WSW, NY, February 25th, 2026, FinanceWire
Alpha Tau Medical (NASDAQ: DRTS) has achieved a pivotal milestone: Japan’s Ministry of Health, Labour and Welfare has granted Shonin marketing approval for Alpha DaRT in the treatment of unresectable (cannot be surgically removed) locally advanced or locally recurrent head and neck cancer. The decision, announced February 24, 2026, marks the first regulatory approval of the Alpha DaRT platform outside Israel and moves the company into an early commercial phase in Japan.
The approval required passage through Japan’s Shonin process, one of the country’s most rigorous pathways for medical devices. Japan’s PMDA is known for demanding standards, and clearance after a seven-year regulatory effort may be an encouraging signal for pending applications elsewhere. While each regulatory body conducts independent evaluation, a successful Shonin approval demonstrates that the clinical and manufacturing data can satisfy one of the world’s most stringent reviewers.
Radiation is a cornerstone of cancer care, but conventional external-beam radiation can affect circulating immune cells. That matters in an era where checkpoint inhibitors – drugs like pembrolizumab, sold by Merck (NYSE: MRK) as Keytruda, which generated roughly $32 billion in revenue in 202 – have become standard of care across numerous tumor types. These therapies release molecular “brakes” on the immune system, and clinicians often combine them with radiation, reasoning that radiation weakens the tumor while the immune system finishes the job. The tension is that standard radiation can reduce the very immune cells checkpoint inhibitors rely on.
Alpha DaRT approaches radiation from the inside out. The therapy places tiny seeds coated with radium-224 directly inside the tumor. As the radium decays, it releases radiation that travels only a short distance, concentrating damage inside the tumor instead of sending a beam through the body. Cancer cells are destroyed while the circulating immune system is left largely untouched.
To understand why the early data matters, start with pancreatic cancer, one of the deadliest cancers with a five-year survival rate of about 13%. The disease has remained largely resistant to the immunotherapy revolution that transformed outcomes elsewhere. Results from Alpha Tau’s first-in-human pancreatic study, presented at the 2026 ASCO GI Symposium, showed that in 23 patients tracked one month after treatment, immune stress markers did not meaningfully worsen, and IL-6, a protein that rises with inflammation, fell sharply (p<0.000001). Conventional radiation typically drives inflammation upward.
The same 32-patient study reported an 81% disease control rate (percentage of patients whose tumors shrank or stopped growing) and 22% objective response rate (percentage of patients whose tumors shrank or disappeared), rising to 23% when excluding two patients who received reduced doses during initial safety testing. In a disease where median survival with standard chemotherapy is measured in months, a signal like this warrants attention.
A second cancer type produced a result harder to dismiss. In an early combination trial pairing Alpha DaRT with pembrolizumab in recurrent or metastatic head and neck squamous cell carcinoma, the first eight patients showed a 75% objective response rate, compared with about 17% for pembrolizumab alone in Merck’s pivotal KEYNOTE-048 trial (with response rates varying by PD-L1 subgroup). Eight patients is a small cohort and the comparison indirect, but these were patients whose cancer had returned or spread, and a gap of that size is scientifically meaningful.
If immune preservation holds up across larger studies, the commercial implications are significant. Checkpoint inhibitors are now standard of care across more than a dozen cancer types including lung, kidney, bladder, and melanoma. A radiation platform that works with them rather than against them would have a natural home in treatment protocols industry-wide. ARK Invest appears to share this view: in January 2026, the firm added Alpha Tau to its ARK Israel Innovative Technology ETF (IZRL), signaling institutional recognition that the technology sits at the intersection of targeted radiation and immunotherapy.
Alpha Tau currently runs five FDA-authorized U.S. trials spanning skin, pancreatic, brain, and prostate cancers. In January 2026, the company submitted the first module of its pre-market approval application to the FDA for recurrent cutaneous squamous cell carcinoma, for which the agency granted Breakthrough Device Designation. Manufacturing is scaling in parallel, with a U.S. facility in Hudson, New Hampshire licensed in October 2025 with capacity for approximately 400,000 sources annually.
The industry has spent years searching for a radiation platform that complements checkpoint inhibitors rather than undermining them. Alpha DaRT is one of very few technologies generating early clinical evidence that it may do exactly that. With Japan’s commercial authorization in hand and multiple U.S. data readouts expected throughout 2026, the path from clinical concept to commercial reality has begun. The data is early and broader approval is not guaranteed, but the unmet need is real, the mechanism is distinctive, and the regulatory validation is underway.
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