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Alpha Tau Medical (DRTS)

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Research analysts covering Alpha Tau Medical.

Recent press releases and 8-K filings for DRTS.

Alpha Tau Medical Ltd Discusses Recent Developments and Commercialization Outlook
DRTS
New Projects/Investments
Guidance Update
Product Launch
  • Alpha Tau Medical Ltd (DRTS) announced the treatment of its first patient in recurrent glioblastoma (GBM) at Ohio State University yesterday.
  • The pivotal study for recurring skin cancer in the U.S. is expected to complete patient recruitment in Q1 2026, with data anticipated in the second half of 2026 for FDA submission.
  • As of Q3, Alpha Tau Medical reported $76 million in cash and deposits and a quarterly burn rate of approximately $5 million, indicating the company is well-financed for upcoming quarters.
  • The earliest target for a significant commercial launch in the U.S. is estimated to be around end of 2026 or beginning of 2027.
Dec 10, 2025, 4:30 PM
Alpha Tau Medical Provides Updates on Clinical Trials and Commercialization Timeline
DRTS
New Projects/Investments
Guidance Update
Revenue Acceleration/Inflection
  • Alpha Tau Medical (DRTS) is advancing its Alpha DaRT technology, which delivers localized alpha particle radiation directly into tumors, showing broad applicability across solid tumor types.
  • The company anticipates completing patient recruitment for its pivotal U.S. study in recurrent skin cancer by Q1 2026, with data expected in Q3 2026 for FDA submission, targeting a U.S. commercial launch by end of 2026 or early 2027.
  • Recent milestones include treating the first patient in recurrent glioblastoma on December 9, 2025, and completing recruitment for a pilot study in pancreatic cancer by Q1 2026.
  • A study combining Alpha DaRT with Keytruda in metastatic head and neck cancer demonstrated a 100% objective response rate in six evaluable patients, suggesting potential for systemic anti-tumor immunity.
  • Alpha Tau Medical reported $76 million in cash and deposits at Q3 2025, with a quarterly burn rate of approximately $5 million, providing sufficient financing for upcoming quarters.
Dec 10, 2025, 4:30 PM
DRTS Updates on Clinical Milestones and Financial Position
DRTS
New Projects/Investments
Guidance Update
Product Launch
  • DRTS announced the treatment of its first patient in recurrent glioblastoma (brain cancer) at Ohio State University, achieving over 95% tumor coverage.
  • The company anticipates completing patient recruitment for its pivotal U.S. study in recurrent skin cancer by Q1 2026 and its pilot U.S. study in pancreatic cancer by the end of Q1 2026, with data expected later in the year for both.
  • DRTS reported $76 million in cash and deposits at Q3, with a quarterly burn rate of approximately $5 million, indicating a strong financial position for the coming quarters.
  • Early data from a study combining Alpha DaRT with Keytruda in metastatic head and neck cancer showed a 100% objective response rate (3 complete responses, 3 partial responses) in six patients, significantly higher than Keytruda alone.
  • The earliest projected timeline for a major commercial launch in the U.S. is end of 2026 or beginning of 2027, initially for skin cancer, with potential for later launches in other indications like pancreas or brain.
Dec 10, 2025, 4:30 PM
Alpha Tau Medical Treats First Patient in U.S. Glioblastoma Trial
DRTS
New Projects/Investments
  • Alpha Tau Medical Ltd. announced on December 9, 2025, the successful treatment of the first patient in its U.S. trial for recurrent glioblastoma at The Ohio State University.
  • This event represents the first time in the world that a brain cancer patient has been treated with the company's innovative Alpha DaRT® technology.
  • The pilot study is designed to enroll up to ten U.S. patients with recurrent glioblastoma and will evaluate the feasibility and safety of the Alpha DaRT treatment.
  • Alpha DaRT has received FDA Breakthrough Device Designation and acceptance into the FDA's Total Product Life Cycle Advisory Program, aiming to accelerate its market entry for patients with high unmet needs like those with glioblastoma.
Dec 9, 2025, 2:02 PM
Alpha Tau Medical Treats First Patient in U.S. Glioblastoma Trial
DRTS
New Projects/Investments
  • Alpha Tau Medical (Nasdaq: DRTS) announced on December 9, 2025, that the first patient has been treated in its pilot study for recurrent glioblastoma multiforme (GBM) using the Alpha DaRT® technology.
  • This marks the first time Alpha DaRT has been used to treat brain cancer, addressing a critical unmet need for GBM patients who face a devastating prognosis.
  • The treatment was administered at The Ohio State University Center in Columbus, Ohio, by a multidisciplinary team.
  • The pilot study is designed to enroll up to ten U.S. patients with recurrent glioblastoma not amenable to surgical resection, with the primary objective of evaluating the feasibility and safety of the treatment.
  • The Alpha DaRT technology has received FDA's Breakthrough Device Designation and acceptance into the Total Product Life Cycle Advisory Program, aimed at accelerating its market entry.
Dec 9, 2025, 2:00 PM
Alpha Tau Medical Ltd. Receives FDA Approval for Prostate Cancer Trial
DRTS
Product Launch
New Projects/Investments
  • Alpha Tau Medical Ltd. (DRTS) announced on December 2, 2025, that it received FDA approval for an Investigational Device Exemption (IDE) application.
  • This approval enables the company to initiate a pilot study in the U.S. for treating patients with locally recurrent prostate cancer using its Alpha DaRT technology.
  • This marks Alpha Tau's fifth simultaneous active U.S. IDE, expanding the reach of Alpha DaRT into recurrent prostate cancer.
  • The clinical trial is expected to enroll up to 12 U.S. patients to evaluate the safety and efficacy of the Alpha DaRT treatment for this indication.
Dec 2, 2025, 2:02 PM
Alpha Tau Medical Ltd. Announces Third Quarter 2025 Financial Results and Corporate Update
DRTS
Earnings
Guidance Update
New Projects/Investments
  • Alpha Tau Medical Ltd. announced its third quarter 2025 financial results and provided a corporate update.
  • For the nine months ended September 30, 2025, the company reported a net loss of $30.5 million, or $0.39 per share, with Research and Development expenses reaching $22.5 million.
  • As of September 30, 2025, Alpha Tau's cash, cash equivalents & deposits balance stood at $75.9 million.
  • The company received a radioactive material license for its New Hampshire manufacturing facility in October, with plans to initiate Alpha DaRT treatment manufacturing onsite in 2026.
  • Key upcoming milestones include the completion of patient recruitment in the U.S. pivotal ReSTART trial in Q1 2026 and an expected response from Japan's PMDA regarding marketing authorization around year-end 2025.
Nov 20, 2025, 9:07 PM
Alpha Tau Medical Provides Updates on Clinical Trials, Manufacturing, and Financial Position
DRTS
New Projects/Investments
Guidance Update
Product Launch
  • Alpha Tau Medical (DRTS) is advancing its alpha radiation technology, Alpha DaRT, for cancer treatment, with a pivotal U.S. trial for recurrent cutaneous SCC expected to complete recruitment later this year (2025) and data by mid-2026.
  • The company initiated a U.S. pilot study for 30 newly diagnosed pancreatic cancer patients in Q3 2025, with recruitment expected to finish early 2026 and data by 2H 2026.
  • Early data from a study combining Alpha DaRT with Keytruda for metastatic head and neck cancer showed significantly improved response rates, with 75% objective response and 37.5% complete response in 8 patients.
  • Alpha Tau is expanding its manufacturing capabilities with a new commercial-scale facility in Hudson, New Hampshire, projected to have a capacity of up to 15,000 patients per year and be operational early 2026.
  • The company reported $83 million in cash and deposits as of its Q2 balance sheet and a consistent burn rate of approximately $5 million per quarter, indicating it is well-financed for the near term.
Sep 30, 2025, 4:30 PM
Alpha Tau Medical Announces Q1 2025 Results
DRTS
Earnings
New Projects/Investments
  • Alpha Tau Medical Ltd. reported its Q1 2025 results, including a net loss of $8.7 million and increased R&D and G&A expenses, reflecting ongoing investments in clinical development.
  • Interim clinical trial data showed over 90% disease control in pancreatic cancer and a 75% systemic objective response rate in head and neck cancer trials, marking significant progress in their Alpha DaRT program.
  • The company received FDA approval for key IDE studies in pancreatic cancer and recurrent glioblastoma, setting the stage for vital U.S. pilot studies.
  • Alpha Tau bolstered its capital position by completing a $36.9 million financing in April 2025 and achieving MDSAP certification for its Jerusalem facility.
May 19, 2025, 12:00 AM
Alpha Tau Medical Closes $36.9M Offering and Forms Strategic Alliance
DRTS
New Projects/Investments
  • Alpha Tau Medical Ltd. closed a registered direct offering, selling 14,110,121 ordinary shares at $2.612 per share and raising gross proceeds of approximately $36.9 million.
  • The deal includes a strategic marketing alliance with Oramed Pharmaceuticals, with the investor set to provide IR/PR services and receive the right to nominate two directors within three months.
  • Net proceeds will be used for general corporate purposes including research and development, manufacturing expansion, and the potential commercialization of product candidates.
Apr 28, 2025, 12:00 AM