Alpha Tau Medical Ltd (DRTS)

Alpha Tau Successfully Treats First Recurrent Glioblastoma Patient Outside of the United States

https://www.alphatau.com/single-post/alpha-tau-successfully-treats-first-recurrent-glioblastoma-patient-outside-of-the-united-states-with

Finance Herald article--GOOD read

https://thefinanceherald.com/a-brain-cancer-win-got-the-headlines-this-small-cap-has-four-more-cancers-in-the-clinic-nasdaq-drts/

Merlin Trader update

https://www.merlintrader.com/alpha-tau-stock-hub/

Dart article in Irish magazine White Rose

https://whiterosemagazine.com/a-dart-punctures-bds-in-dublin/

Should be hearing an update on this any day now
The Glioblastoma trial
The Announcement Date:
Alpha Tau officially announced the groundbreaking interim results and the regulatory push on May 11, 2026.
Because Alpha Tau holds an FDA Breakthrough Device designation and is part of the FDA's Total Product Lifecycle Advisory Program (TAP) for this indication, the agency is expected to expedite its response within 30 days of the submission.


Kiwi

Link / recognition in Your Cancer Path

https://www.yourcancerpath.com/#pancreatic/promising

THANKS to Your Cancer Path for recognizing

Agree ...invest in the best altho DRTS is probably a lot more speculative .
Good luck
Kiwi

Hi Kiwi. Did the same a few min ago. Still dropping. After having sold RVMD a few days back I jumped back in today. Both companies have treatments that are the cream of the crop. Whether that really means anything who knows, but they say invest in the best.

Buying more at $9.5 .. Sell off seems related to over all market weakness and CFO selling some of his shares
02:32 PM EDT, 06/04/2026 (MT Newswires) -- Raphi Levy, Chief Financial Officer, on June 03, 2026, sold 32,500 shares in Alpha Tau Medical (DRTS) for $352,115. Following the Form 4 filing with the SEC, Levy has control over a total of 147,680 ordinary shares of the company, with 147,680 shares held directly.


He probably has a lot of options or RSU's that vest in the future and if I have time later , might chk .
By the 11th , we should know if FDA OK's more patients for the Glioblastoma study

About the REGAIN Study

The REGAIN study is a prospective, open-label, single arm interventional study designed to evaluate the feasibility and safety of Alpha DaRT for the potential treatment of recurrent glioblastoma.

The clinical trial is expected to enroll up to ten U.S. patients with recurrent GBM 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



Kiwi

BENZINGA
Jun-04-2026 8:58 a.m. ET
Barclays analyst Lukas Shumway maintains Alpha Tau Medical (DRTS) with a Overweight and raises the price target from $15 to $17.

Yep was thinking the same thing and also thinking the sp should rise to that 

Interesting At closing, Tolmar will make a $20M equity investment in Alpha Tau at $11.99 a share,

Kiwi

Strategic collaboration announcement:

Alpha Tau and Tolmar Announce Strategic Collaboration to Bring Alpha DaRT® Therapy to U.S. Urological Cancer Patients
GLOBENEWSWIRE
Jun-03-2026 8:30 a.m. ET
- Joint partnership leverages Alpha Tau’s highly potent, localized alpha-radiation technology and Tolmar’s commercial leadership to transform the U.S. uro-oncology landscape
- Collaboration elevates prostate cancer as a core strategic focus, backed by Tolmar’s initial $15M manufacturing investment, $20M equity infusion at $11.99 per share (25% premium to 30-day VWAP), and up to $161.5M in clinical, regulatory and commercial milestones for the first indication
- Agreement grants Tolmar exclusive U.S. commercialization rights for prostate cancer, with an option to expand into bladder cancer subject to additional payments
- Alpha Tau to manufacture Alpha DaRT for Tolmar’s commercialization, to be sold to Tolmar at 60% of the onward net sales price, subject to certain adjustments
JERUSALEM and DUBLIN, June 03, 2026 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. (DRTS) , developer of the innovative alpha-radiation cancer therapy Alpha DaRT®, and Tolmar International Ltd., one of the strongest commercial players in the U.S. urology, oncology, endocrinology and pediatric endocrinology markets, today announced a strategic collaboration agreement to develop and commercialize Alpha DaRT for the treatment of prostate cancer in the United States.
According to the American Cancer Society, prostate cancer is the second-leading cause of cancer death in American men, behind only lung cancer, with over 330,000 new cases expected this year and about 1 in 44 men dying from the disease. More than half of men who undergo a radical prostatectomy experience long-term complications, including erectile dysfunction and urinary incontinence, highlighting the need for new alternatives that may potentially avoid such surgeries.
Through the collaboration, Tolmar will hold exclusive rights to commercialize Alpha DaRT in the United States for prostate cancer indications for a term that is expected to extend for 20 years from first commercial sale, subject to the terms and conditions of the Collaboration Agreement. Tolmar also holds an option, exercisable upon achievement of specified clinical criteria, to expand commercially into bladder cancer in the United States.
Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) represents a paradigm shift in the treatment of solid tumors. While traditional radiation therapies face limitations of efficacy and focused targeted delivery, Alpha DaRT is designed to deliver highly potent and conformal therapy directly inside the tumor, by means of recoiling radioisotopes that release alpha particles with high energy and short diffusion. Alpha DaRT therefore has the potential to destroy cancer cells with precision and spare the surrounding healthy tissue, offering patients a new and highly localized treatment modality to maximize their quality of life.
Alpha Tau Chief Executive Officer, Uzi Sofer, remarked, “Our clinical exploration of prostate cancer is already well underway, having treated patients in Israel and secured an IDE from the FDA for a U.S. trial. Working alongside Tolmar, a top commercial leader with a keen understanding of this market, unlocks a vital channel with the potential to reach tens of thousands of patients per year in this first urological indication alone. Alongside our core clinical programs to date in glioblastoma, pancreatic cancer, and squamous cell carcinoma, expanding into prostate cancer allows us to extend the reach of our platform technology exponentially and builds upon our deep commitment to advancing innovative therapies across multiple oncology settings. This partnership will also spur additional expansion of our U.S. manufacturing capacity, advancing our commitment to deliver this groundbreaking science to patients as quickly as possible.”
“Alpha DaRT represents a meaningful advancement in oncology, with the potential to make a significant difference for patients facing prostate cancer," said Anil D’Souza, Chief Executive Officer of Tolmar. "By combining innovative science with Tolmar’s proven capabilities and deep experience supporting providers, we are focused on expanding access to new treatment options for patients and the clinicians who care for them. Throughout our extensive due diligence of Alpha Tau, we were consistently impressed with Uzi and the talent of the Alpha Tau leadership team, thinking strategically through all aspects of this unique therapy, from manufacturing to supply chain, and into clinical settings, as we were increasingly convinced of the promise of the technology, the market opportunity, and the commercial prospects. Together, we are mobilized to work to accelerate its development and bring this therapy to patients across the United States as efficiently as possible.”
Tolmar Chief Medical Officer, Anjan Chatterjee, MD, MPH, MBA, added, “From a clinical perspective, Alpha DaRT’s localized mechanism of action is incredibly promising for urological oncology. For clinicians treating prostate cancer, the ability to deliver potent alpha-radiation precisely to the tumor while minimizing radiation-induced damage to nearby healthy tissue (off-target activity) can address a profound unmet medical need. We are eager to collaborate with Alpha Tau's medical team to advance the U.S. clinical development program and bring this solution to patients and their physicians in the oncology community.”
Alpha Tau Chief Financial Officer, Raphi Levy, commented, “We are very excited about the potential for this collaboration. We have long identified the prostate cancer market as compelling, and with our concentration also on other cancers, we stand to benefit greatly from Tolmar’s focus and deep industry expertise in this sector, and we will be excellently positioned towards introducing a much-needed therapy in a seamless and integrated fashion. It has been a pleasure working with Tolmar to get to this moment, though we know the work is only just beginning.”
Key Terms of the Collaboration
Tolmar will hold exclusive rights to commercialize Alpha DaRT in the United States for prostate cancer indications for a term that is expected to extend for 20 years from first commercial sale, subject to the terms and conditions of the Collaboration Agreement. Tolmar also holds an option to expand the agreement to include bladder cancer commercialization in the U.S., exercisable upon achievement of specified clinical criteria.
Alpha Tau will lead clinical development of the Alpha DaRT for these indications, working in close collaboration with Tolmar and subject to joint governance under the collaboration agreement. Alpha Tau will be responsible for manufacturing and supply of the product, while Tolmar will have full responsibility and control over commercialization, including pricing, customer engagement, and sales execution in the United States. The supply price to Tolmar is based on a percentage of net sales (set at 60%, subject to certain adjustments as defined in the Supply Agreement).
At closing, Tolmar will make a $20M equity investment in Alpha Tau at $11.99 a share, a 25% premium to the 30-trading day volume-weighted average price (VWAP) prior to signature, and will pay $15M towards the construction of a new Alpha DaRT production facility in the U.S. Certain payments have also been agreed for future clinical development and U.S. regulatory approval work, which total up to $96.5M in development and regulatory milestone payments for the initial indication, and up to $65M in commercial milestone payments, subject to achievement of specified milestones.
Should Tolmar exercise the U.S. bladder cancer option, Tolmar will invest another $5M at a 25% premium to the then-prevailing 30-trading day VWAP and pay an additional $5M for expanded manufacturing capacity, as well as similar payments of up to $96.5M for future clinical development and U.S. regulatory approval work for the first bladder cancer indication to be pursued jointly by the parties.
Under the terms of the agreement, Tolmar receives a right of first negotiation on new Alpha Tau products for U.S. urological cancers covered by the agreement, as well as a right of first negotiation for certain additional products and geographic opportunities, as specified in the Collaboration Agreement. Alpha Tau retains all rights to Alpha DaRT outside of the prostate and bladder markets in the U.S., as well as all global rights outside the U.S.
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 Tolmar
Founded in 2007, Tolmar is a specialty pharmaceutical company focused on developing and commercializing products that address unmet needs in urology, oncology, endocrinology and pediatric endocrinology. Driven by a passion for advancing patient care and improving outcomes, Tolmar is committed to supporting healthcare providers with the education, tools, and therapies needed to deliver high-quality, evidence-based care. Guided by core values rooted in accountability, ethical conduct, continuous improvement, and a deep commitment to people, Tolmar operates with a proactive and agile approach to innovation and partnership. To date, the company has produced 22 marketed products supported by five New Drug Applications (NDAs) and 17 Abbreviated New Drug Applications (ANDAs) across its key therapeutic areas.
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, including feasibility and go to market process, and other expectations, beliefs, plans, including with respect to clinical trials, regulatory approvals and market entry, 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 9, 2026, 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.
Alpha Tau Investor Relations Contact:
IR@alphatau.com
Tolmar Media Relations Contact:
media@tolmar.com

HC Wainwright & Co. Reiterates Buy on Alpha Tau Medical, Maintains $15 Price Target
Benzinga · Jun-02-2026 12:40 PM ET
HC Wainwright & Co. analyst Yi Chen reiterates Alpha Tau Medical (DRTS.NaE) with a Buy and maintains $15 price target.

FWIW

Kiwi

Not too thrilled by the last couple of days of trading, but just picked up some more shares. Not a big proponent of charts, but looking at one, it looks to have come down today to fill the gap, so who knows. Sold my RVMD this morning in premarket so kinda lucky there.

Very positive if the FDA allows them to proceed, negative if they don’t.  I may not know very much, but in my mind considering the results in the first 3 patients, I can’t see any way the FDA could turn them down. Hope not to be proven wrong. 

Should be able to continue. This is RECURRENT GBM. The options are _______.??

The FDA has been plenty careful only allowing 1 patient / month to be treated for first 3 patients. Hopefully this gets lifted??
Of those 3 patients (all male)--1 had 3 recurrences and 1 had 2 recurrences. geez

The filed on May 11th . Due to the agreement they have with the FDA ...FDA will try and respond within 30 days ( June 11th ) as to whether or not the FDA allows them to continue the trial with more patients receiving the Alpha Tau dart .

Alpha Tau Medical (NASDAQ: DRTS) submitted its interim safety data report to the FDA in early May 2026.
The submission followed the May 3, 2026 data cutoff date for the first three patients treated in the REGAIN trial for recurrent glioblastoma.
As of late May 2026, the company confirmed that the report had been submitted and they are currently awaiting FDA feedback to secure authorization to expand enrollment to the remaining seven patients in the study.
Because the REGAIN program carries an FDA Breakthrough Device designation, the agency's response window is expected to be streamlined within approximately 30 days.

Kiwi

Don't want to sound like I am dense, but did they file the submission on May 11 or just talk about it then?

I had to look up what "enhanced tumor" meant. It basically is the most active part of the tumor and the part that lights up on a contrast MRI.

This sentence of the press release along with data showing 2 out of the 3 patients had total remission and the third had their lesion reduced by 30% and considered to have stable disease, I thought was truly mind blowing:

A 2023 meta-analysis of treatments available for recurrent GBM found objective response rates ranging from 3.4% for biologic agents and 6.1% for chemotherapies to 26.8% for antiangiogenic therapies, but nothing approaching the responses we’ve seen so far to Alpha DaRT.

The Glioblastoma trial
The Announcement Date:
Alpha Tau officially announced the groundbreaking interim results and the regulatory push on May 11, 2026.
Because Alpha Tau holds an FDA Breakthrough Device designation and is part of the FDA's Total Product Lifecycle Advisory Program (TAP) for this indication, the agency is expected to expedite its response within 30 days of the submission.

Kiwi

The Glioblastoma trial
The Core Details
The interim safety analysis—conducted at the request of the FDA—evaluated the first three patients treated in the REGAIN trial.

Glioblastoma is an exceptionally aggressive, treatment-resistant brain cancer with a historic median survival rate of just a few months upon recurrence.

The Patients:
The individuals were treated between December 2025 and March 2026 at The Ohio State University Comprehensive Cancer Center (OSUCCC – James).

The Results:
As of the May 3, 2026 data cutoff, the trial achieved a 100% local disease control rate.
Two patients experienced a complete response (67% CR rate) with the complete disappearance of tumor lesions on multiple MRI scans.
The third patient maintained stable disease with a 30% reduction in tumor dimensions.

Safety Profile:
No local or distant tumor recurrences were observed, and no lingering procedure-related symptoms occurred.
Only one Grade 3 serious adverse event (SAE) was reported, which was quickly and successfully resolved using standard steroids.

The Technology: Alpha DaRT®
The treatment utilizes Alpha Tau's proprietary Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) system

.Mechanism:
Radium-224 impregnated sources are delivered directly inside the solid tumor.
Targeted Destruction: As the radium decays, it releases short-lived isotopes that travel short distances, emitting high-energy alpha particles.

Sparing Healthy Tissue:
Because alpha radiation has a highly destructive but ultra-short path length, it kills the localized tumor cells while leaving the surrounding healthy brain tissue virtually unharmed.

Medical Context & Next Steps
Principal investigators highlighted that these early results are historically unprecedented for recurrent GBM.

Conventional therapies—like biologic agents or chemotherapies—typically yield objective response rates of only 3% to 6% in this patient population.
Following the submission and review of this mandatory safety report, Alpha Tau aims to secure FDA confirmation to continue enrolling the remaining cohorts for the REGAIN trial.
This brain cancer study is running alongside several other concurrent U.S. programs for Alpha Tau, including advanced trials in skin, prostate, and pancreatic cancers.
---------------------
The FDA will decide by mid June if this trial can continue .

High risk investment as stock will likely get crushed if FDA decides not to allow them to proceed. .
I think odds heavily favor the FDA allowing them to proceed.

Kiwi

Thx but an earlier catalyst may be the following re their Glioblastoma data

Alpha Tau Medical (DRTS) expects to hear back from the FDA within 30 days of their formal interim data submission, which took place in mid-May 2026.

This rapid turnaround is due to the Alpha DaRT program's FDA Breakthrough Device designation, which mandates expedited agency responses.

Timeline for Additional Glioblastoma DataIf the FDA reviews the safety report and formally allows the REGAIN trial to continue:

Initial FDA Feedback:
Expected by mid-June 2026 (30 days from the May 11 presentation and submission)

.Study Accrual:
The approval will allow DRTS to immediately begin enrolling and treating the remaining 7 patients in the 10-patient pilot study.

Additional Data Readout:
Management anticipates that additional glioblastoma data will be available later in 2026.

Final Pilot Results:
Chief Medical Officer Robert Den noted that final data from the REGAIN study is usually reported 3 to 4 months after the last patient is enrolled.
Context of the REGAIN Study
Interim DataCurrent Status:
On May 11, 2026, DRTS released highly positive interim safety and efficacy data from the first 3 treated patients.
Results:
The trial demonstrated 100% local disease control, with two patients showing a complete response (total disappearance of tumor lesions) and one showing stable disease with a 30% reduction.

Next Regulatory Milestone:
If the safety profile trends hold up through the end of the 10-patient pilot, the company is aiming to use the late-2026 data to request permission from the FDA to launch a pivotal trial before the end of the year (EOY).

This is key
The approval will allow DRTS to immediately begin enrolling and treating the remaining 7 patients in the 10-patient pilot study
They need this go ahead ....by mid June 2026
JMO

Kiwi

Should be interesting data coming end JUL--they got accepted for podium presentation at the head and neck cancer conf. AHNS

It will be top line data showing results in combo therapy w Pembrolizumab

Yep disappointed.  I even added a bit more today but will hold as well. 

Well looks like "sell the news " behavior as the Reddit and Fox Business news crowd bail .
Co has $80m cash on hand so a capital raise near term looks unlikely ..but who knows .

I'm not selling .
I'll hold thru to the IMPACT data ....due at end of year
JMO
Kiwi

You found the quote I was looking at.  Earlier today I would have been chomping at the bit to get in lower but now I am worried that I should be unloading.  See if a night’s sleep clears my mind. 

What overnight market are you referring to ?
The risk for DRTS is that this is early data with a very small number of patients .
RVMD's P 3 was 500 patients ...its a whole different ball game .
Yes maybe excellent RVMD data reduces the appeal of DRTS's approach ...but I'm still thinking we end up with both if DRTS maintains good/ safe data

Found it
Alpha Tau Medical Ltd. (DRTS) is trading at $10.29 during the current overnight session on the Blue Ocean ATS. This price reflects a 4.99% decrease (-$0.54) from its last standard market closing price of $10.83

Revolution Medicines Inc. (RVMD) is trading at $184.45 on the overnight market, representing a major surge of +$26.97 (+17.13%) from its previous regular market close of $157.48.
JMO
Kiwi

Usually meaningless but wonder why at this hour DRTS down in overnight markets.  Wonder if data released by RVMD is overshadowing and hurting DRTS

Might have to go the DRTS route as I found out a child can only have one Trump account at a time. 

Thanks.  I am going to have to look up how many Trump accounts the kid can have.  My son was telling me that he would have to get one for her because his company will also contribute - can’t remember if he said 1K or 2K. 

RMB. The podium presentation is in July for the Head and Neck cancer conference ( I think ) .
The big data will be the IMPACT trial data at end of year .
Probable buy ops will arise ...otherwise its staying up till extended hrs opens for some ...1 am in your left coast time .
Meanwhile ...for your new granddaughter ...sign her up for the new Trump account and match the first $1,000 with $1,000 from you .
Left alone compounding at the history of what the S & P compounds at ..If you invest $2,000 in the S&P 500 today, it will grow to approximately $14,800.50 in 21 years, assuming it compounds at its long-term historical nominal average of 10% per year.

Or $1,000 from Trump and $4,000 from you to start the Trump account
$5,000 compounded annually at 10% for 21 years equals $37,001.25.
Of course inflation will mean less purchasing power .

OR. just buy her some DRTS with instructions she can't sell it , or the Co that buys them ,,,until she is 21


Kiwi

DRTS Corporate PowerPoint May 2026 Link: https://www.alphatau.com/_files/ugd/b7ea83_5de7e6e77497405f883de05ca1f60316.pdf

DRTS "Alpha Tau Medical Featured on Fox Business Discussing Disruptive Oncology Tech Ahead of ASCO 2026,"
https://www.linkedin.com/posts/alphataumedical_fox-business-said-it-right-asco-2026-is-activity-7466758535046062081-YQrp?utm_source=share&utm_medium=member_android&rcm=ACoAAAA_XNABEmb8syG9zxO2y7P7Hbfu39Q5aLQ

Kiwi, thanks for putting all that information together. So far the data looks very good. With that good data I am still surprised that analyst targets are not very high. Looking for to the podium presentation - tomorrow or Tuesday.

Just scratching my head this weekend wondering whether it is too late to add more shares....

Alpha Tau Medical (NASDAQ: DRTS) is currently running several concurrent cancer trials for its alpha-radiation therapy, Alpha DaRT, with major data readouts and milestone timelines scheduled throughout 2026.

The targeted readout timelines vary by the specific cancer indication:

1. Pancreatic Cancer (IMPACT Trial)
Readout Timeline:
Initial data anticipated by year-end 2026.
Current Status:
This U.S. multi-center trial evaluates Alpha DaRT combined with chemotherapy.
Recruitment was expanded and targeted for completion in Q1/Q2 2026.
Recent Updates:
Separate pooled data from its international pancreatic trials was just presented at DDW 2026 (May 2026), showing a 100% local disease control rate. Final safety/efficacy abstracts are also being featured at the 2026 ASCO Annual Meeting (May 29 - June 2, 2026).

2. Brain Cancer / Recurrent Glioblastoma (REGAIN Trial)Readout Timeline: First full results around the end of 2026.
Current Status: This trial recently released groundbreaking interim safety results from its first three patients on May 11, 2026, showcasing a 67% complete response rate and 100% local disease control.
Following this successful safety analysis, recruitment is expanding to a 10-patient cohort across New York and Houston locations.

3. Skin Cancer (ReSTART Pivotal Trial)Readout Timeline: Data readout and potential FDA submission expected in H2 2026.Current Status: Evaluating recurrent cutaneous squamous cell carcinoma (cSCC).
Patient enrollment was successfully completed in early 2026. Alpha Tau has already initiated its modular Pre-Market Approval (PMA) submission to the FDA for this indication.

Kiwi. with AI assist

The newly published pooled clinical data for Alpha DaRT® in advanced pancreatic adenocarcinoma, officially released via the ASCO Abstract Presentation, shows highly promising efficacy signals and strong safety markers.

The results are particularly impressive given that the data tracks 58 heavily pre-treated, late-stage patients who had very limited therapeutic options left.

Here is the breakdown of how the data stacks up against historical expectations:

Efficacy & Local Tumor Control87% Disease Control Rate (DCR):
Out of the evaluable patients, the vast majority achieved local disease stabilization or tumor shrinkage.27%

Objective Response Rate (ORR): This included 3 complete responses (total tumor disappearance) and 9 partial responses.

For advanced pancreatic cancer, any complete response is rare and considered a major win.

100% Target Lesion Control:
Earlier localized subsets from these trials presented at Digestive Disease Week (DDW 2026) confirmed that 0% of patients experienced disease progression in the specific primary lesion injected with the alpha-radiation seeds.

Survival MetricsMedian Overall Survival (OS): The median OS across the entire advanced cohort was 7.9 months.

Second-Line Outperformance:
For patients who received Alpha DaRT as a second-line therapy (mostly following first-line FOLFIRINOX failure), the median OS jumped to 10.4 months.
This notably beats the historical real-world benchmark for post-FOLFIRINOX survival, which typically hovers around 3 to 6 months without chemotherapy.

Third-Line Durability:
Even in highly advanced, third-line patients, the median OS reached 7.5 months.

Safety ProfileLow Severe Adverse Events:
Treatment-associated adverse events (AEs) occurred in 36% of patients. Crucially, severe Grade \(\ge \) 3 adverse events occurred in only 9% of the cohort (5 patients), consisting of manageable complications like biliary obstruction, fever, and abdominal pain.Zero Treatment-Related Deaths:

All severe adverse events were fully resolved, proving that internal alpha-radiation can be delivered directly to the pancreas via endoscopic ultrasound without damaging surrounding critical tissue.Context & LimitationsWhile the data has driven significant investor optimism, medical experts note that this is still a pooled analysis of early-stage, non-randomized pilot studies.

The ultimate test for Alpha Tau will be their ongoing, larger-scale trials, such as the U.S. multi-center IMPACT trial, which combines Alpha DaRT directly with standard frontline chemotherapies.

Via AI
Kiwi

AI analysis of the ASCO data you linked

The 27% Objective Response Rate (ORR) and 87% Disease Control Rate (DCR) presented by Alpha Tau Medical (NASDAQ: DRTS) at the 2026 ASCO Annual Meeting are extraordinarily strong because they represent a highly challenging, heavily pre-treated patient population.

This data stems from a pooled analysis of 58 patients across three prospective clinical studies in Canada and Israel evaluating Alpha DaRT—an endoscopic ultrasound-guided, intratumoral alpha-radiation therapy.

Why These Specific Results Matter
Heavily Pre-treated Population:
The patients in these trials are typically "refractory," meaning they have already tried and failed aggressive standard-of-line chemotherapies (like FOLFIRINOX). In this second- or third-line setting, standard chemotherapy usually yields an ORR of just 5% to 15% and a DCR of 40% to 60%.

Beating the Benchmarks:
Reaching a 27% ORR means DRTS is nearly tripling the tumor shrinkage expectations for advanced, resistant pancreatic cancer.

Meanwhile, an 87% DCR indicates the vast majority of patients saw their disease halt or reverse.

Local vs. Systemic Impact:
Earlier readouts from this dataset at Digestive Disease Week (DDW) 2026 showed a 100% local disease control rate in the targeted tumors.
The 87% overall DCR tells us that this local control is successfully translating into global disease stabilization across the body.

The Clinical Advantage:
Immune PreservationTraditional, external-beam radiation therapy often destroys local immune cells and degrades the patient's immune system, which is a known negative prognostic indicator in pancreatic cancer.

According to data published by Alpha Tau Medical, Alpha DaRT behaves differently:Intratumoral Precision: It delivers highly destructive alpha particles directly into the tumor center, traveling only a fraction of a millimeter to spare healthy tissue.

Immune System Preservation:
Biomarker data confirms that it preserves local immune function and induces a potential anti-inflammatory environment.

The Ultimate Test: Survival Data
Because these efficacy numbers are so high, oncology experts at ASCO 2026 are heavily focused on the corresponding overall survival (OS) metrics.

For context, patients who fail first-line FOLFIRINOX historically have a median survival of roughly 6 to 10 months.

If DRTS' final ASCO presentation confirms that this 87% disease control translates to a significant survival extension, Alpha DaRT will likely be viewed as a major breakthrough apparatus for solid tumors.

Kiwi

Thx ..thought this was coming out on Monday .
Thx for the link
Kiwi

ASCO PANC survival data

With AI assist
Lagging Analyst Updates vs. Recent Rallies
Several institutional targets have been steadily adjusted upward, but they are still playing catch-up to the live ticker.
While some updates are conservative, top-tier institutions have issued higher targets:

H.C. Wainwright: Maintained a $15.00 price target
.Barclays: Initiated coverage with an Overweight rating and a $15.00 target
.Ladenburg Thalmann: Recently bumped their target up to $14.00
.Piper Sandler: Remains the street low drag, historically capping expectations by only upgrading their target from $5.00 to $8.00 with a Neutral stance.3.

Commercialization and Safety Hurdles
Biotech analysts price their financial models using heavily discounted cash flows to account for execution risks.
Concerns tempering the absolute ceiling of these short-term targets include:

Near-Term Revenue Limitations:
Analysts cite the company's lack of significant near-term revenue generation and profitability.

Validation Needs:
The company still faces feasibility and safety milestones, along with the ongoing requirement to validate early-stage findings in larger, multi-site human clinical trials.

Warrant and Share Dilution:
Profitable lock-ins and potential warrant exercises from major institutional stakeholders (such as Oramed) factor heavily into fully diluted share count models, naturally weighing down per-share valuations.
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Kiwi

Thanks Swordman. Will check it out!

Shoutout to the rosebomb and whatalane-- good to see you guys show up for another medical technology that is cutting edge AND saving lives. As some would say--Save millions ( lives ) and Make millions ( $$ )

Scroll back toward 2022 and see how far this technology has come ( the KOL video is good)

This is a stock that I should have gotten in to a while back but didn’t until yesterday morning.  Of course, as management cautions, some of these are early results and we need to let the studies play out, but for now this looks very promising, for so many cancers. What is a bit strange is analysts targets. Average is a tad under 14, with I believe the highest is around 17.  Already some approvals in Israel and Japan. Surprised that there are not some targets higher than that. 

Yep ..results so far look good .
July they have a podium presentation at a cancer conference ...that will be big

Kiwi

I usually shy away from stocks that have gone up a huge percentage recently, but I am in this today. See where it goes. Trial results seem scary good.

Thx for that link .
Impressive data so far

Kiwi

Link for THURS--28 MAY --Lytham Partners conf

https://app.webinar.net/Ew6XKl4KQ71

DART gets talked about in this BioTech video (@ 4:50 mins )

https://www.biotechtv.com/post/biotech-movers-week-of-may-11-2026

Citigroup recently issued a major upgrade for Alpha Tau Medical (NASDAQ: DRTS), raising its price target from $9 to $17 while firmly maintaining its Buy recommendation.

Key Drivers Behind the Upgrade
Citi's dramatic target increase stems from several major milestones and highly anticipated clinical readouts:

Clinical Success Over Brain Cancer:
Alpha Tau recently reported exceptional interim results from its U.S. REGAIN trial for recurrent glioblastoma (GBM), a notoriously hard-to-treat brain cancer. Two out of the first three patients achieved complete responses, with MRI scans showing total tumor disappearance.

Completed Skin Cancer Trials:
The company has finished its cSCC (cutaneous squamous cell carcinoma) Pivotal Trial. The next catalyst will be formal FDA submission for U.S. approval, heavily derisked by previous marketing authorization from Japan's PMDA.

Upcoming ASCO Catalysts:
Analysts expect further upward momentum into the upcoming ASCO (American Society of Clinical Oncology) annual meeting, where the company is slated to share highly anticipated pancreatic cancer survival data.

Combination Therapies:
Additional near-term value drivers include trial results evaluating Alpha DaRT in combination with Merck's blockbuster immunotherapy drug, Keytruda.

Citi emphasized that the market continues to significantly underappreciate the multi-indication potential of Alpha Tau’s specialized radiopharma platform.
Following these developments and Wall Street's validation, the stock has traded near the top of its 52-week range.

Kiwi

Citi Raises Alpha Tau Price Target to $17


Kiwi