Alpha Tau Medical Expands REGAIN Study to 20 Patients for Alpha DaRT Therapy
The FDA has approved Alpha Tau Medical's expansion of the REGAIN trial, allowing enrollment of up to 20 patients with recurrent glioblastoma.
Jerusalem, Oct. 19, 2026 — Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) announced 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 trial can now enroll up to 20 patients, increased from the previously approved 10 patients, at three U.S. academic cancer centers authorized to participate. This expansion aims to generate additional data on the use of Alpha DaRT to treat recurrent glioblastoma, potentially supporting market submission requirements for this therapy in affected patients.alphatau.com
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Expanded Protocol
The updated protocol opens the study to patients with IDH-mutant grade 4 tumors, classified separately from glioblastoma by the World Health Organization since 2021. It adds progression-free survival as a secondary endpoint and introduces regular quality-of-life assessments. An additional interim analysis is scheduled six months after the fifth patient’s treatment, which occurred in July 2026.
Upcoming Presentation
An abstract has been accepted for presentation at the 31st Annual Meeting of the Society for Neuro-Oncology (SNO), taking place November 12-15, 2026, in Philadelphia. The presentation will include new trial data, building on interim results previously announced by Alpha Tau on May 11, 2026, from the first three treated patients. The SNO meeting is recognized as the world’s largest neuro-oncology conference, attracting over 3,000 researchers and clinician-scientists from more than 40 countries.
Alpha Tau Medical focuses on the research and development of Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy), designed for the treatment of solid tumors. This therapy involves the intratumoral delivery of radium-224 sources, aiming to destroy tumors while sparing surrounding healthy tissue. The company was founded in 2016 and is based in Israel.alphatau.com
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