On October 19, 2026 Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported that the U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) supplement expanding its U.S. REGAIN (Recurrent Glioblastoma Alpha DaRT Intratumoral Therapy) trial. The Company also announced that an abstract has been accepted for presentation at the 31st Annual Meeting of the Society for Neuro-Oncology (SNO), to be held November 12 – 15, 2026, in Philadelphia.
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Under the approved supplement, REGAIN can now enroll up to 20 patients, up from the previously approved 10 patients, at the three U.S. academic cancer centers authorized to participate. Based on initial discussions, the Company believes that the expanded trial could generate additional data on the use of Alpha DaRT to treat recurrent glioblastoma, which may support market submission requirements for Alpha DaRT in patients with this disease.
The updated protocol also opens the study to patients with IDH-mutant grade 4 tumors, which the World Health Organization has classified separately from glioblastoma since 2021, adds progression-free survival as a secondary endpoint; and introduces regular quality-of-life assessments. The protocol also provides for an additional interim analysis six months after the fifth patient’s treatment, which occurred in July 2026.
The SNO abstract was submitted by REGAIN principal investigator Dr. Joshua Palmer, Radiation Oncologist at the OSUCCC – James. Titled "First-In-Human Study to Assess the Feasibility and Safety of Intratumoral Diffusing Alpha Emitters for the Treatment of Recurrent Glioblastoma: Safety Interim Analysis (REGAIN)," it will be presented on Friday, November 13, from 7:30 to 9:30 p.m. ET, and will include new trial data, building on the interim results which Alpha Tau had previously announced on May 11, 2026 from the first three treated patients. According to SNO, its annual meeting is the world’s largest neuro-oncology conference, regularly attracting more than 3,000 researchers and clinician-scientists from over 40 countries.
Uzi Sofer, CEO of Alpha Tau, stated: "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, commented: "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."
About the REGAIN Study
The REGAIN study is a prospective, interventional, open-label, single-arm, multicenter study designed to evaluate the feasibility and safety of Alpha DaRT for the potential treatment of recurrent glioblastoma. The study is expected to enroll up to 20 U.S. patients whose recurrent glioblastoma or IDH-mutant grade 4 tumor is not amenable to surgical resection and who have undergone a prior course of central nervous system radiation. Secondary objectives include radiographic local tumor control, the rate of pseudo-progression, overall survival and progression-free survival, and patients’ quality of life. Additional information about the trial can be found at View Source
(Press release, Alpha Tau Medical, OCT 19, 2026, View Source [SID1234673552])