DRTS Alpha Tau Medical Ltd.
Price Chart
Executive Summary
Alpha Tau completed enrollment in its ReSTART pivotal trial (88 patients) for Alpha DaRT in recurrent cutaneous squamous cell carcinoma, a key step toward FDA PMA approval. The company has Breakthrough Device Designation and submitted the first PMA module in January 2026. This milestone de-risks the regulatory pathway but approval and commercialization remain uncertain.
Actionable Insight
The completion of enrollment is a positive catalyst, but the stock may have already priced in this milestone. Watch for data readouts and PMA submission progress. Approval is not guaranteed; monitor for any delays or negative data.
Key Facts
- Completed enrollment of 88 patients in ReSTART pivotal trial for recurrent cSCC.
- First U.S. pivotal study for Alpha Tau to complete enrollment.
- Alpha DaRT has FDA Breakthrough Device Designation for this indication.
- First module of modular PMA application submitted in January 2026.
- cSCC is the second most common skin cancer with rising incidence and unmet need.
- Trial co-primary endpoints: objective response rate and duration of response at 6 months.
Financial Impact
No financial figures disclosed; potential future revenue from FDA approval in cSCC, but timeline and market size not quantified.
Risk Factors
- FDA may not approve PMA; clinical data may not meet endpoints.
- Competition from existing and emerging therapies for cSCC.
- Company has limited operating history and needs additional funding.
- Stock may have already priced in this milestone; limited upside from here.
Market Snapshot
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3291075 |
Filters
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Jun 3, 2026
6d ago
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Press Release
| $10.58 $10.29 | ▼ −2.74% | ▼ −3.14% | $9.28 (−12.29%) |
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May 11, 2026
29d ago
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Press Release
| $10.34 $9.88 | ▼ −4.45% | ▼ −4.31% | $9.28 (−10.25%) |
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May 8, 2026
4w ago
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Press Release
| $8.51 $10.34 | ▲ +21.50% | ▲ +21.27% | $9.28 (+9.05%) |
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May 5, 2026
5w ago
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Press Release
| $7.39 $7.59 | ▲ +2.71% | ▲ +1.32% | $9.28 (+25.58%) |
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May 4, 2026
5w ago
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Press Release
| $7.53 $7.39 | ▼ −1.86% | ▼ −2.65% | $9.28 (+23.24%) |
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Apr 27, 2026
6w ago
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Press Release
| $7.91 $7.30 | ▼ −7.71% | ▼ −7.23% | $9.28 (+17.32%) |
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Apr 23, 2026
6w ago
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Press Release
| $7.98 $8.09 | ▲ +1.38% | ▲ +0.59% | $9.28 (+16.29%) |
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Mar 9, 2026
13w ago
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Press Release
| $6.84 $7.04 | ▲ +2.92% | ▲ +3.03% | $9.28 (+35.67%) |
US Market Status
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