Alpha Tau Medical Ltd (DRTS) has submitted the first module of its Pre-Market Approval application to the U.S. FDA for Alpha DaRT, its alpha-radiation therapy designed for patients with recurrent cutaneous squamous cell carcinoma.
The submission marks a key regulatory milestone as the company progresses toward potential U.S. market entry.
Recurrent cutaneous squamous cell carcinoma (cSCC) is a difficult-to-treat skin cancer, particularly in patients who have exhausted surgery or radiation options. Alpha DaRT uses Diffusing Alpha-emitters Radiation Therapy to deliver highly localized alpha radiation intended to destroy solid tumours while sparing surrounding healthy tissue.
The FDA previously granted Alpha Tau access to a modular PMA pathway, allowing the company to submit components of its application in stages and receive iterative feedback- a process designed to streamline review for complex medical technologies.
The first module was submitted in parallel with Alpha Tau's ongoing ReSTART pivotal trial, a study evaluating Alpha DaRT in patients with recurrent cSCC. Recruitment for ReSTART is expected to be completed in Q1 2026, according to the company.
This PMA submission represents a significant step toward potential commercialisation, pending successful completion of the pivotal study and FDA review.
Alpha Tau noted that the modular approach would allow the FDA to review each section as it is submitted, potentially accelerating the overall timeline once the full PMA package is complete.
DRTS has traded between $2.30 and $5.22 over the past year. The stock closed yesterday's trading at $5.22, up 8.07% and rose further in the overnight trading to $5.23, up 0.19%.
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