Alpha Tau Medical Sets Up Catalyst-Rich 2026 as Key Cancer Trial Data Nears

Key Points

• Alpha Tau Medical says 2026 will be a major catalyst year, with key trial readouts expected across skin cancer, pancreatic cancer, head and neck cancer, and glioblastoma programs.
• The company has completed treatment in its pivotal 88-patient U.S. skin cancer trial and expects data near year-end, while the FDA review is already underway through a rolling submission process.
• Early results are encouraging in other studies: the head and neck pembrolizumab combination data are due this summer, the pancreatic IMPACT trial was expanded to 40 patients, and initial glioblastoma data showed two complete responses among the first three patients.

Alpha Tau Medical NASDAQ: DRTS outlined a series of clinical and regulatory updates during the Lytham Partners Spring 2026 Investor Conference, with Raphi Levy of Alpha Tau telling investors the company’s most important trials are “coming to a head” over the coming months.

Levy said the company is focused on three key studies: ReSTART in recurrent cutaneous squamous cell carcinoma, the IMPACT pancreatic cancer trial in the U.S. and the REGAIN brain cancer study in the U.S. He described 2026 as a “very, very busy and catalyst-rich year” for the company.

Alpha Tau is developing a local alpha radiation delivery approach designed to be injected directly into tumors. Levy said the company’s Alpha DaRT technology uses a radioactive source coated with radium-224. As the radium decays, daughter products diffuse through the tumor and release alpha particles, with the goal of delivering a concentrated radiation dose inside the tumor while limiting exposure to surrounding healthy tissue.

Skin Cancer Trial Completes Treatment

Levy said Alpha Tau has completed treatment of all 88 patients in its pivotal U.S. trial for recurring squamous cell carcinoma skin tumors. The company expects data “towards the end of the year,” which it hopes to submit to the U.S. Food and Drug Administration for approval.

He noted that Alpha Tau has received FDA breakthrough designation for this cancer and has also been granted a rolling application process. Levy said the company has already begun submitting modules of the application and expects to continue doing so throughout the year.

“The goal is that by the time we get to the end of the year and have that clinical data from this study, we’ll already have much of the application behind us,” Levy said.

Levy also said Alpha Tau is already approved in Israel and, since its prior presentation with Lytham Partners, has been approved in Japan for treating head and neck cancers. He said the company is now focused on post-marketing surveillance requirements in Japan and is looking to start other trials there.

Head and Neck Combination Data Expected This Summer

Levy discussed Alpha Tau’s work exploring whether local treatment can generate an immune response and potentially affect tumors elsewhere in the body. He referenced prior animal and human evidence, including observations of T-cell activity and cases in which untreated tumors disappeared after another tumor was treated.

The company has studied Alpha DaRT in combination with Merck’s pembrolizumab, marketed as KEYTRUDA, in patients with recurrent unresectable or metastatic head and neck squamous cell carcinoma. Levy said the trial design was built around Merck’s KEYNOTE-048 study, with Alpha DaRT added into one tumor to evaluate whether untreated tumors elsewhere responded better than would be expected with KEYTRUDA alone.

According to Levy, interim data previously showed that three of eight patients, or three of six who were treated and measured, had a complete response, compared with an expected 5% systemic complete response rate for KEYTRUDA alone. He said final results from the study are expected to be presented this summer in a podium presentation at the American Head and Neck Society.

Levy said the company is discussing with the FDA a path to begin a larger U.S. study for approval in these patients, which would be Alpha Tau’s sixth U.S. study if approved.

Pancreatic Cancer Study Expanded

Alpha Tau is also advancing a pancreatic cancer program. Levy said prior interim data from first-in-human studies included metastatic patients who had failed first-line FOLFIRINOX. He said that while literature suggested expected survival of 10 to 11 months on FOLFIRINOX chemotherapy alone, most patients were still alive at a median follow-up of 15 months, and median survival had not yet been reached. Final results from that trial are being presented at ASCO 2026, according to Levy.

In the U.S., Alpha Tau’s IMPACT trial is evaluating newly diagnosed pancreatic cancer patients treated with chemotherapy together with Alpha DaRT. Levy said the company is studying whether adding a focused local dose directly into the pancreatic tumor can improve outcomes compared with chemotherapy alone without adding meaningful toxicity.

The trial was originally expected to include 15 patients in each cohort, for a total of 30 patients. Levy said the FDA recently expanded the study to 20 patients in each cohort, or 40 patients total, and widened eligibility to include patients receiving either FOLFIRINOX or gemcitabine and ABRAXANE, which he described as the two standards of care for these patients.

Levy said Alpha Tau expects to finish recruiting patients next quarter and expects data closer to the end of the year.

Early Glioblastoma Results Show Complete Responses

Levy highlighted recent early data from the company’s glioblastoma study at The Ohio State University in patients with recurrent GBM. He said the FDA initially allowed treatment of three patients, one per month, before reviewing interim safety data and deciding whether the company may treat seven additional patients.

Alpha Tau recently reported treatment responses from the first three patients. Levy said two of the three patients had a complete response, while the third had stable disease, with the tumor ending up 30% smaller than baseline. He cautioned that the data are early and more data are needed.

Levy described one patient who had experienced multiple recurrences after standard treatment, additional procedures and surgery. One month after Alpha DaRT treatment, Levy said imaging showed no visible tumor, and three months after treatment, the patient remained in complete response.

The only product-related side effects seen to date were seizures in patients who already had a history of seizures, Levy said, adding that they recovered with standard steroids or antiepileptics. Alpha Tau has submitted the interim data to the FDA and is awaiting feedback, with the goal of treating the remaining seven patients.

Cash Position and 2026 Milestones

Levy said Alpha Tau had $80 million in cash at the end of the previous quarter and remains financed for execution. He said the company’s burn rate has risen slowly as clinical trial activity has increased and is “probably approaching about $25 million a year now.”

Looking ahead, Levy said Alpha Tau expects skin cancer pivotal data toward the end of 2026, pancreatic cancer data around the end of 2026 or early 2027, and additional glioblastoma data later in the year if the FDA allows the study to continue enrolling the remaining patients.

About Alpha Tau Medical NASDAQ: DRTS

Alpha Tau Medical Ltd. is a medical technology company headquartered in Ness Ziona, Israel, focused on developing targeted alpha-radiation therapies for the treatment of solid tumors. The company's core innovation, known as Diffusing Alpha-emitters Radiation Therapy (DaRT), employs short-lived radioactive isotopes to deliver high-energy alpha particles directly within or adjacent to tumor tissues. By harnessing the potent cytotoxic effects of alpha radiation, Alpha Tau Medical aims to offer a novel approach to brachytherapy that can potentially overcome radioresistance and spare surrounding healthy tissue.

The company's lead product, Alpha DaRT, is currently being evaluated in clinical studies for a range of indications including recurrent or metastatic head and neck cancers, skin cancers, and other solid tumors.

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