Research analysts covering Alpha Tau Medical.
Recent press releases and 8-K filings for DRTS.
Alpha Tau Medical's Alpha DaRT receives approval in Japan
DRTS
Product Launch
New Projects/Investments
- Alpha Tau Medical's solid tumor treatment device, Alpha DaRT, has received official approval in Japan.
- This approval marks Japan as the first country outside of Israel to approve Alpha DaRT.
- Alpha DaRT is approved for the treatment of unresectable locally advanced or recurrent head and neck cancer.
- HekaBio K.K., as the Designated Marketing Authorization Holder, will be responsible for launching the product in the Japanese market.
7 days ago
Alpha Tau Medical receives Japanese marketing approval for Alpha DaRT
DRTS
Product Launch
New Projects/Investments
- Alpha Tau Medical Ltd. announced on February 24, 2026, that its Alpha DaRT® therapy received Japanese Marketing Approval (Shonin) for unresectable locally advanced or locally recurrent head and neck cancer.
- This marks the first regulatory approval for the Alpha DaRT platform outside Israel.
- As part of the approval, Alpha Tau is required to conduct a post-market surveillance study involving 66 patients at five clinical centers in Japan.
8 days ago
Alpha Tau Medical Receives Japanese Marketing Approval for Alpha DaRT
DRTS
Product Launch
New Projects/Investments
- Alpha Tau Medical (DRTS) has received Shonin marketing approval in Japan for its Alpha DaRT® cancer therapy for the treatment of unresectable locally advanced or locally recurrent head and neck cancer.
- This approval represents the first clinical authorization for Alpha DaRT outside Israel.
- As a condition of the approval, Alpha Tau will conduct a post-market surveillance study enrolling 66 patients across five clinical centers in Japan.
8 days ago
Alpha Tau Medical Provides Shareholder Update on Clinical Trials and Commercialization Milestones
DRTS
New Projects/Investments
Guidance Update
Product Launch
- Alpha Tau Medical Ltd. is actively conducting five concurrent clinical trials in the U.S. for its Alpha DaRT therapy, targeting various cancers including recurrent cutaneous squamous cell carcinoma, pancreatic cancer, glioblastoma multiforme, and prostate cancer.
- Key upcoming milestones include the completion of patient accrual for the IMPACT pancreatic cancer study by the end of Q1 2026 with initial results by the end of 2026, and initial glioblastoma multiforme (GBM) results around the end of Q4 2026.
- The company is awaiting a regulatory decision from Japan for Alpha DaRT in recurrent head & neck cancer, which could be its first commercial approval outside of Israel, and is progressing towards U.S. commercialization with the completion of ReSTART study recruitment in Q4 2025 and an anticipated full Modular PMA submission to the FDA by year-end 2026.
- Alpha Tau also reported filing over 60 new patent applications and being granted or allowed nearly 50 patents in 2025, strengthening its intellectual property portfolio.
Jan 29, 2026, 2:00 PM
Alpha Tau Discusses 2026 Milestones and Clinical Trial Progress
DRTS
New Projects/Investments
Guidance Update
- Alpha Tau is targeting completion of patient recruitment for its pivotal study in recurrent cutaneous squamous cell carcinoma (SCC) in Q1 2026, with data expected later in 2026 for potential FDA approval submission, following the submission of the preclinical module of its modular PMA application.
- The company presented strong final results from its first pancreatic cancer study, showing 100% feasibility and over 80% disease control, and expects its U.S. pilot study in pancreatic cancer to wrap up in H1 2026.
- Alpha Tau successfully treated its first patient in a Glioblastoma (GBM) study, achieving 95% tumor coverage in the initial treatment, with the study expected to conclude later in 2026.
- Alpha Tau secured a radioactive license for its new commercial-scale manufacturing facility in Hudson, New Hampshire, and plans to bring in equipment and isotopes for validation during 2026 to support future commercialization.
- The company reported $76 million in cash and deposits at Q3 (presumably Q3 2025) and a quarterly operational burn rate of $5 million to $5.5 million, indicating it is well-financed for execution.
Jan 15, 2026, 9:00 PM
Alpha Tau Updates on Clinical Milestones, Regulatory Pathway, and Manufacturing Readiness
DRTS
New Projects/Investments
Guidance Update
Product Launch
- Alpha Tau's pivotal study for recurrent cutaneous SCC is expected to complete patient recruitment in Q1 2026, with data anticipated later in 2026 for potential FDA approval submission.
- The company has initiated a rolling submission for its PMA application for recurrent cutaneous SCC with the FDA, having already submitted the preclinical module.
- Positive final results from the first pancreatic cancer study demonstrated 100% feasibility and over 80% disease control, alongside immune-preserving and anti-inflammatory effects.
- Alpha Tau is advancing its commercial-scale manufacturing facility in Hudson, New Hampshire, having secured the radioactive license and aiming to complete equipment and validation in 2026.
- As of Q3 (period not specified, but context implies Q3 2025), Alpha Tau held $76 million in cash and deposits, with a quarterly operational burn rate of $5 million to $5.5 million.
Jan 15, 2026, 9:00 PM
Alpha Tau Provides Updates on Clinical Trials and Manufacturing Expansion
DRTS
New Projects/Investments
Guidance Update
- Alpha Tau is targeting completion of patient recruitment for its pivotal U.S. study in recurrent cutaneous SCC in Q1 2026, with data expected later in 2026 for FDA approval submission, leveraging a rolling PMA submission process.
- The company is also advancing clinical trials for pancreatic cancer and glioblastoma (GBM), with the U.S. pilot study for pancreatic cancer and the GBM study expected to wrap up later in 2026.
- Alpha Tau has secured a radioactive license for its new commercial-scale manufacturing facility in Hudson, New Hampshire, and plans to complete equipment installation and validation throughout 2026 to support future commercialization.
- As of Q3 2025, Alpha Tau reported $76 million in cash and deposits, with a quarterly operational burn rate of $5 million to $5.5 million, indicating it is well-financed for its current execution plans.
Jan 15, 2026, 9:00 PM
Alpha Tau Provides 2026 Milestones and Clinical Updates at J.P. Morgan Healthcare Conference
DRTS
Product Launch
New Projects/Investments
Guidance Update
- Alpha Tau anticipates a potential approval in Japan for head and neck cancer imminently and expects to complete recruitment for pivotal trials in skin cancer, pilot studies in pancreatic cancer, and feasibility studies in glioblastoma during the first half of 2026, with data readouts in the second half of the year.
- The company is expanding its manufacturing capabilities with a new commercial facility in Hudson, New Hampshire, which recently completed its first construction phase and passed licensing requirements, targeting a total nameplate capacity of 15,000 patients per year when fully built and expected to provide U.S. commercial supply in 2026.
- Interim data from a study combining Alpha DaRT with Keytruda for metastatic head and neck squamous cell carcinoma showed a 100% systemic response and 50% complete response in treated patients, significantly outperforming Keytruda alone, with discussions ongoing with the FDA for a pivotal pathway.
- Alpha Tau reported having just under $76 million in cash at the end of Q3, with a historical cash burn of $5-$6 million per quarter, indicating sufficient capital to fund ongoing studies.
Jan 15, 2026, 7:15 PM
Alpha Tau Medical Highlights Key Milestones for a Transformational 2026
DRTS
Product Launch
New Projects/Investments
- Alpha Tau Medical anticipates imminent approval in Japan for head and neck cancer.
- The company expects to complete recruitment for its pivotal U.S. study in recurrent cutaneous SCC by the end of Q1 2026, with data anticipated later in 2026, leveraging breakthrough designation for a potential fast-track FDA review and modular PMA.
- Recruitment for the pancreatic cancer pilot study is expected to conclude around the end of Q1 2026, and the glioblastoma (GBM) feasibility study in the first half of 2026, with data from both expected in the second half of 2026.
- The first phase of Alpha Tau's new commercial manufacturing facility in Hudson, New Hampshire, has completed construction and passed licensing requirements, with the facility expected to provide commercial quantities for the U.S. in 2026.
Jan 15, 2026, 7:15 PM
Alpha Tau Medical Provides Updates on Clinical Trials, Manufacturing, and Financials
DRTS
New Projects/Investments
Product Launch
Guidance Update
- Alpha Tau Medical expects imminent approval in Japan for head and neck cancer and anticipates completing recruitment for its pivotal skin cancer trial, pilot pancreatic cancer study, and feasibility glioblastoma study in the first half of 2026, with data readouts expected in the second half of 2026.
- The company reported a strong financial position with $76 million in cash at the end of Q3 2025 and a historical cash burn of approximately $5-$6 million per quarter.
- The first phase of Alpha Tau's commercial manufacturing facility in Hudson, New Hampshire, has completed construction and passed licensing requirements, with plans to make commercial quantities of supply available for the U.S. in 2026 and a target capacity of 15,000 patients per year when fully built.
- Interim data from pancreatic cancer studies showed promising median overall survival rates, and a study combining Alpha DaRT with pembrolizumab (KEYTRUDA) for metastatic head and neck squamous cell carcinoma demonstrated systemic responses, with half of the treated patients achieving a complete response.
Jan 15, 2026, 7:15 PM
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