Alpha Tau Medical Ltd. (NASDAQ: DRTS) filed the first module of its pre‑market approval (PMA) application with the U.S. Food and Drug Administration on January 5, 2026, targeting its Alpha DaRT platform for the treatment of recurrent cutaneous squamous cell carcinoma (cSCC). The filing follows the company’s receipt of Breakthrough Device Designation for this indication, positioning Alpha Tau to leverage the FDA’s modular review pathway and receive iterative feedback that could shorten the overall approval timeline.
The Alpha DaRT platform delivers radium‑224–impregnated sources directly into tumors, where short‑lived alpha particles disperse within the malignant tissue and deliver a high‑dose, highly localized radiation dose while sparing surrounding healthy cells. The first PMA module focuses on non‑clinical data—including pre‑clinical safety, dosimetry, and pharmacokinetics—required to support the cSCC indication. By submitting this module early, Alpha Tau can begin the FDA review process while its pivotal ReSTART study continues to generate the clinical data needed for subsequent modules.
The ReSTART pivotal study, which is enrolling patients with advanced cSCC, is expected to complete patient recruitment in the first quarter of 2026. Successful completion of this study will provide the clinical evidence necessary for the next PMA modules and will be a key milestone in Alpha Tau’s strategy to bring Alpha DaRT to a broader range of solid tumors. The company’s modular approach allows it to address any regulatory questions on a per‑module basis, potentially accelerating the overall approval process.
Alpha Tau’s regulatory milestone expands its pipeline beyond its pancreatic and glioblastoma programs. The company’s Breakthrough Device Designation also covers recurrent glioblastoma multiforme and recurrent squamous cell carcinoma of the oral cavity, underscoring the FDA’s recognition of Alpha DaRT’s therapeutic potential. The cSCC market represents the second most common form of skin cancer, with an estimated 64,000 advanced cases in the U.S. that are not effectively treated by current options, translating into a potential annual market value of $3.2 billion to $6.4 billion for this subset alone.
The filing signals Alpha Tau’s intent to capture a sizable and underserved market, potentially creating a new revenue stream that could strengthen its commercial prospects as it pursues FDA clearance for additional solid‑tumor indications. By advancing Alpha DaRT into cSCC, the company not only diversifies its product portfolio but also demonstrates the platform’s versatility across multiple tumor types, reinforcing its position as a pioneer in diffusing alpha‑emitter therapy.
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