Alpha Tau Medical Stock Price, News & Analysis

Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) is an Israeli oncology therapeutics company focused on the research, development, and potential commercialization of a novel alpha-radiation cancer therapy known as Alpha DaRT® (Diffusing Alpha-emitters Radiation Therapy) for the treatment of solid tumors. Founded in 2016, the company is described in multiple disclosures and press releases as concentrating its efforts on bringing this technology to patients across a range of tumor types.

According to the company’s public communications, Alpha DaRT is designed to enable highly potent and conformal alpha-irradiation of solid tumors through intratumoral delivery of radium-224 impregnated sources. When radium-224 decays, its short-lived daughter atoms are released from the sources and disperse within the tumor, emitting high-energy alpha particles with the goal of destroying malignant tissue. Because these alpha-emitting atoms diffuse only a short distance, Alpha Tau states that Alpha DaRT aims mainly to affect the tumor while sparing surrounding healthy tissue.

The technology was initially developed by Prof. Itzhak Kelson and Prof. Yona Keisari from Tel Aviv University, as noted in repeated “About Alpha Tau Medical Ltd.” sections across the company’s news releases. Alpha Tau characterizes itself as a clinical-stage company, with its Alpha DaRT treatment being evaluated in multiple clinical trials in indications such as skin, head and neck, pancreatic, lung, prostate and brain tumors, including recurrent cutaneous squamous cell carcinoma (cSCC), recurrent glioblastoma multiforme (GBM), pancreatic ductal adenocarcinoma (PDAC), and locally recurrent prostate cancer.

Business focus and development strategy

Alpha Tau’s communications emphasize a focus on solid tumor indications with high unmet medical need. The company highlights recurrent cSCC in patients not indicated for surgery or standard radiation therapy, recurrent GBM, recurrent squamous cell carcinoma of the oral cavity, pancreatic cancer, and locally recurrent prostate cancer as key areas of clinical investigation. In its press releases, Alpha Tau refers to multi-center pilot studies, pivotal trials, and regulatory pathways aimed at potential marketing authorizations in different regions.

In the United States, Alpha Tau reports that it is conducting a pivotal ReSTART study (Recurrent SCC Treatment with Alpha DaRT Radiation Therapy) in recurrent cSCC, and that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in this indication, as well as for recurrent GBM and recurrent squamous cell carcinoma of the oral cavity with similar criteria. The company also notes participation in the FDA’s Total Product Life Cycle Advisory Program (TAP) in connection with recurrent GBM, which it describes as intended to accelerate market access for the potential treatment.

Beyond skin and head and neck cancers, Alpha Tau reports active or planned trials in pancreatic cancer, including a first-in-human pancreatic cancer study in Montreal, Canada, and a U.S. multi-center pilot study known as IMPACT (Intratumoral Pancreatic Alpha Combination Trial). The Montreal study explored the feasibility, safety, and efficacy of endoscopic ultrasound-guided Alpha DaRT for advanced pancreatic cancer, while the IMPACT trial evaluates Alpha DaRT in combination with chemotherapy for newly diagnosed unresectable locally advanced or metastatic pancreatic adenocarcinoma.

The company also discloses FDA approval of an Investigational Device Exemption (IDE) to initiate a pilot study for locally recurrent prostate cancer, and a pilot study for recurrent GBM in the brain, including the first patient treated with Alpha DaRT in this indication at a U.S. academic center. Across these programs, Alpha Tau describes primary objectives focused on feasibility and safety, with secondary objectives such as measures of disease control and clinical outcomes.

Technology characteristics and therapeutic rationale

In repeated descriptions of Alpha DaRT, Alpha Tau explains that the therapy is intended to combine the high linear energy transfer of alpha particles with a short range of action. By embedding radium-224 in sources placed directly into the tumor, and relying on the diffusion of its short-lived decay products, the company states that Alpha DaRT aims to deliver concentrated alpha radiation within the tumor volume. Because the alpha-emitting atoms travel only a limited distance, Alpha Tau indicates that the treatment is designed to minimize exposure of surrounding normal tissue.

In pancreatic cancer studies referenced in the company’s news releases, Alpha Tau highlights data that suggest disease control rates in treated patients and observations related to inflammatory and immune marker dynamics. The company reports that, in a subset of pancreatic cancer patients with complete laboratory data, certain immune and inflammatory indices did not show significant worsening one month after Alpha DaRT treatment, and that low post-treatment levels of some indices were associated with favorable disease control. It further notes a marked decrease in IL-6 cytokine levels in that study, which is described as a key mediator of inflammation.

In the GBM pilot study, Alpha Tau and its clinical collaborators describe a novel delivery approach for intracranial use, with a device designed to place Alpha DaRT sources in a radial configuration to cover the tumor volume. The company and investigators characterize this as a technically feasible procedure that integrates into standard neurosurgical navigation systems, with the overarching goal of providing a local therapy in a highly sensitive area like the brain.

Manufacturing and operational preparation

Alpha Tau’s public updates also address its progress toward potential commercial readiness. The company reports that it has secured a radioactive material license from the State of New Hampshire Bureau of Public Health Protection, Radiological Health Section, for a commercial-scale Alpha DaRT manufacturing facility in Hudson, New Hampshire. This facility is described as a standalone building constructed in multiple phases, with the first phase designed to support large-scale production of Alpha DaRT sources for local use, subject to operational and clinical assumptions.

With the license in place, Alpha Tau states that it can proceed to equipping the facility, performing verification and validation activities, and introducing thorium generators, with an aim to produce Alpha DaRT treatments at the site. The company presents this facility as part of its broader efforts to prepare for possible future commercial operations and to support clinical and potential commercial supply in the U.S., Canada, and other markets.

Regulatory interactions and clinical-stage status

Alpha Tau’s filings and press releases consistently describe it as a clinical-stage oncology therapeutics company. Its regulatory disclosures include multiple Reports on Form 6-K furnished under the Securities Exchange Act of 1934, which attach interim consolidated financial statements, operating and financial reviews, and press releases detailing clinical and corporate milestones. These filings are incorporated by reference into the company’s registration statements on Form F-3 and Form S-8, as specified in the exhibits to the 6-K dated August 11, 2025.

In addition to U.S. regulatory interactions, Alpha Tau notes that it has submitted a pre-market approval application module to the FDA for Alpha DaRT in recurrent cSCC using a modular PMA framework, and that it has sought marketing authorization in Japan for recurrent head and neck cancer through the Pharmaceuticals and Medical Devices Agency (PMDA. The company’s communications emphasize the use of modular submission to enable ongoing review and feedback from the FDA as each module is provided.

Capital markets and listing

Alpha Tau Medical Ltd. is listed on Nasdaq under the symbols DRTS and DRTSW. The company files periodic and current reports with the U.S. Securities and Exchange Commission, including Form 20-F annual reports and Form 6-K reports, as indicated in the provided filings. The 6-K filings reference the company’s status as a foreign private issuer and its use of Form 20-F for annual reporting.

Investor and conference activity

In its news releases, Alpha Tau reports participation in healthcare and investor conferences, including events hosted by J.P. Morgan, Piper Sandler, Sidoti, and Jefferies. These appearances are described as opportunities for presentations, corporate overviews, and one-on-one or small-group investor meetings. Such activities are presented as part of the company’s efforts to communicate its clinical progress, regulatory milestones, and corporate developments to the investment community.

Risk considerations as disclosed by the company

Alpha Tau’s press releases and SEC filings include forward-looking statements sections that outline a range of risks and uncertainties. Among the factors the company identifies are its ability to receive regulatory approval for Alpha DaRT or any future products or product candidates, its limited operating history, historical losses, need for additional funding, limited experience in medical device discovery and development, dependence on the success and commercialization of Alpha DaRT, and uncertainties related to clinical trial enrollment, outcomes, and side effects. The company also cites exposure to patent litigation, compliance with extensive regulations, the ability to meet Nasdaq listing standards, and changes in applicable laws or regulations, referencing more detailed risk factors in its Form 20-F annual report.

Summary

Overall, based on its own disclosures, Alpha Tau Medical Ltd. is a clinical-stage oncology company centered on Alpha DaRT, a radium-224–based intratumoral alpha-radiation technology for solid tumors. The company’s activities span clinical development in multiple cancer indications, regulatory engagement in several jurisdictions, and preparation of manufacturing infrastructure to support potential future treatment supply. Its securities, including warrants under the symbol DRTSW, trade on Nasdaq, and its regulatory and financial information is made available through SEC filings and company press releases.