Alpha Tau Medical Ltd. DRTS
Alpha Tau Medical Ltd. (Nasdaq: DRTS) is an oncology medical device company.
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Alpha DaRT - ReSTART pivotal trial | Recurrent cutaneous squamous cell carcinoma (US) | unclear | NA_NON_THERAPEUTIC |
| Alpha DaRT - Japan head and neck | Unresectable locally advanced or locally recurrent head and neck cancer | unclear | NA_NON_THERAPEUTIC |
| Alpha DaRT - Israel SCC | SCC of the skin or oral cavity | unclear | NA_NON_THERAPEUTIC |
| Alpha DaRT - REGAIN trial | Recurrent glioblastoma multiforme (US) | unclear | NA_NON_THERAPEUTIC |
Recent results and decisions
- Oct 22, 2026n/a Alpha Tau signed an MOU with Samsung Medical Center to explore a potential clinical trial of Alpha DaRT for pancreatic cancer patients in South Korea.
Signing this MOU with Samsung Medical Center, one of the world's leading medical centers, is an important step forward in our goal to bring Alpha DaRT to cancer patients wherever they are.
Filing - Oct 19, 2026n/a FDA approved an IDE supplement expanding REGAIN from 10 to 20 patients, adding PFS and quality-of-life endpoints and an additional interim analysis (trial-design change, not a marketing decision).
The U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) supplement expanding its U.S. REGAIN trial.
Filing - Aug 10, 2026positive Final data from Israeli pilot of Alpha DaRT plus pembrolizumab in HNSCC: 100% ORR in 9 evaluable patients (4 CR, 5 PR), median OS 18.2 months, median PFS 5.4 months; study stopped for success under its two-stage design.
Among evaluable patients, treatment with Alpha DaRT plus pembrolizumab produced an objective response rate (i.e., systemic complete response plus partial response) of 100%, including four complete responses and five partial responses, for a complete response rate of 44%.
Filing
5 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
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The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.