Alpha Tau Medical Submits FDA Application for Alpha DaRT Therapy
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 06 2026
0mins
Source: NASDAQ.COM
- Regulatory Milestone: Alpha Tau Medical has submitted the first module of its Pre-Market Approval application for Alpha DaRT therapy targeting recurrent cutaneous squamous cell carcinoma, marking a significant step toward potential U.S. market entry and offering new treatment options for patients.
- 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.
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Analyst Views on DRTS
Wall Street analysts forecast DRTS stock price to fall over the next 12 months. According to Wall Street analysts, the average 1-year price target for DRTS is 7.00 USD with a low forecast of 5.00 USD and a high forecast of 9.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
3 Analyst Rating
3 Buy
0 Hold
0 Sell
Strong Buy
Current: 7.600
Low
5.00
Averages
7.00
High
9.00
Current: 7.600
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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