- Approval establishes first clinical authorization outside Israel and initiates post-market surveillance program - - First-in-kind technology delivers intra-tumoral alpha-emitting radiotherapeutics, reflects strength of clinical data and strong collaboration with Japanese regulators and clinical societies - JERUSALEM, Feb. 24, 2026 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) (“Alpha Tau”), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT®, today announced that ...

Core Insights - Alpha Tau Medical Ltd. has submitted the first module of its pre-market approval (PMA) application to the FDA for its Alpha DaRT therapy aimed at treating recurrent cutaneous squamous cell carcinoma (cSCC) [1][2] - The FDA has granted Alpha Tau a flexible modular submission framework, allowing for streamlined review and feedback as each module is submitted [1][2] - The ReSTART pivotal study, which is currently ongoing, is expected to complete patient recruitment by Q1 2026 [1][2] Company Overview - Alpha Tau Medical Ltd. is an Israeli oncology therapeutics company founded in 2016, focusing on the research, development, and potential commercialization of Alpha DaRT for solid tumors [3] - The Alpha DaRT technology was developed by professors from Tel Aviv University and is designed for targeted alpha-irradiation of tumors [4] Technology Details - Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) utilizes radium-224 sources for intratumoral delivery, aiming to destroy tumors while sparing surrounding healthy tissue [4]

Company Overview - Alpha Tau Medical Ltd. is an Israeli oncology therapeutics company founded in 2016, focusing on the research, development, and potential commercialization of the Alpha DaRT for treating solid tumors [3] - The technology behind Alpha DaRT was initially developed by Prof. Itzhak Kelson and Prof. Yona Keisari from Tel Aviv University [3] Product Information - Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed for highly potent and conformal alpha-irradiation of solid tumors through intratumoral delivery of radium-224 impregnated sources [4] - The therapy aims to destroy tumors while sparing surrounding healthy tissue, as the alpha-emitting atoms diffuse only a short distance [4] Upcoming Events - Alpha Tau will present a corporate overview and update at the J.P. Morgan 2026 Healthcare Conference on January 15, 2026, at 11:15 AM PT / 2:15 PM ET in San Francisco, CA [1] - The presentation will include a review of recent achievements and the outlook for upcoming data milestones [1] - Institutional investor meetings will also be hosted at the event, and a webcast link will be available on the company's Investor Relations page [2]

Core Viewpoint - Alpha Tau Medical Ltd. has successfully treated the first patient in the world with its Alpha DaRT technology for recurrent glioblastoma multiforme (GBM), marking a significant milestone in cancer treatment [3][4]. Company Overview - Alpha Tau Medical Ltd. is an Israeli oncology therapeutics company founded in 2016, focusing on the research, development, and potential commercialization of Alpha DaRT for solid tumors [9]. - The Alpha DaRT technology was initially developed by professors from Tel Aviv University [9]. Technology Details - Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) utilizes intratumoral delivery of radium-224 sources to emit high-energy alpha particles, aiming to destroy tumors while sparing surrounding healthy tissue [10]. - The technology is designed to provide highly potent and conformal alpha-irradiation specifically targeting solid tumors [10]. Clinical Study Insights - The pilot study aims to enroll up to ten U.S. patients with recurrent glioblastoma who are not suitable for surgical resection and have previously undergone central nervous system radiation [8]. - The primary objective of the study is to evaluate the feasibility and safety of the Alpha DaRT treatment, following promising preclinical results [8]. Treatment Significance - The treatment of GBM patients with Alpha DaRT addresses a critical need for new local therapies, given the high recurrence rate of GBM, typically within 6-9 months [4][6]. - The procedure demonstrated excellent feasibility, achieving over 95% coverage of the tumor volume with a novel delivery device that integrates seamlessly into standard neurosurgical workflows [7].

Core Insights - Alpha Tau Medical Ltd. is advancing its innovative alpha-radiation cancer therapy, Alpha DaRT, with a multi-center clinical trial for pancreatic cancer in the U.S. expected to complete patient recruitment by the end of Q1 2026 [1][2] - The company will present two abstracts at the 2026 ASCO Gastrointestinal Cancers Symposium, showcasing data from its recently completed pilot trial in Montreal [1][2] Company Overview - Alpha Tau Medical Ltd. was founded in 2016 and focuses on the research, development, and potential commercialization of Alpha DaRT for treating solid tumors [4] - The technology was developed by professors from Tel Aviv University, emphasizing its academic foundation [4] Clinical Trial Details - The U.S. multi-center pancreatic cancer clinical trial began patient treatment in September 2025 and aims to enroll up to 30 patients with newly diagnosed pancreatic cancer [2] - Approximately 87% of newly diagnosed pancreatic cancer patients are deemed inoperable, highlighting the significant unmet medical need [2] Technology Description - Alpha DaRT utilizes radium-224 for intratumoral delivery, allowing for targeted alpha-irradiation of solid tumors while minimizing damage to surrounding healthy tissue [3]

Core Viewpoint - Alpha Tau Medical Ltd. has received FDA approval for a pilot study using its Alpha DaRT technology to treat locally recurrent prostate cancer, marking its fifth active Investigational Device Exemption (IDE) in the U.S. [1][3] Group 1: Company Developments - The FDA's approval allows Alpha Tau to expand its Alpha DaRT technology into the U.S. market for prostate cancer treatment [1] - The clinical trial will enroll up to 12 patients with locally recurrent prostate cancer, focusing on safety and efficacy evaluations [2] - Alpha Tau aims to provide a new local salvage therapy option for patients facing limited alternatives [3] Group 2: Technology Overview - Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) utilizes radium-224 to deliver targeted alpha-radiation to solid tumors, minimizing damage to surrounding healthy tissue [4] - The technology was developed by researchers from Tel Aviv University and is focused on treating solid tumors [5]

Core Insights - Alpha Tau Medical Ltd. is participating in the Jefferies Global Healthcare Conference in London on November 18-19, 2025, where CFO Raphi Levy will hold 1x1 investor meetings [1] Company Overview - Alpha Tau Medical Ltd. was founded in 2016 and is an Israeli oncology therapeutics company focused on the research, development, and potential commercialization of Alpha DaRT for treating solid tumors [2] - The technology behind Alpha DaRT was developed by Prof. Itzhak Kelson and Prof. Yona Keisari from Tel Aviv University [2] Technology Details - Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed for highly potent and conformal alpha-irradiation of solid tumors through intratumoral delivery of radium-224 impregnated sources [3] - The therapy works by releasing short-lived daughter isotopes from radium-224, which emit high-energy alpha particles aimed at destroying tumors while minimizing damage to surrounding healthy tissue [3]

Core Insights - Alpha Tau Medical Ltd. has received a radioactive material license from the State of New Hampshire, marking a significant milestone for the commercial-scale manufacturing of its Alpha DaRT cancer therapy [1][3] - The company aims to initiate Alpha DaRT treatment manufacturing in 2026, following the completion of the first phase of its facility in Hudson, New Hampshire [1][3] Company Developments - In October 2023, Alpha Tau entered a long-term lease for a building over 14,000 rentable square feet in Hudson, New Hampshire, for the Alpha DaRT manufacturing facility, which will be constructed in multiple phases [2] - The expected nameplate capacity from the first phase is approximately 400,000 Alpha DaRT sources for local use, contingent on operational and clinical assumptions [2] Operational Milestones - CEO Uzi Sofer expressed excitement over the operational milestone and acknowledged the efforts of the operations and engineering teams, as well as the support from local authorities [3] - With the radioactive material license secured, the company can proceed with equipping the facility and aims to produce Alpha DaRT treatments during 2026 [3] Product Overview - Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed for highly potent and conformal alpha-irradiation of solid tumors through intratumoral delivery of radium-224 sources [6] - The therapy is currently being evaluated in multiple clinical trials for various cancers, including skin, head & neck, pancreas, lung, prostate, and brain tumors [4] Company Background - Founded in 2016, Alpha Tau Medical Ltd. is an Israeli oncology therapeutics company focused on the research, development, and potential commercialization of Alpha DaRT for solid tumor treatment [5] - The technology was developed by professors from Tel Aviv University [5]

Core Viewpoint - Alpha Tau Medical Ltd. is actively engaging with investors through multiple conferences in September 2025 to discuss its innovative alpha-radiation cancer therapy, Alpha DaRT, which aims to treat solid tumors while minimizing damage to surrounding healthy tissue [1][3]. Company Overview - Alpha Tau Medical Ltd. is an Israeli oncology therapeutics company founded in 2016, focusing on the research, development, and potential commercialization of the Alpha DaRT technology for treating solid tumors [5]. - The Alpha DaRT technology was developed by Professors Itzhak Kelson and Yona Keisari from Tel Aviv University [5]. Technology Insights - Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) utilizes localized alpha particle radiotherapy to destroy solid tumors while sparing healthy tissue, with the potential for broad applicability in local tumor control [2][4]. - The therapy involves intratumoral delivery of radium-224 sources, which emit high-energy alpha particles that primarily affect the tumor due to their short diffusion distance [4]. Upcoming Events - The CFO, Raphi Levy, will present at several investor conferences in September 2025, including: - Citi 2025 Biopharma Back to School Summit on September 2-3, 2025, in Boston, MA [3] - H.C. Wainwright 27th Annual Global Investment Conference on September 9, 2025, in New York, NY [3] - Oppenheimer's Third Annual Targeted Radiopharmaceutical Therapies in Oncology Summit on September 11, 2025, in New York, NY [3] - RTH & Co / Redburn Atlantic - Radiopharma Landscape Conference on September 26, 2025, in New York, NY [3] - Lytham Partners Fall 2025 Investor Conference on September 30, 2025, virtually [3].

Company Overview - Alpha Tau Medical Ltd. is an Israeli oncology therapeutics company founded in 2016, focusing on the research, development, and potential commercialization of the Alpha DaRT for treating solid tumors [3] - The technology behind Alpha DaRT was developed by Prof. Itzhak Kelson and Prof. Yona Keisari from Tel Aviv University [3] Product Information - Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) utilizes intratumoral delivery of radium-224 impregnated sources to provide highly potent and conformal alpha-irradiation of solid tumors [4] - The therapy aims to destroy tumors while sparing surrounding healthy tissue, as the alpha-emitting atoms diffuse only a short distance [4] Upcoming Events - The CFO of Alpha Tau, Raphi Levy, will present at the Jefferies Global Healthcare Conference on June 5, 2025, from 1:25 to 1:55 PM ET in New York, NY [2] - Mr. Levy will also be available for one-on-one investor meetings during the conference [2]