Alpha Tau Receives FDA Clearance to Expand REGAIN Study
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jun 12 2026
0mins
Source: NASDAQ.COM
- FDA Approval for Expansion: Alpha Tau Medical Ltd. announced FDA clearance to enroll seven additional patients in the REGAIN study and expand U.S. testing sites, aimed at enhancing treatment efficacy for recurrent glioblastomas.
- Promising Efficacy Data: Preliminary results from three patients treated between December 2025 and March 2026 showed a 100% local disease control rate and a 67% complete response rate, indicating the potential of Alpha-DaRT in precision therapy.
- Manageable Safety Profile: Although one grade 3 severe adverse event was reported, it was fully resolved, demonstrating the manageable safety of Alpha-DaRT and providing confidence for further clinical applications.
- Academic Centers Joining: The FDA also authorized the addition of two leading U.S. academic cancer centers to the REGAIN trial, enhancing multidisciplinary neuro-oncology expertise and aiming to broaden access to the therapy while improving research quality.
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About DRTS
Alpha Tau Medical Ltd is an Israel-based medical technology company that focuses on research, development and commercialization of Alpha DaRT Diffusing Alpha-emitters Radiation Therapy (Alpha DaRT) for the treatment of solid cancer. Company's technology relies on the diffusion of atoms that emit alpha particles within the tumor tissue, and enables alpha radiation to reach the the entire tumor. Precise amounts of radioactive radium-224 affixed that emit short-range alpha radiation enables to damages and kills cancer cells within a short period of time. The Company has one subsidiary Healthcare Capital Corp.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
First Glioblastoma Patient Treated with Alpha DaRT in Israel
- Global Milestone: The successful treatment of a 77-year-old male glioblastoma patient at Hadassah University Medical Center marks the first clinical application of Alpha DaRT outside the United States, showcasing the therapy's potential for global expansion.
- Technological Innovation: Utilizing real-time stereotactic neuro-navigation, the treatment precisely delivered Alpha DaRT sources to the recurrent tumor through a minimally invasive approach, ensuring safety and effectiveness, which serves as a crucial reference for similar cases in the future.
- Market Demand: Glioblastoma is the most common and aggressive brain tumor, with approximately 160,000 new cases diagnosed globally each year, and recurrence is virtually inevitable; the application of Alpha DaRT provides a new treatment option for this high-demand market, potentially altering patient survival expectations.
- Clinical Trial Progress: Alpha Tau's ALL clinical protocol is underway, aimed at providing new treatment options for patients ineligible for standard care, and this successful case adds momentum to their multicenter trial in the U.S., further strengthening the clinical foundation for this technology.
See More
Alpha Tau Receives FDA Clearance to Expand REGAIN Study
- FDA Approval for Expansion: Alpha Tau Medical Ltd. announced FDA clearance to enroll seven additional patients in the REGAIN study and expand U.S. testing sites, aimed at enhancing treatment efficacy for recurrent glioblastomas.
- Promising Efficacy Data: Preliminary results from three patients treated between December 2025 and March 2026 showed a 100% local disease control rate and a 67% complete response rate, indicating the potential of Alpha-DaRT in precision therapy.
- Manageable Safety Profile: Although one grade 3 severe adverse event was reported, it was fully resolved, demonstrating the manageable safety of Alpha-DaRT and providing confidence for further clinical applications.
- Academic Centers Joining: The FDA also authorized the addition of two leading U.S. academic cancer centers to the REGAIN trial, enhancing multidisciplinary neuro-oncology expertise and aiming to broaden access to the therapy while improving research quality.
See More
Alpha Tau Resumes Recruitment for GBM Clinical Trial
- Trial Recruitment Resumed: Alpha Tau has received FDA clearance to immediately resume recruitment for the final seven patients in the REGAIN trial, reflecting overwhelming demand from clinicians for rapid treatment, marking the latest regulatory success in addressing recurrent glioblastoma.
- Significant Efficacy Data: As of May 3, 2026, interim results from the first three patients demonstrated a 100% local disease control rate and a 67% complete response rate, indicating that Alpha DaRT® could represent a transformative treatment option for patients with limited alternatives in recurrent glioblastoma.
- Expanded Participating Centers: The FDA has authorized two additional leading U.S. academic cancer centers to join the REGAIN trial, broadening geographic access and clinical expertise, aimed at enhancing patient accessibility and multidisciplinary neuro-oncology support.
- Strategic Importance: The CEO of Alpha Tau emphasized that recurrent glioblastoma is a core strategic indication for the company, and the FDA's approval along with positive clinical data will accelerate the process of making Alpha DaRT a viable treatment option for patients.
See More
Alpha Tau and Tolmar Form Strategic Collaboration for Prostate Cancer Treatment
- Strategic Collaboration Agreement: Alpha Tau Medical and Tolmar International have signed a strategic collaboration agreement to develop and commercialize the Alpha DaRT platform for prostate cancer treatment in the U.S., where prostate cancer is the second leading cause of cancer death among American men, with over 330,000 new cases expected this year, highlighting the urgent need for new treatment options.
- Exclusive Commercialization Rights: Under the agreement, Tolmar will hold exclusive U.S. commercialization rights for prostate cancer indications for 20 years from the first commercial sale, with an option to expand into bladder cancer upon meeting clinical milestones, enhancing both companies' competitive positioning in the market.
- Investment and Milestone Payments: Tolmar has committed an initial $15 million manufacturing investment, a $20 million equity infusion at $11.99 per share, and up to $161.5 million in milestone payments tied to clinical and commercial achievements, providing robust financial support for the development of Alpha DaRT.
- Clinical Development Responsibility: Both parties will share responsibility for clinical development in prostate cancer, with Tolmar funding pivotal trials in the U.S. while Alpha Tau retains rights outside the U.S. for prostate and bladder cancer indications, positioning the collaboration to reshape the U.S. uro-oncology landscape.
See More
ABIVAX and Others See Significant Stock Gains
- ABIVAX Clinical Trial Success: ABIVAX reported positive results from its Phase 3 ABTECT trial for Obefazimod in ulcerative colitis, achieving primary endpoint of clinical remission at Week 44 with both 25mg and 50mg doses, planning to submit a New Drug Application to the FDA in late Q4 2026, leading to a 24.34% stock increase to $90.15.
- Cingulate Faces FDA Challenge: Cingulate's stock rose 21.09% to $4.88 despite the FDA's rejection of its ADHD drug CTx-1301 application; however, with nearly $30 million in cash reserves, the company aims to resolve CMC issues and proceed with resubmission while continuing pre-commercial activities.
- Alpha Tau Partners with Tolmar: Alpha Tau entered a strategic collaboration with Tolmar to develop and commercialize Alpha DaRT for prostate cancer in the U.S., with Tolmar investing $15 million upfront and $20 million equity stake, while Alpha Tau retains manufacturing rights, resulting in an 18.48% stock increase to $10.58.
- MiniMed Strong Financial Results: MiniMed reported worldwide net sales of $3.102 billion for FY 2026, a 14.2% increase, and expects around 10% organic revenue growth for FY 2027, reflecting strong international market performance and new product launches, with stock rising 15.94% to $14.26.
See More
Tolmar Invests $20 Million in Alpha Tau for Prostate Cancer Therapy
- Significant Investment: Tolmar will invest $20 million in Alpha Tau at $11.99 per share, representing a 34% premium over Tuesday's closing price, which not only strengthens Alpha Tau's financial position but also supports its future research and development efforts.
- Substantial Milestone Potential: The deal includes up to $161.5 million in potential development, regulatory, and commercial milestone funding, bringing the total commitment to $196.5 million, reflecting Tolmar's confidence and support for Alpha Tau's future growth.
- Exclusive Commercialization Rights: Tolmar secures exclusive U.S. commercialization rights for Alpha DaRT in prostate cancer, with an option to expand into bladder cancer, providing a strong competitive advantage in the oncology market for Tolmar.
- Optimistic Clinical Trial Results: Recent data from Alpha Tau indicates that its Alpha DaRT therapy shows a median overall survival of 11.2 months in pancreatic cancer patients, with a favorable safety profile and no treatment-related deaths, further boosting investor confidence in its product.
See More
First Glioblastoma Patient Treated with Alpha DaRT in Israel
- Global Milestone: The successful treatment of a 77-year-old male glioblastoma patient at Hadassah University Medical Center marks the first clinical application of Alpha DaRT outside the United States, showcasing the therapy's potential for global expansion.
- Technological Innovation: Utilizing real-time stereotactic neuro-navigation, the treatment precisely delivered Alpha DaRT sources to the recurrent tumor through a minimally invasive approach, ensuring safety and effectiveness, which serves as a crucial reference for similar cases in the future.
- Market Demand: Glioblastoma is the most common and aggressive brain tumor, with approximately 160,000 new cases diagnosed globally each year, and recurrence is virtually inevitable; the application of Alpha DaRT provides a new treatment option for this high-demand market, potentially altering patient survival expectations.
- Clinical Trial Progress: Alpha Tau's ALL clinical protocol is underway, aimed at providing new treatment options for patients ineligible for standard care, and this successful case adds momentum to their multicenter trial in the U.S., further strengthening the clinical foundation for this technology.
See More
Alpha Tau Receives FDA Clearance to Expand REGAIN Study
- FDA Approval for Expansion: Alpha Tau Medical Ltd. announced FDA clearance to enroll seven additional patients in the REGAIN study and expand U.S. testing sites, aimed at enhancing treatment efficacy for recurrent glioblastomas.
- Promising Efficacy Data: Preliminary results from three patients treated between December 2025 and March 2026 showed a 100% local disease control rate and a 67% complete response rate, indicating the potential of Alpha-DaRT in precision therapy.
- Manageable Safety Profile: Although one grade 3 severe adverse event was reported, it was fully resolved, demonstrating the manageable safety of Alpha-DaRT and providing confidence for further clinical applications.
- Academic Centers Joining: The FDA also authorized the addition of two leading U.S. academic cancer centers to the REGAIN trial, enhancing multidisciplinary neuro-oncology expertise and aiming to broaden access to the therapy while improving research quality.
See More
Alpha Tau Resumes Recruitment for GBM Clinical Trial
- Trial Recruitment Resumed: Alpha Tau has received FDA clearance to immediately resume recruitment for the final seven patients in the REGAIN trial, reflecting overwhelming demand from clinicians for rapid treatment, marking the latest regulatory success in addressing recurrent glioblastoma.
- Significant Efficacy Data: As of May 3, 2026, interim results from the first three patients demonstrated a 100% local disease control rate and a 67% complete response rate, indicating that Alpha DaRT® could represent a transformative treatment option for patients with limited alternatives in recurrent glioblastoma.
- Expanded Participating Centers: The FDA has authorized two additional leading U.S. academic cancer centers to join the REGAIN trial, broadening geographic access and clinical expertise, aimed at enhancing patient accessibility and multidisciplinary neuro-oncology support.
- Strategic Importance: The CEO of Alpha Tau emphasized that recurrent glioblastoma is a core strategic indication for the company, and the FDA's approval along with positive clinical data will accelerate the process of making Alpha DaRT a viable treatment option for patients.
See More
Alpha Tau and Tolmar Form Strategic Collaboration for Prostate Cancer Treatment
- Strategic Collaboration Agreement: Alpha Tau Medical and Tolmar International have signed a strategic collaboration agreement to develop and commercialize the Alpha DaRT platform for prostate cancer treatment in the U.S., where prostate cancer is the second leading cause of cancer death among American men, with over 330,000 new cases expected this year, highlighting the urgent need for new treatment options.
- Exclusive Commercialization Rights: Under the agreement, Tolmar will hold exclusive U.S. commercialization rights for prostate cancer indications for 20 years from the first commercial sale, with an option to expand into bladder cancer upon meeting clinical milestones, enhancing both companies' competitive positioning in the market.
- Investment and Milestone Payments: Tolmar has committed an initial $15 million manufacturing investment, a $20 million equity infusion at $11.99 per share, and up to $161.5 million in milestone payments tied to clinical and commercial achievements, providing robust financial support for the development of Alpha DaRT.
- Clinical Development Responsibility: Both parties will share responsibility for clinical development in prostate cancer, with Tolmar funding pivotal trials in the U.S. while Alpha Tau retains rights outside the U.S. for prostate and bladder cancer indications, positioning the collaboration to reshape the U.S. uro-oncology landscape.
See More
ABIVAX and Others See Significant Stock Gains
- ABIVAX Clinical Trial Success: ABIVAX reported positive results from its Phase 3 ABTECT trial for Obefazimod in ulcerative colitis, achieving primary endpoint of clinical remission at Week 44 with both 25mg and 50mg doses, planning to submit a New Drug Application to the FDA in late Q4 2026, leading to a 24.34% stock increase to $90.15.
- Cingulate Faces FDA Challenge: Cingulate's stock rose 21.09% to $4.88 despite the FDA's rejection of its ADHD drug CTx-1301 application; however, with nearly $30 million in cash reserves, the company aims to resolve CMC issues and proceed with resubmission while continuing pre-commercial activities.
- Alpha Tau Partners with Tolmar: Alpha Tau entered a strategic collaboration with Tolmar to develop and commercialize Alpha DaRT for prostate cancer in the U.S., with Tolmar investing $15 million upfront and $20 million equity stake, while Alpha Tau retains manufacturing rights, resulting in an 18.48% stock increase to $10.58.
- MiniMed Strong Financial Results: MiniMed reported worldwide net sales of $3.102 billion for FY 2026, a 14.2% increase, and expects around 10% organic revenue growth for FY 2027, reflecting strong international market performance and new product launches, with stock rising 15.94% to $14.26.
See More
Tolmar Invests $20 Million in Alpha Tau for Prostate Cancer Therapy
- Significant Investment: Tolmar will invest $20 million in Alpha Tau at $11.99 per share, representing a 34% premium over Tuesday's closing price, which not only strengthens Alpha Tau's financial position but also supports its future research and development efforts.
- Substantial Milestone Potential: The deal includes up to $161.5 million in potential development, regulatory, and commercial milestone funding, bringing the total commitment to $196.5 million, reflecting Tolmar's confidence and support for Alpha Tau's future growth.
- Exclusive Commercialization Rights: Tolmar secures exclusive U.S. commercialization rights for Alpha DaRT in prostate cancer, with an option to expand into bladder cancer, providing a strong competitive advantage in the oncology market for Tolmar.
- Optimistic Clinical Trial Results: Recent data from Alpha Tau indicates that its Alpha DaRT therapy shows a median overall survival of 11.2 months in pancreatic cancer patients, with a favorable safety profile and no treatment-related deaths, further boosting investor confidence in its product.
See More
