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Alpha Tau Medical Ltd. reported that Japan’s Ministry of Health, Labour and Welfare has granted Shonin marketing approval for its Alpha DaRT® therapy to treat unresectable locally advanced or locally recurrent head and neck cancer. This is the first regulatory approval for the Alpha DaRT platform outside Israel.
As a condition of approval, the company will run a post-market surveillance study in Japan, enrolling 66 patients across five leading clinical centers to further evaluate safety and clinical performance. Alpha Tau and its partner HekaBio are preparing for launch and plan discussions with Japanese authorities about potential reimbursement and additional clinical studies in other tumor types.
An insider has filed a notice of proposed sale under Rule 144 to sell 87,010 ordinary shares through Oppenheimer & Co. Inc. on or about 02/02/2026, with the shares listed on Nasdaq. The aggregate market value of this planned sale is stated as 603,849.40, based on the figures in the notice.
The insider, identified as Gat Amnon, previously sold ordinary shares of the same issuer during the past three months. These earlier sales were 16,000 shares on 11/03/2025 for 62,404.91, 33,351 shares on 12/01/2025 for 148,918.59, and 90,559 shares on 01/02/2026 for 549,741.24. The shares to be sold were originally acquired on 02/21/2017 through an employee stock option plan, with cash payment upon exercise.
Alpha Tau Medical Ltd. provides a detailed update on its Alpha DaRT cancer therapy program, highlighting an expectedly active 2026 with multiple clinical and regulatory milestones. The company now has five concurrently approved trials in the U.S., alongside studies in Europe, Japan and Israel.
Management targets completion of patient recruitment in the IMPACT pancreatic cancer study by the end of Q1 2026, with initial results around year end. A U.S. glioblastoma trial has begun dosing, with plans to enroll ten patients and aim for initial data around the end of 2026, subject to safety review and site expansion.
The company anticipates a regulatory decision in Japan for recurrent head and neck cancer and is progressing its ReSTART pivotal skin cancer trial, expecting to complete enrollment this quarter and finish Modular PMA submission to the FDA toward year end. Alpha Tau continues to ramp manufacturing in Israel and the U.S., build out its New Hampshire facility, invest in automation, and expand intellectual property with dozens of new patent applications and grants while describing its cash burn as stable.
Alpha Tau Medical Ltd. furnished a Form 6-K to provide investors with a press release dated September 2, 2025. The release, attached as Exhibit 99.1, announces that Alpha Tau successfully treated the first patient in its U.S. multi-center pancreatic cancer clinical trial.
The Form 6-K specifies that the information, including the exhibit, is furnished rather than filed under U.S. securities laws, which affects how it is incorporated into other regulatory documents.
Alpha Tau Medical Ltd. furnished a Form 6-K to provide investors with a press release dated August 27, 2025. The release, attached as Exhibit 99.1, announces that the company will participate in five investor conferences scheduled for September.
The furnished information, including the press release, is not deemed filed for liability purposes under the U.S. Exchange Act and is not automatically incorporated by reference into other U.S. securities filings unless specifically referenced there.
Alpha Tau Medical Ltd. filed a Form 6-K furnishing its interim consolidated financial statements as of June 30, 2025 and an operating and financial review for the six months ended June 30, 2025. These documents, plus an August 11, 2025 press release, are incorporated by reference into multiple existing Form F-3 and Form S-8 registration statements.