Alpha Tau Medical Ltd. (DRTS), a clinical-stage oncology company pioneering Alpha DaRT for solid tumors, has several key milestones approaching in the next few months.
The company's lead therapeutic platform, Alpha DaRT, is being developed for the treatment of solid tumors by delivering localized alpha radiation to destroy cancer cells while sparing surrounding healthy tissue.
Alpha Tau is advancing Alpha DaRT in multiple indications. Its pivotal ReSTART trial is evaluating Alpha DaRT in recurrent cutaneous squamous cell carcinoma (cSCC) and continues to enroll patients in the U.S., with completion of recruitment expected in the first quarter of 2026. The study is intended to serve as the foundation for potential regulatory submissions.
Alpha Tau has built a broad pipeline for Alpha DaRT, spanning multiple solid tumor indications across late- and early-stage studies:
In head and neck cancer, Alpha Tau has requested marketing authorization from Japan's PMDA for recurrent diseases, with a response anticipated around year-end 2025. In Israel, Alpha DaRT is being tested in oral cavity squamous cell carcinoma and, in a separate study, combined with pembrolizumab in locally advanced or metastatic head and neck squamous cell carcinoma.
The company is also pursuing Alpha DaRT in pancreatic cancer, where a U.S. multi-center pilot study is currently underway. Recruitment is expected to be completed by the end of the first quarter of 2026. The trial is particularly significant given the high unmet need in pancreatic cancer, where most patients are inoperable at diagnosis.
In glioblastoma, Alpha Tau expects to treat the first patient in its U.S. pilot study before the end of 2025. Studies in brain metastases are also ongoing in Israel and the U.S.
Additonal programs include feasibility studies in liver metastases in Canada, lung cancer in Israel, Prostate cancer in Israel, and vulvar cancer in the U.K. These early-stage studies are designed to expand Alpha DaRT's reach into difficult-to-treat solid tumors.
Financially, Alpha Tau reported a net loss of $30.5 million for the first nine months of 2025, compared with $23.6 million in the same period of 2024, as losses widened year over year due to increased R&D and clinical trial activity.
The company ended September 30, 2025, with cash and equivalents of $75.9 million, sufficient to fund its current operating plan into 2027.
Alpha Tau emphasized progress towards regulatory readiness, including licensing of its New Hampshire manufacturing facility and ongoing interactions with Japan's PMDA for a potential approval pathway.
DRTS has traded in the range of $2.20 to $4.69 over the past year. The stock closed yesterday's trading at $3.47, down 5.45%.
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