Alpha Tau Medical Receives FDA Approval for Prostate Cancer Clinical Trial
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 02 2025
0mins
Should l Buy DRTS?
Source: Newsfilter
- Clinical Trial Launch: Alpha Tau Medical has received FDA approval to initiate a clinical trial for its Alpha DaRT® technology targeting locally recurrent prostate cancer, with plans to enroll up to 12 patients to evaluate the safety and efficacy of the treatment, thereby providing new options for patients.
- Market Demand Response: With over 300,000 new prostate cancer cases expected in the U.S. in 2025, according to the National Cancer Institute, Alpha Tau's new therapy aims to offer alternatives for patients facing recurrence, addressing clinical needs and enhancing market competitiveness.
- Technological Innovation: Alpha DaRT® utilizes intratumoral delivery of radium-224 to precisely destroy tumors while sparing surrounding healthy tissue, showcasing its potential to transform existing treatment paradigms in oncology.
- Company Growth Prospects: This approval marks Alpha Tau's fifth IDE in the U.S., indicating the company's expansion across various tumor types and further solidifying its market position in cancer treatment, which is expected to drive future business growth.
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Analyst Views on DRTS
Wall Street analysts forecast DRTS stock price to fall
3 Analyst Rating
3 Buy
0 Hold
0 Sell
Strong Buy
Current: 7.230
Low
5.00
Averages
7.00
High
9.00
Current: 7.230
Low
5.00
Averages
7.00
High
9.00
About DRTS
Alpha Tau Medical Ltd is an Israel-based medical technology company that focuses on research, development and commercialization of Alpha DaRT Diffusing Alpha-emitters Radiation Therapy (Alpha DaRT) for the treatment of solid cancer. Company's technology relies on the diffusion of atoms that emit alpha particles within the tumor tissue, and enables alpha radiation to reach the the entire tumor. Precise amounts of radioactive radium-224 affixed that emit short-range alpha radiation enables to damages and kills cancer cells within a short period of time. The Company has one subsidiary Healthcare Capital Corp.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Innovative Treatment Approach: Alpha DaRT utilizes Diffusing Alpha-emitters Radiation Therapy to precisely destroy tumors while sparing surrounding healthy tissue, which could significantly enhance treatment outcomes for patients with difficult-to-treat skin cancers.
- Clinical Trial Progress: This submission coincides with Alpha Tau's ongoing ReSTART pivotal trial, with recruitment expected to complete by Q1 2026, and successful trial results will pave the way for commercialization.
- Accelerated Review Mechanism: The FDA's modular PMA pathway allows for staggered submission and feedback on each module, potentially expediting the overall review process and enhancing Alpha Tau's competitiveness in the complex medical technology landscape.
See More
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See More
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- Investor Engagement: The event will include one-on-one meetings with institutional investors, aimed at strengthening relationships with potential investors and enhancing the company's visibility in the capital markets, thereby laying the groundwork for future financing.
- Technology Background: Alpha DaRT® is an innovative alpha-radiation cancer therapy focused on treating solid tumors through the intratumoral delivery of radium-224 sources, designed to improve treatment precision and efficacy while minimizing damage to surrounding healthy tissue.
- Company Vision: Founded in 2016, Alpha Tau Medical is dedicated to the research, development, and commercialization of Alpha DaRT®, aiming to carve out a niche in the oncology treatment landscape with its unique therapeutic approach to drive long-term growth.
See More
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Innovative Treatment Approach: Alpha DaRT delivers high-energy alpha particles directly into tumors, aiming to destroy cancer cells while minimizing damage to surrounding healthy tissue, and is supported by the FDA's Breakthrough Device Designation.
Pilot Study Details: The trial will enroll up to ten patients with recurrent glioblastoma who are not candidates for surgery, focusing on evaluating the feasibility and safety of the treatment based on promising preclinical results.
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See More
