Alpha Tau Successfully Treats First Patient in its U.S. Trial for Patients with Recurrent Glioblastoma at the James Cancer Hospital at The Ohio State University

Rhea-AI Summary

Alpha Tau (Nasdaq: DRTS) announced on December 9, 2025 that it treated the first patient in a U.S. pilot study of Alpha DaRT for recurrent glioblastoma multiforme (GBM) at The Ohio State University James Cancer Hospital.

The procedure used a novel intracranial delivery device integrated with standard brain navigation and reportedly achieved >95% tumor-volume coverage. The company noted FDA Breakthrough Device Designation and acceptance into the FDA Total Product Life Cycle Advisory Program to accelerate development for GBM patients.

Positive

• First-in-world intracranial Alpha DaRT patient treated (Dec 9, 2025)
• Delivery device achieved >95% tumor-volume coverage
• Received FDA Breakthrough Device Designation and advisory program acceptance
• Device integrates with standard brain navigation, easing surgical adoption

Negative

• Pilot study stage: no efficacy or safety outcomes reported yet
• Single-patient treatment indicates very early clinical evidence

Key Figures

Average GBM survival 8 months Estimated average survival rate for glioblastoma

GBM recurrence window 6–9 months Typical timeframe for rapid recurrences in GBM

Tumor coverage More than 95% Alpha DaRT sources coverage of tumor volume in first GBM brain case

Pancreatic trial size Up to 30 patients Planned enrollment in U.S. multi-center pancreatic cancer trial

Inoperable pancreatic cases 87% of newly diagnosed patients Target population considered inoperable in pancreatic program

Prostate pilot size Up to 12 patients Planned enrollment in recurrent prostate cancer Alpha DaRT study

Cash and deposits $75.9M Reported in Q3 2025 financial results

Nine-month net loss $30.5M Nine months ended Q3 2025 versus $22.3M prior year

Market Reality Check

$5.06 Last Close

Volume Volume 45,059 is at 0.71x the 20-day average of 63,091 shares before this news. normal

Technical Shares traded above the 200-day MA at $3.89 vs 200-day MA of $3.26 ahead of the announcement.

Peers on Argus 1 Up

Biotech peers showed mixed moves: ADCT -3.3%, ALDX +4.21%, AUTL +0.63%, IMRX +1.87%, TECX -1.33% while only TECX appeared on the momentum scanner, suggesting this GBM trial update was likely company-specific rather than part of a broad sector swing.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 04	Conference abstracts	Positive	+4.6%	ASCO GI pancreatic Alpha DaRT abstracts highlighting feasibility, safety and efficacy.
Dec 02	Regulatory IDE	Positive	+2.4%	FDA IDE approval for pilot Alpha DaRT study in locally recurrent prostate cancer.
Dec 01	Investor conferences	Neutral	-4.8%	December investor conference appearances and 1x1 meetings announcement.
Nov 20	Earnings update	Negative	-5.7%	Q3 2025 financials showing higher net loss alongside clinical and manufacturing progress.
Nov 11	Investor conference	Neutral	+0.5%	Participation at Jefferies Global Healthcare Conference with investor meetings.

Pattern Detected

Recent clinically focused news (trial starts and FDA IDEs) tended to see positive price reactions, while conference participation and earnings updates showed more mixed or negative responses.

Recent Company History

Over the past month, Alpha Tau reported several clinical and corporate milestones. On Nov 11 and Dec 1, conference participation news had muted to slightly positive price moves. The Q3 2025 update on Nov 20 highlighted expanded clinical activity and manufacturing capacity but coincided with a -5.71% move. In contrast, FDA IDE approval for recurrent prostate cancer on Dec 2 and ASCO GI pancreatic cancer abstracts on Dec 4 saw gains of 2.38% and 4.64%, respectively. Today’s GBM first-patient treatment continues this cadence of clinical execution.

Market Pulse Summary

The stock moved +8.7% in the session following this news. A strong positive reaction aligns with Alpha Tau’s recent pattern of favorable responses to clinical milestones, such as prior IDE approvals and trial updates with moves of 2.38% and 4.64%. The first-ever intracranial Alpha DaRT treatment for recurrent GBM underscores platform breadth. Investors would still need to weigh ongoing net losses of $30.5M over nine months and execution risks across multiple small pilot trials when assessing how durable such strength might be.

Key Terms

glioblastoma medical

"According to the National Brain Tumor Society, glioblastoma is one of the most"

Glioblastoma is a fast-growing and aggressive type of brain tumor that can affect a person's thinking, movement, or senses. Its seriousness and difficulty to treat can lead to significant health impacts, making it a concern for medical research and drug development. For investors, advances or setbacks in glioblastoma treatments can influence biotech companies and healthcare markets focused on cancer therapies.

glioblastoma multiforme medical

"pilot study for the treatment of patients with recurrent glioblastoma multiforme (GBM)"

An aggressive form of brain cancer that grows quickly and spreads into nearby brain tissue, often causing severe symptoms and limited treatment options. For investors, glioblastoma matters because it defines a high unmet medical need and a potentially large market for new drugs, devices, or diagnostics; success or failure in clinical trials and regulatory reviews for glioblastoma treatments can dramatically affect the valuation and risk profile of healthcare companies, like a make-or-break product for a small biotech.

breakthrough device designation regulatory

"supported by the FDA’s Breakthrough Device Designation and acceptance into the FDA’s"

A breakthrough device designation is a regulatory program that gives promising medical devices for serious or life‑threatening conditions priority support and faster review from a health authority (e.g., the U.S. FDA). Think of it as a “fast lane” or VIP pass through development and review: it can shorten time to market, lower regulatory uncertainty, and boost a company’s commercial prospects — but it is not an approval by itself.

intratumoral medical

"Intratumoral alpha-emitting radiotherapeutics such as Alpha DaRT offer a highly"

"Intratumoral" describes something that occurs or exists within a tumor, which is an abnormal growth of tissue. For investors, understanding intratumoral is important because it relates to medical treatments or research aimed at targeting the tumor directly, potentially leading to more effective therapies. Think of it as focusing treatment straight into the problem area, much like fixing a leak by working directly on the pipe itself.

alpha-emitting radiotherapeutics medical

"Intratumoral alpha-emitting radiotherapeutics such as Alpha DaRT offer a highly"

Alpha-emitting radiotherapeutics are cancer treatments that attach tiny sources of high-energy radiation to molecules that home in on tumor cells, delivering powerful, short-range damage much like a precision bullet that stops after a few cells. Investors should watch them because successful drugs can command premium pricing, unlock new treatment markets, and carry unique manufacturing, regulatory and safety risks that affect development timelines, costs and commercial potential.

neurosurgical medical

"delivery system designed specifically to integrate seamlessly into a standard neurosurgical workflow"

Relating to surgery on the brain, spinal cord, and related nerves, neurosurgical describes procedures, tools, devices, and specialties that repair, remove, or treat disorders of the nervous system. Investors care because neurosurgical products and procedures often command high prices, require lengthy testing and approvals, and can drive durable revenue if clinically successful—think of them as precision repairs on a complex computer where a successful fix can justify large long-term returns but carries high technical and regulatory risk.

neuro-oncology medical

"great scientific and clinical significance for the entire field of neuro-oncology."

Neuro-oncology is the medical field that studies and treats tumors of the nervous system, especially the brain and spinal cord. For investors, it matters because advances or setbacks in neuro-oncology research, drug development and clinical trials can strongly affect the value of healthcare and biotech companies—think of it like repairing delicate circuitry: successful treatments can unlock big market opportunities, while failures or delays can reduce expected returns.

AI-generated analysis. Not financial advice.

- First patient in the world treated with Alpha DaRT^® in the brain –

- According to the National Brain Tumor Society, glioblastoma is one of the most complex, deadly, and treatment-resistant cancers, with an estimated average survival rate of only 8 months –

- This pilot study is a key part of Alpha Tau’s broader strategy to bring Alpha DaRT to cancer patients with some of the highest unmet needs -

JERUSALEM, Dec. 09, 2025 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT^® today announced that the first patient has been treated in its pilot study for the treatment of patients with recurrent glioblastoma multiforme (GBM) using the Alpha DaRT technology.

Uzi Sofer, CEO of Alpha Tau, stated, “This is a historic day for Alpha Tau and for GBM patients around the world, with the first treatment ever of a brain cancer using Alpha DaRT. Given the devastating prognosis of GBM, and its high rate of rapid recurrences, generally within 6-9 months, there is a desperate need for new local therapies with an appropriate safety profile for such a critical and sensitive area like the brain. This pilot study is a key part of our broader strategy to bring Alpha DaRT to cancer patients with some of the highest unmet needs, supported by the FDA’s Breakthrough Device Designation and acceptance into the FDA’s prestigious Total Product Life Cycle Advisory Program designed to accelerate the Alpha DaRT treatment to market and to GBM patients who may stand to benefit greatly.”

The first patient was treated at The Ohio State University Center in Columbus, Ohio, by a multidisciplinary team led by Principal Investigator and Radiation Oncologist Joshua D. Palmer, MD, Medical Physicist Michael Degnan, MS, DABR and Neurosurgeon J. Bradley Elder, MD, using a novel delivery approach designed specifically for intracranial use.

Dr. Joshua Palmer, commented: “Patients with recurrent glioblastoma face one of the most difficult cancer diagnoses in medicine. There is an urgent unmet need for new therapeutic approaches that can be delivered locally while minimizing harm to surrounding healthy brain tissue. Intratumoral alpha-emitting radiotherapeutics such as Alpha DaRT offer a highly compelling novel scientific approach by delivering potent, short-range radiation precisely where it is needed most.”

Dr. J. Bradley Elder, who led the procedure with Dr. Palmer, added: “From a technical standpoint, this procedure demonstrated excellent feasibility. The novel delivery device allowed us to place the Alpha DaRT sources in a precise radial configuration that achieved more than 95% coverage of the tumor volume. Importantly, the system integrates seamlessly as an add-on to the standard brain navigation platform that I use routinely in surgery, making it simple to adopt without disrupting existing workflow.”

“This achievement represents the culmination of many years of dedicated teamwork within Alpha Tau - including extensive preclinical research, developing a unique delivery system designed specifically to integrate seamlessly into a standard neurosurgical workflow and, of course, partnership with our wonderful clinical collaborators at OSU,” commented Dr. Robert Den, Chief Medical Officer of Alpha Tau. “This is a transformational patient-centric moment of great scientific and clinical significance for the entire field of neuro-oncology.”

About the Study

The clinical trial is expected to enroll up to ten U.S. patients with recurrent glioblastoma not amenable for surgical resection who have undergone a prior course of central nervous system radiation. The primary objective of the study is to evaluate the feasibility and safety of the treatment, following the Company’s promising results from pre-clinical studies. Additional information about the trial can be found at https://www.clinicaltrials.gov/study/NCT06910306

About Alpha Tau Medical Ltd. 

Founded in 2016, Alpha Tau is an Israeli oncology therapeutics company that focuses on research, development, and potential commercialization of the Alpha DaRT for the treatment of solid tumors. The technology was initially developed by Prof. Itzhak Kelson and Prof. Yona Keisari from Tel Aviv University.

About Alpha DaRT^®

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.

Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. When used herein, words including “anticipate,” “will,” “plan,” “may,” “continue,” and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to the Alpha DaRT treatment in GBM patients, including the expected patient enrollment, benefits, safety, implementation, feasibility and go to market process, and other expectations, beliefs, plans, including with respect to clinical trials, regulatory approvals and studies, are forward-looking. All forward-looking statements are based upon Alpha Tau’s current expectations and various assumptions. Alpha Tau believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Alpha Tau may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation: (i) Alpha Tau’s ability to receive regulatory approval for its Alpha DaRT technology or any future products or product candidates; (ii) Alpha Tau’s limited operating history; (iii) Alpha Tau’s incurrence of significant losses to date; (iv) Alpha Tau’s need for additional funding and ability to raise capital when needed; (v) Alpha Tau’s limited experience in medical device discovery and development; (vi) Alpha Tau’s dependence on the success and commercialization of the Alpha DaRT technology; (vii) the failure of preliminary data from Alpha Tau’s clinical studies to predict final study results; (viii) failure of Alpha Tau’s early clinical studies or preclinical studies to predict future clinical studies; (ix) Alpha Tau’s ability to enroll patients in its clinical trials; (x) undesirable side effects caused by Alpha Tau’s Alpha DaRT technology or any future products or product candidates; (xi) Alpha Tau’s exposure to patent infringement lawsuits; (xii) Alpha Tau’s ability to comply with the extensive regulations applicable to it; (xiii) the ability to meet Nasdaq’s listing standards; (xiv) costs related to being a public company; (xv) changes in applicable laws or regulations; and the other important factors discussed under the caption “Risk Factors” in Alpha Tau’s annual report filed on form 20-F with the SEC on March 12, 2025, and other filings that Alpha Tau may make with the United States Securities and Exchange Commission. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While Alpha Tau may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing Alpha Tau’s views as of any date subsequent to the date of this press release.

Investor Relations Contact: 

IR@alphatau.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/71cc88b1-7458-45c0-8793-6d5c1cb1068f

FAQ

What did Alpha Tau announce on December 9, 2025 about DRTS and glioblastoma?

Alpha Tau announced the first U.S. patient treated with Alpha DaRT for recurrent GBM at The Ohio State University on December 9, 2025.

Where was the first Alpha DaRT intracranial procedure for DRTS performed?

The first intracranial Alpha DaRT procedure was performed at The Ohio State University James Cancer Hospital in Columbus, Ohio.

What tumor coverage did the Alpha DaRT delivery device achieve in the DRTS procedure?

The novel delivery device achieved reported tumor coverage of more than 95% of the tumor volume.

Does Alpha Tau (DRTS) have any FDA designations for Alpha DaRT in GBM?

Yes. Alpha DaRT has FDA Breakthrough Device Designation and was accepted into the FDA Total Product Life Cycle Advisory Program.

Who led the multidisciplinary team for Alpha DaRT's first U.S. GBM treatment (DRTS)?

The procedure team was led by Principal Investigator and radiation oncologist Joshua D. Palmer, MD, with neurosurgeon J. Bradley Elder, MD and medical physicist Michael Degnan, MS, DABR.