ALPHA TAU MEDICAL LTD · Data as of 2026-09-08
Late 2026
● Completion of patient recruitment in REGAIN recurrent GBM trial in the U.S. in the second half of 2026, with additional data expected to be released by around the end of 2026. For more information, please see here: https://clinicaltrials.gov/study/NCT06910306Source filing
Late 2026
Recently we reported the treatment of our first patient in GBM at Ohio State University (https://www.alphatau.com/single-post/alpha-tau-successfully-treats-first-patient-in-its-u-s-trial-for-patients-with-recurrent-glioblasto). Per the protocol and in line with our conservative approach to carefully watching for any safety signals, we will limit our treatments to one patient per month for the first three patients, all at Ohio State University. To the extent that no safety concerns arise, we would anticipate the removal of enrollment restrictions as well as expansion to New York University as a second site in the trial, in which case we would target the completion of patient accrual for ten patients later in the year, with initial results targeted around year end 2026.Source filing
Sep 2026–Apr 2027
● Top-line data in the ReSTART pivotal U.S. multi-center trial in recurrent cutaneous squamous cell carcinoma in late 2026 or early 2027. For more information, please see here: https://www.clinicaltrials.gov/study/NCT05323253Source filing
Late 2026
We see tremendous importance to generating additional data on the use of Alpha DaRT in tumors of internal organs such as the pancreas and the brain, in order to support future decisions on launch sequencing in different indications. As we have reported in the past, we expect to complete recruitment of the ReSTART study in this quarter, and have started to submit modules of our Modular PMA to the FDA (https://www.alphatau.com/single-post/alpha-tau-submits-first-pre-market-approval-module-to-the-fda-for-alpha-dart-for-the-treatment-of-r), and expect to complete the submission toward year end. Therefore, launch sequencing continues to present interesting strategic questions in light of the broad applicability of Alpha DaRT.Source filing
early 2027
IMPACT was originally approved to enroll 12 patients, and was subsequently expanded three times, the third time at the request of participating clinical sites, to include patients across multiple disease stages and patients receiving either of the two leading first-line chemotherapy regimens. The study now moves from recruitment into follow-up and data maturation, with initial data targeted for early 2027, intended to inform the design of a planned pivotal study.Source filing