FDA Clears Alpha Tau to Double REGAIN Glioblastoma Trial to 20 Patients
DRTS has more than doubled off its 52-week low of $3.43.
Summary
The FDA let Alpha Tau double its U.S. REGAIN recurrent glioblastoma trial from 10 to 20 patients and broaden its endpoints, with first trial data due at SNO on November 13, 2026.
Key Events · Product Development and Regulatory · DRTS
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REGAIN Trial Expanded to 20 Patients
FDA approved an IDE supplement raising U.S. REGAIN enrollment from 10 to 20 patients across three academic cancer centers.
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Broader Endpoints and Eligibility
Protocol now includes IDH-mutant grade 4 tumors, adds progression-free survival as a secondary endpoint, and introduces regular quality-of-life assessments.
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Interim Analysis Added
An additional interim analysis is scheduled six months after the fifth patient's treatment, which occurred in July 2026.
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First REGAIN Data at SNO
An abstract by principal investigator Dr. Joshua Palmer was accepted for presentation November 13, 2026, at the SNO Annual Meeting, with new data beyond the May 11, 2026 three-patient interim results.
Analysis · DRTS · Industrial Applications And Services
The FDA has approved an IDE supplement allowing Alpha Tau to enroll up to 20 patients in its U.S. REGAIN recurrent glioblastoma trial, up from 10, across three academic cancer centers. Under the revised protocol, eligibility now extends to IDH-mutant grade 4 tumors, progression-free survival and quality-of-life endpoints are added, and an interim analysis is built in six months after the fifth patient's treatment (which occurred in July 2026). Management says the larger dataset could inform the regulatory path in this indication, though no approval timeline is given. Separately, the first REGAIN data will be presented at SNO on November 13, 2026, building on the three-patient interim results disclosed May 11, 2026. Because this is an early-stage, single-arm feasibility study, it moves the brain-cancer program forward without changing the near-term revenue picture.
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At the time of this filing, DRTS was trading at $12.60 on NASDAQ in the Industrial Applications And Services sector, with a market capitalization of approximately $1.2B. The 52-week trading range was $3.43 to $15.79. This filing was assessed with positive market sentiment and an importance score of 7 out of 10.