Monitor for subsequent data readouts and PMA submission progress; approval would open a significant market opportunity, but regulatory and funding risks remain high. Historical stock reaction to clinical milestones on this ticker has been muted or negative, suggesting tempered expectations.
Price Chart
Executive Summary
Alpha Tau completed enrollment of 88 patients in its U.S. pivotal ReSTART trial for Alpha DaRT in recurrent cutaneous squamous cell carcinoma, a key milestone toward potential FDA PMA approval. The company has Breakthrough Device Designation and initiated the modular PMA process in January 2026. No financial data was provided; the event is a clinical milestone with no revenue impact yet.
Key Facts
- Enrolled all 88 patients in the ReSTART pivotal trial for recurrent cSCC
- First U.S. pivotal study to complete enrollment for Alpha Tau
- Alpha DaRT received Breakthrough Device Designation from FDA
- First module of modular PMA application submitted in January 2026
- Study co-primary endpoints: objective response rate and duration of response at 6 months
Financial Impact
No financial figures reported; potential future revenue contingent on FDA approval, currently pre-revenue
Risk Factors
- FDA approval not guaranteed; pivotal trial results may not meet endpoints
- Company has significant losses and may need additional capital to fund operations and commercialization
- Competition from other skin cancer treatments
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 6-K Filing (Primary) | 0001213900-26-053589 |
| Document: ea028978301-6k_alphatau.htm | 0001213900-26-053589 |
| Document: 0001213900-26-053589-index-headers.html | 0001213900-26-053589 |
| Document: 0001213900-26-053589-index.html | 0001213900-26-053589 |
| Document: 0001213900-26-053589.txt | 0001213900-26-053589 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Jun 3, 2026 17w ago | 6-K | $1.02 $4.00 | ▲ +292.16% | ▲ +289.66% | — |
Jun 1, 2026 17w ago | 6-K | $1.02 $3.89 | ▲ +281.37% | ▲ +280.14% | — |
May 18, 2026 19w ago | 6-K | $1.02 $3.89 | ▲ +281.37% | ▲ +275.08% | — |
May 11, 2026 20w ago | 6-K | $1.02 $3.37 | ▲ +230.39% | ▲ +226.00% | — |
May 11, 2026 20w ago | 6-K | $1.02 $3.37 | ▲ +230.39% | ▲ +226.00% | — |
May 8, 2026 21w ago | 6-K | $1.02 $3.30 | ▲ +223.53% | ▲ +218.69% | — |
May 8, 2026 21w ago | 6-K | $1.02 $3.30 | ▲ +223.53% | ▲ +218.69% | — |
May 7, 2026 21w ago | 6-K | $1.02 $2.58 | ▲ +152.94% | ▲ +149.11% | — |
May 5, 2026 21w ago | 6-K | $1.02 $2.70 | ▲ +164.71% | ▲ +161.97% | — |
May 4, 2026 21w ago | 6-K | $1.02 $2.29 | ▲ +124.51% | ▲ +122.65% | — |
US Market Status
Subscribe to SecBot
Get Real-Time SEC Filing Intelligence
Comprehensive SEC filing analysis delivered the moment filings hit EDGAR. Sentiment scoring, impact analysis, and actionable insights for every material event.
Try SecBot Free Coming soon: SecBot Pro with alerts, watchlists, and API access