Alpha Tau Medical Ltd. has submitted the first module of its pre-market approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its Alpha DaRT® therapy, targeting the treatment of recurrent cutaneous squamous cell carcinoma (cSCC). The FDA previously granted Alpha Tau a flexible modular submission framework, allowing for ongoing review and feedback as each module is submitted. This submission focuses on non-clinical study documentation and marks an important milestone in the regulatory review process. Alpha Tau is also conducting the pivotal ReSTART clinical study for Alpha DaRT in cSCC, with patient recruitment expected to complete in the first quarter of 2026. The company has received Breakthrough Device Designation from the FDA for this and other cancer indications.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Alpha Tau Medical Ltd. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9619402-en) on January 05, 2026, and is solely responsible for the information contained therein.