Watch for the SNO presentation on November 13, 2026, which will include updated clinical data from the first three treated patients. The expanded trial could support future market submission requirements for Alpha DaRT in recurrent glioblastoma.
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Executive Summary
Alpha Tau announced FDA approval to expand its U.S. REGAIN trial for recurrent glioblastoma from 10 to 20 patients, with added endpoints and an interim analysis. An abstract with new data has been accepted for presentation at the SNO 2026 Annual Meeting in November. This is a positive regulatory and clinical milestone for a pre-revenue biotech, but no financial figures or efficacy data are disclosed.
Key Facts
- FDA approved IDE supplement expanding REGAIN from 10 to 20 patients at three U.S. academic centers.
- Updated protocol adds IDH-mutant grade 4 tumors, progression-free survival as secondary endpoint, and quality-of-life assessments.
- Additional interim analysis planned six months after fifth patient's treatment (July 2026).
- Abstract accepted for presentation at SNO 2026 Annual Meeting (Nov 12-15, Philadelphia), including new trial data.
- Glioblastoma is the most common malignant primary brain tumor in the U.S., with limited treatment options.
Financial Impact
No financial figures disclosed; pre-revenue clinical-stage company.
Risk Factors
- Alpha DaRT not yet approved for commercialization in glioblastoma; remains investigational.
- Early clinical data may not predict final study results; small sample size (up to 20 patients).
- Company has limited operating history and significant losses; may need additional funding.
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 6-K Filing (Primary) | 0001213900-26-110531 |
| Document: ea0309003-6k_alpha.htm | 0001213900-26-110531 |
| Document: 0001213900-26-110531-index-headers.html | 0001213900-26-110531 |
| Document: 0001213900-26-110531-index.html | 0001213900-26-110531 |
| Document: 0001213900-26-110531.txt | 0001213900-26-110531 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 22, 2026 5d ago | 6-K | $12.90 | awaiting T+60 | — | $13.51 (+4.73%) |
Oct 22, 2026 5d ago | Press Release | $12.90 | awaiting T+60 | — | $13.51 (+4.73%) |
Oct 19, 2026 8d ago | 6-K | $12.62 | awaiting T+60 | — | $13.51 (+7.05%) |
Oct 19, 2026 8d ago | Press Release | $12.62 | awaiting T+60 | — | $13.51 (+7.05%) |
Aug 31, 2026 8w ago | 6-K | $14.11 | awaiting T+60 | — | $13.51 (−4.25%) |
Aug 10, 2026 11w ago | 6-K | $14.27 | awaiting T+60 | — | $13.51 (−5.33%) |
Aug 10, 2026 11w ago | Press Release | $14.27 | awaiting T+60 | — | $13.51 (−5.33%) |
Aug 10, 2026 11w ago | 6-K | $13.60 | awaiting T+60 | — | $13.51 (−0.66%) |
Jul 21, 2026 14w ago | 6-K | $13.32 $13.74 | ▲ +3.15% | ▼ −0.82% | $13.51 (+1.43%) |
Jul 15, 2026 14w ago | 6-K | $12.46 $14.00 | ▲ +12.36% | ▲ +9.83% | $13.51 (+8.43%) |
US Market Status
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