Alpha Tau Submits PMA Module for Alpha DaRT® to FDA
On January 5, 2026, Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) announced a pivotal step in its journey towards gaining U.S. regulatory approval. The company has submitted the first module of its pre-market approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its innovative alpha-radiation cancer therapy, Alpha DaRT®. This submission is specifically aimed at treating recurrent cutaneous squamous cell carcinoma (cSCC), which represents the second most common form of skin cancer.
Key Milestones in Regulatory Submission
This submission is an important milestone in Alpha Tau's regulatory progression. It follows the FDA's decision to allow the company to utilize a modular framework, which permits a more streamlined review process with ongoing feedback as each module is submitted. The module focuses primarily on comprehensive documentation related to non-clinical studies, which is a requirement under the PMA application.
ReSTART Study in Parallel
Alpha Tau is simultaneously advancing its ReSTART pivotal study, which investigates the efficacy of Alpha DaRT in treating recurrent cSCC. This multi-center trial is currently ongoing and is expected to complete patient recruitment by the first quarter of 2026. The company has received Breakthrough Device Designation from the FDA for this indication, highlighting the potential significance of this treatment.
Leadership Insights
Uzi Sofer, CEO of Alpha Tau, remarked on the importance of this submission, stating, “Alpha Tau continues its fast pace of activity, charging forward in our pursuit of potential marketing authorizations across a wide range of tumors, with an eye toward future commercialization.” He expressed optimism about the dynamic nature of the modular submission process and its potential benefits for accelerating FDA review.
Yaniv Sagie, VP of Quality and Regulatory Affairs, added, “Thank you to our outstanding team for this great accomplishment, our first PMA module submission, and for all of the other achievements working with regulators around the world.”
About Alpha DaRT® Technology
Alpha DaRT, or Diffusing Alpha-emitters Radiation Therapy, utilizes an innovative approach to deliver radium-224 directly into solid tumors. The technology is designed to emit high-energy alpha particles that effectively target and destroy tumor cells while minimizing damage to surrounding healthy tissue. This method offers a promising new treatment option for patients whose conditions do not respond to conventional therapies.
Company Background
Founded in 2016, Alpha Tau Medical Ltd. is an Israeli oncology therapeutics company committed to the research, development, and potential commercialization of its alpha-radiation technology for solid tumors. The foundation of Alpha DaRT technology was laid by esteemed professors from Tel Aviv University, which underscores its innovative medical approach.
Forward-Looking Statements
This press release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. Key aspects including market authorization, patient recruitment in clinical trials, and the FDA review process involve inherent uncertainties. Actual outcomes may differ significantly from those expressed in these forward-looking statements due to various risk factors outlined in Alpha Tau's annual report filed with the SEC.
Contact Information
For further inquiries, investors can reach out to Alpha Tau Medical Ltd. at IR@alphatau.com.