Alpha Tau Gets FDA Clearance for REGAIN Trial Completion; 100% Local Disease Control

Alpha Tau Medical Ltd. announced FDA clearance to complete enrollment for the final seven patients in its U.S. REGAIN trial for recurrent glioblastoma and to add two new clinical sites. This follows a review of an interim safety report for the first three patients, which showed 100% local disease control and a 67% complete response rate with only one grade 3 serious adverse event. The company plans to immediately resume patient recruitment, expanding access and clinical expertise for this indication. This marks another regulatory success, building on Alpha DaRT's Breakthrough Device Designation and acceptance into the FDA's TAP Pilot program.