On January 5, 2026 Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau", or the "Company"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT reported the submission of the first module of its pre-market approval (PMA) application to the U.S. Food and Drug Administration (FDA), following the FDA’s previous decision to allow the Company to use the more flexible modular approach. The Company submitted the module as part of an application for the use of Alpha DaRT in treating recurrent cutaneous squamous cell carcinoma (cSCC), the second most common form of skin cancer, for patients not indicated for surgery or standard radiation therapy, and for whom no curative systemic treatment is available. This module is focused on comprehensive documentation with respect to non-clinical studies as required under the PMA application.
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Uzi Sofer, CEO of Alpha Tau, stated, "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. The decision by the FDA to allow us to submit our PMA in a modular form will hopefully allow for ongoing FDA review and feedback as each module is submitted, and we look forward to this dynamic and efficient authorization review process with the FDA."
Yaniv Sagie, VP 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. I appreciate the support of our advisors who work closely with us and hope to accomplish great things for Alpha Tau together."
Alpha Tau is currently conducting its multi-center pivotal ReSTART study exploring the use of Alpha DaRT in recurrent cSCC, one of five clinical trials currently approved in the U.S., and anticipates completing patient recruitment in Q1 2026. Alpha Tau has received Breakthrough Device Designation from the FDA in this indication as well as for recurrent glioblastoma multiforme (GBM) and recurrent squamous cell carcinoma of the oral cavity with similar criteria, and is also part of the FDA Total Product Life Cycle Advisory Program (TAP) to accelerate market access for the potential treatment of recurrent GBM.
(Press release, Alpha Tau Medical, JAN 5, 2026, View Source [SID1234661707])