Alpha Tau Medical Ltd. (NASDAQ: DRTS) received Shonin marketing approval from Japan’s Ministry of Health, Labour and Welfare for its Alpha DaRT platform to treat unresectable locally advanced or locally recurrent head and neck cancer. The approval, granted on February 24, 2026, marks the company’s first regulatory clearance outside Israel and confirms the safety and efficacy of Alpha DaRT in a highly regulated market.
The approval includes a post‑market surveillance program that will enroll 66 patients across five leading Japanese clinical centers. Alpha Tau will collaborate with local clinicians to complete the study and will begin discussions with the Ministry of Health about reimbursement strategies, positioning the company to launch Alpha DaRT in Japan and to use the data to support future U.S. and European submissions.
Alpha Tau is a clinical‑stage company that has not yet generated revenue from product sales. For the nine months ended September 30, 2025, the company reported a net loss of $30.5 million, or $0.39 per share, and held $75.9 million in cash and cash equivalents, providing a runway for ongoing clinical development and eventual commercialization.
"Receiving Shonin approval in Japan is a significant milestone for Alpha Tau and for the Alpha DaRT platform. Japan has granted our first marketing approval outside of Israel, and is a country with deep clinical expertise in head and neck oncology. We are grateful to HekaBio for their leadership during this process, and to the six medical societies in Japan who have continually provided their support for the approval and future launch of Alpha DaRT in Japan." – Uzi Sofer, Chief Executive Officer of Alpha Tau
"In parallel we anticipate initiating discussions shortly with the MHLW regarding potential reimbursement approaches for Alpha DaRT in Japan. We believe this approval represents an important first step toward broader clinical evaluation of Alpha DaRT, and look forward to discussing with the PMDA further potential clinical studies in Japan evaluating the use of Alpha DaRT in additional tumor types." – Uzi Sofer, Chief Executive Officer of Alpha Tau
"The Alpha DaRT program has been the primary focus of our team for 7 years, and we're delighted to reach this Shonin milestone with Alpha Tau Medical for the benefit of patients in Japan." – Robert E. Claar, CEO of HekaBio K.K.
Alpha Tau also holds FDA Breakthrough Device Designation for certain cancer types, underscoring the platform’s potential to accelerate regulatory pathways in other major markets.
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