complete enrollment in its U.S. REGAIN trial for recurrent glioblastoma (GBM). This decision follows the FDA's review of a pre-specified interim safety report from the first three patients treated with Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy). Early interim results from these patients demonstrated 100% local disease control and a 67% complete response rate per RANO criteria, with only one manageable Grade 3 serious adverse event reported. The company is authorized to immediately recruit the remaining seven patients for the ten-patient feasibility and safety study. Additionally, the FDA approved the expansion of the trial to two more leading U.S. academic cancer centers. Alpha DaRT previously received FDA Breakthrough Device Designation for recurrent GBM and was selected for the FDA’s Total Product Life Cycle Advisory Program (TAP). The company aims to provide a transformative treatment option for GBM, an indication with high unmet need and poor survival rates.