Alpha Tau Medical Ltd. is a clinical-stage oncology therapeutics company, which focuses on the research, development, and commercialization of diffusing alpha-emitters radiation therapy for the treatment of cancer. The firm is involved in the clinical trials at cancer centers with indications that include skin cancer, oral cavity cancer, breast cancer, and pancreatic cancer. The company was founded by Uzi Sofer, Yona Keisari, and Itzhak Kelson in November 2015 and is headquartered in Jerusalem, Israel.
相关临床试验
29
6 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
2016
进行中（未招募）
3
10.3%
已完成
6
20.7%
尚未招募
3
10.3%
招募中
15
51.7%
终止
2
6.9%
暂无批准数据
- Stoke Therapeutics surged 11.42% after presenting positive data for zorevunersen in Dravet syndrome at the 2025 AES Annual Meeting with partner Biogen. - Alpha Tau Medical climbed 25.26% following announcement that the first patient was treated in its pilot study for recurrent glioblastoma multiforme using Alpha DaRT technology. - Senti Biosciences gained 3.92% after the FDA granted RMAT designation to SENTI-202, an investigational CAR-NK cell therapy for acute myeloid leukemia and other hematologic malignancies. - Multiple biotech companies showed strong after-hours performance driven by clinical data presentations, regulatory progress, and financing announcements across various therapeutic areas.
- Alpha Tau Medical received FDA approval for an Investigational Device Exemption to initiate a pilot study treating locally recurrent prostate cancer patients with Alpha DaRT technology. - The prostate cancer trial will enroll up to 12 U.S. patients with biochemical recurrence, aiming to evaluate safety and efficacy as an alternative to systemic androgen deprivation therapy. - Two abstracts on Alpha DaRT pancreatic cancer research will be presented at the 2026 ASCO Gastrointestinal Cancers Symposium, demonstrating continued progress in this high unmet need indication. - Alpha Tau's U.S. multi-center pancreatic cancer clinical trial is underway with patient recruitment expected to complete by Q1 2026, targeting up to 30 newly diagnosed patients.
- Bassett Cancer Institute in Cooperstown becomes one of the first U.S. cancer centers to participate in an international clinical trial testing Alpha DaRT radiation therapy for inoperable pancreatic cancer. - The innovative treatment involves implanting radioactive seeds directly into tumors to deliver targeted alpha particle radiation from inside the cancer. - Only 30 patients will be enrolled across participating sites in the United States, Canada, and Israel before the trial closes to new participants. - The study represents a significant advancement in bringing cutting-edge cancer care to rural communities, with Bassett being likely the only rural site participating in this particular trial.
- Oramed Pharmaceuticals is launching a 60-patient U.S. trial for its oral insulin program after identifying high-responder subgroups showing potential for over 1% HbA1c reduction. - The company terminated its joint venture with Hefei Tianhui Biotech and will continue oral insulin development independently to maintain full control. - Oramed's diversified investment portfolio has grown total assets to approximately $210 million by September 2025, up from $155.7 million in January 2023. - The company maintains its commitment to shareholder rewards including plans for a one-time dividend despite continuing the oral insulin program independently.
- Alpha Tau Medical has successfully treated the first patient in its U.S. multi-center IMPACT trial, evaluating Alpha DaRT radiation therapy combined with chemotherapy for unresectable pancreatic adenocarcinoma. - The study targets a critical unmet need, as up to 87% of newly diagnosed pancreatic cancer patients are considered inoperable at diagnosis and face limited treatment options. - Alpha DaRT delivers localized alpha radiation through intratumoral implantation, designed to achieve tumor control in a single session while potentially sparing surrounding healthy tissue. - The pilot study aims to enroll 30 patients across multiple centers and will evaluate safety, feasibility, and efficacy outcomes over six months of follow-up.
- Oramed Pharmaceuticals has invested $36.9 million in Alpha Tau Medical, acquiring approximately 14.1 million shares and establishing a three-year strategic collaboration to accelerate Alpha DaRT cancer therapy development. - The partnership unites two therapeutic delivery innovators—Oramed's oral drug delivery platform with Alpha Tau's precision alpha-radiation technology—with Oramed providing capital markets expertise and appointing two directors to Alpha Tau's board. - Alpha Tau is currently expanding clinical trials across four U.S. indications, developing applications for internal organs, and scaling manufacturing capacity for its breakthrough solid tumor treatment technology.
- Alpha Tau Medical has achieved MDSAP certification for its Jerusalem manufacturing facility, marking a significant milestone in quality and regulatory compliance for its alpha-radiation cancer therapy technology. - The certification, recognized by regulatory authorities in five major markets including the US, Canada, and Japan, streamlines the international audit process for medical device manufacturers. - This achievement is expected to accelerate the global commercialization timeline for Alpha DaRT therapy by enabling efficient compliance with multiple international regulatory standards.
• Alpha Tau Medical's Alpha DaRT therapy has been accepted into the FDA's Total Product Life Cycle Advisory Program for recurrent glioblastoma multiforme (GBM). • A clinical trial has begun in Israel to assess the safety of Alpha DaRT in treating recurrent lung cancer using endobronchial ultrasound. • The FDA has approved a multi-center study for Alpha DaRT to treat recurrent cutaneous squamous cell carcinoma (cSCC) in immunocompromised patients.
- Alpha Tau Medical's Alpha DaRT therapy gains FDA acceptance into the Total Product Life Cycle Advisory Program for recurrent glioblastoma multiforme, aiming to expedite market access. - Clinical trials progress with the first patient treated in a recurrent lung cancer study in Israel, assessing the safety and feasibility of Alpha DaRT delivery via endobronchial ultrasound. - The FDA approves an Investigational Device Exemption for a multi-center study using Alpha DaRT to treat recurrent cutaneous squamous cell carcinoma in immunocompromised patients.
