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.
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.
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
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3291075 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Aug 31, 2026 4w ago | 6-K | $14.11 $15.19 | ▲ +7.65% | ▲ +7.84% | $14.77 (+4.68%) |
Aug 10, 2026 7w ago | 6-K | $14.27 $14.27 | · 0.00% | ▲ +1.06% | $14.77 (+3.50%) |
Aug 10, 2026 7w ago | Press Release | $14.27 $14.27 | · 0.00% | ▲ +1.06% | $14.77 (+3.50%) |
Aug 10, 2026 7w ago | 6-K | $13.60 $14.84 | ▲ +9.12% | ▲ +10.03% | $14.77 (+8.60%) |
Jul 21, 2026 10w ago | 6-K | $13.32 $14.26 | ▲ +7.06% | ▲ +4.50% | $14.77 (+10.89%) |
Jul 15, 2026 11w ago | 6-K | $12.46 $13.87 | ▲ +11.32% | ▲ +8.97% | $14.77 (+18.54%) |
Jun 23, 2026 14w ago | 6-K | $10.05 $13.01 | ▲ +29.45% | ▲ +27.52% | $14.77 (+46.97%) |
Jun 3, 2026 17w ago | Press Release | $10.58 $13.23 | ▲ +25.05% | ▲ +26.05% | $14.77 (+39.60%) |
May 11, 2026 20w ago | Press Release | $10.34 $9.19 | ▼ −11.12% | ▼ −10.82% | $14.77 (+42.84%) |
May 8, 2026 21w ago | Press Release | $8.51 $9.35 | ▲ +9.87% | ▲ +9.85% | $14.77 (+73.56%) |
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