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FDA approves IDE supplement expanding Alpha DaRT REGAIN glioblastoma trial from 10 to 20 patients
DRTSAlpha Tau Medical Ltd.
The U.S. Food and Drug Administration has approved an Investigational Device Exemption (IDE) supplement for Alpha Tau Medical Ltd.'s REGAIN clinical trial, increasing the maximum enrollment from 10 to 20 patients at three authorized U.S. academic centers. The updated protocol expands eligibility to include patients with IDH-mutant grade 4 tumors and adds progression-free survival as a secondary endpoint alongside regular quality-of-life assessments. An interim analysis is scheduled six months after the fifth patient's treatment, which occurred in July 2026. Additionally, an abstract authored by principal investigator Dr. Joshua Palmer has been accepted for presentation at the Society for Neuro-Oncology (SNO) 2026 Annual Meeting in November. Alpha Tau Medical Ltd. is an Israeli oncology therapeutics company focused on developing and commercializing the Alpha DaRT alpha-radiation therapy for solid tumors.