FDA approves expansion of Alpha Tau’s REGAIN glioblastoma trial to 20 patients
Alpha Tau Medical announced that the U.S. Food and Drug Administration approved an IDE supplement that doubles enrollment in its REGAIN trial for recurrent glioblastoma from 10 to 20 patients. The expanded protocol adds progression‑free survival and quality‑of‑life as secondary endpoints and permits enrollment of patients with IDH‑mutant grade 4 tumors. The company will present updated trial data at the Society for Neuro‑Oncology annual meeting on November 13, 2026 in Philadelphia.
Why it matters
Alpha Tau said the larger trial could generate additional data to support future market‑submission requirements for its Alpha DaRT therapy. The presentation may influence investor sentiment by providing the first public read‑out of the expanded study.
Key facts
- 1The FDA approved an IDE supplement expanding the REGAIN trial from 10 to 20 patients. stocktitan.net
- 2The updated protocol adds progression‑free survival as a secondary endpoint and introduces regular quality‑of‑life assessments. stocktitan.net
- 3Enrollment may now include patients with IDH‑mutant grade 4 tumors. stocktitan.net
- 4An abstract by principal investigator Dr. Joshua Palmer was accepted for presentation at the Society for Neuro‑Oncology 2026 Annual Meeting. stocktitan.net
- 5The presentation is scheduled for Friday, November 13, 2026, from 7:30 to 9:30 p.m. ET. stocktitan.net
- 6The expanded study can enroll up to 20 patients across three U.S. academic cancer centers. investing.com
Summary written by AlphAI AI Desk from 4 of 4 sources. Not investment advice. Figures are as stated by the linked sources.