Business
Alpha Tau Submits First Pre-Market Approval Module to the FDA for Alpha DaRT® for the Treatment of Recurrent Cutaneous Squamous Cell Carcinoma (cSCC)
- Initial module submission marks an important milestone in the pre-market approval process - - Flexible modular submission framework granted to Alpha Tau by the FDA allows for streamlined review and feedback from the FDA as each module is submitted - - Module submitted in parallel to execution of ReSTART pivotal study (Recurrent SCC Treatment with Alpha DaRT Radiation Therapy), which is expected to complete recruiting patients in Q1 2026 - JERUSALEM, Jan. 05, 2026 (GLOBE NEWSWIRE) -- Alpha Tau
About this update from Alpha Tau Medical Ltd.
[{"type":"image","alt":"Alpha Tau Medical Ltd.","displaySize":"","headline":null,"caption":"Alpha Tau Medical Ltd.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":215,"url":"https://media.zenfs.com/en/globenewswire.com/05605e0853ddac4177652b0fbd0afb40"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/U8Q3xNkSuAPosRUnHeWZmg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTMwMTtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/05605e0853ddac4177652b0fbd0afb40","width":300,"height":215}},"lazy":false},{"type":"text","content":"- Initial module submission marks an important milestone in the pre-market approval process - ","length":93,"tagName":"p"},{"type":"text","content":"- Flexible modular submission framework granted to Alpha Tau by the FDA allows for streamlined review and feedback from the FDA as each module is submitted -","length":157,"tagName":"p"},{"type":"text","content":"- Module submitted in parallel to execution of ReSTART pivotal study (Recurrent SCC Treatment with Alpha DaRT Radiation Therapy), which is expected to complete recruiting patients in Q1 2026 -","length":192,"tagName":"p"},{"type":"text","content":"JERUSALEM, Jan. 05, 2026 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau", or the “Company”), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT® today announced 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.","length":904,"tagName":"p"},{"type":"text","content":"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 a...