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Alpha Tau Files First FDA PMA Module for Alpha DaRT Skin Cancer Therapy

Story Highlights
  • Alpha Tau submitted its first FDA pre-market approval module for Alpha DaRT to treat recurrent cutaneous squamous cell carcinoma on January 5, 2026.
  • The FDA-approved modular submission, aligned with the ongoing ReSTART pivotal study, marks a key regulatory step that may streamline Alpha Tau’s U.S. path in skin cancer therapy.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Alpha Tau Files First FDA PMA Module for Alpha DaRT Skin Cancer Therapy

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An update from Alpha Tau Medical Ltd ( (DRTS) ) is now available.

On January 5, 2026, Alpha Tau Medical announced it has submitted the first module of its pre-market approval application to the U.S. Food and Drug Administration for Alpha DaRT in the treatment of recurrent cutaneous squamous cell carcinoma in patients who are not candidates for surgery or standard radiation and lack curative systemic options. The FDA has allowed the company to use a modular PMA approach, enabling staged review of non-clinical and other data, and the initial module focuses on comprehensive non-clinical documentation; this step, taken in parallel with the ongoing multi-center ReSTART pivotal study that is expected to complete patient recruitment in the first quarter of 2026, marks a key regulatory milestone that could help streamline U.S. review and potentially strengthen Alpha Tau’s position in the skin cancer treatment market if future modules and clinical results support approval.

The most recent analyst rating on (DRTS) stock is a Hold with a $5.00 price target. To see the full list of analyst forecasts on Alpha Tau Medical Ltd stock, see the DRTS Stock Forecast page.

Spark’s Take on DRTS Stock

According to Spark, TipRanks’ AI Analyst, DRTS is a Neutral.

The score is held down primarily by weak financial performance (no revenue, ongoing losses, and continued cash burn), which increases reliance on external funding despite improved balance-sheet solvency. Technicals are a meaningful offset with a strong uptrend and positive momentum, while valuation is not supportive given the negative P/E and lack of dividend yield.

To see Spark’s full report on DRTS stock, click here.

More about Alpha Tau Medical Ltd

Founded in 2016 and based in Israel, Alpha Tau Medical Ltd. is an oncology therapeutics company focused on the research, development and potential commercialization of Alpha DaRT, an alpha-radiation-based therapy for solid tumors. The technology, originating from Tel Aviv University, is designed to deliver highly potent, localized alpha irradiation via intratumoral radium-224 sources that aim to destroy tumors while sparing surrounding healthy tissue.

Average Trading Volume: 135,859

Technical Sentiment Signal: Buy

Current Market Cap: $411.8M

Learn more about DRTS stock on TipRanks’ Stock Analysis page.

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