Welcome to our dedicated page for Alpha Tau Medical news (Ticker: DRTSW), a resource for investors and traders seeking the latest updates and insights on Alpha Tau Medical stock.
Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) is an Israeli clinical-stage oncology therapeutics company developing Alpha DaRT®, a radium-224–based intratumoral alpha-radiation therapy for solid tumors. The news flow around Alpha Tau centers on clinical trial progress, regulatory interactions, and operational milestones related to this technology.
Company press releases describe ongoing and planned studies of Alpha DaRT in several high-need cancer indications, including recurrent cutaneous squamous cell carcinoma, pancreatic ductal adenocarcinoma, recurrent glioblastoma multiforme, recurrent squamous cell carcinoma of the oral cavity, and locally recurrent prostate cancer. News items highlight first-in-human treatments, such as the first patient treated in a U.S. multi-center pancreatic cancer trial and the first patient treated with Alpha DaRT in the brain for recurrent glioblastoma.
Regulatory and development updates are another recurring theme. Alpha Tau reports Breakthrough Device Designation from the U.S. Food and Drug Administration for multiple indications, participation in the FDA’s Total Product Life Cycle Advisory Program for recurrent GBM, and submission of the first module of a pre-market approval application for Alpha DaRT in recurrent cutaneous squamous cell carcinoma using a modular framework. The company also discloses FDA approval of an Investigational Device Exemption for a pilot study in locally recurrent prostate cancer.
Operational and corporate news includes securing a radioactive material license for a commercial-scale Alpha DaRT manufacturing facility in New Hampshire, interim financial results, and participation in healthcare and investor conferences hosted by organizations such as J.P. Morgan, Piper Sandler, Sidoti, and Jefferies. Investors and observers following DRTS and DRTSW can use this news page to review Alpha Tau’s reported clinical milestones, regulatory steps, manufacturing preparation, and capital markets activities as they relate to the Alpha DaRT platform.
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Alpha Tau Medical Ltd. has initiated a feasibility and safety study of its Alpha DaRT cancer therapy, treating the first patient with advanced inoperable pancreatic cancer. Conducted at Jewish General Hospital in Montreal, the study aims to recruit 30 participants with Stage II to IV pancreatic cancer. It will assess the procedure's safety and feasibility, targeting the overall response and survival rates. CEO Uzi Sofer highlighted the trial as a significant milestone in expanding Alpha DaRT's applications. The technology uses alpha radiation for targeted tumor treatment while minimizing damage to surrounding healthy tissues.
Alpha Tau Medical Ltd. (NASDAQ: DRTS, DRTSW) announced its CFO, Raphi Levy, will present at the Jefferies Radiopharma Innovation Summit on April 3, 2023, from 3:30-4:00 PM ET in New York City. This summit focuses on innovations in the radiopharmaceutical sector. Levy will also conduct one-on-one investor meetings during the event. Founded in 2016, Alpha Tau specializes in the development of the Alpha DaRT™, a novel alpha-radiation therapy aimed at treating solid tumors. The technology was initially developed by experts from Tel Aviv University.
Alpha Tau Medical Ltd. (NASDAQ: DRTS, DRTSW) reassured investors regarding Silicon Valley Bank's recent closure, stating no financial ties existed that would impact operations. The company develops Alpha DaRT™, a therapy aimed at treating solid tumors with targeted alpha radiation, designed to minimize damage to surrounding healthy tissue. Founded in 2016, Alpha Tau focuses on furthering its technology's commercialization. The release includes forward-looking statements, cautioning that actual results may differ due to various factors including the need for regulatory approval and potential funding challenges.
Alpha Tau Medical Ltd. (NASDAQ: DRTS, DRTSW) reported its 2022 financial results, achieving significant milestones in cancer treatment development. The company initiated its pivotal U.S. trial for recurrent cutaneous squamous cell carcinoma (ReSTART) and received Health Canada approval for a liver cancer feasibility trial. Financially, it recorded a net loss of $33.8 million, or $0.53 per share, compared to $27.3 million, or $0.67 per share in 2021. The cash balance stands at $105.4 million, securing operational runway for at least two years. Future focuses include expanding clinical trials and increasing production capacity.
Alpha Tau Medical Ltd. (NASDAQ: DRTS, DRTSW) has announced the enrollment of its first two patients in the pivotal multicenter ReSTART trial, focusing on the treatment of recurrent cutaneous squamous cell carcinoma (cSCC) with its Alpha DaRT™ therapy. The trial aims to enroll up to 86 patients across the U.S., Canada, Europe, and Israel to evaluate efficacy and safety. Key endpoints include overall response rates and durability of response. CEO Uzi Sofer emphasized the milestone's significance for regulatory approval and recruitment efforts. The Alpha DaRT technology is designed for localized tumor treatment while preserving healthy tissue.
Alpha Tau Medical Ltd. (NASDAQ: DRTS, DRTSW) has received an amended radioactive license from the Israeli Ministry of Environmental Protection, increasing its Thorium-228 limit from 30 milliCurie to 100 milliCurie. This change allows the Jerusalem facility to potentially produce up to 300,000 Alpha DaRT sources annually. Additionally, approvals for a pre-clinical radioactive lab have been obtained, enabling the company to conduct experiments with mice and rats. CEO Uzi Sofer emphasized the importance of expanding manufacturing capacity to meet growing clinical trial demands and to explore combination therapies in-house.
Alpha Tau Medical Ltd. (NASDAQ: DRTS, DRTSW) has received authorization from Health Canada for a feasibility and safety study of its innovative alpha-radiation therapy, Alpha DaRT, in treating liver metastases. This study, set to be conducted at the McGill University Health Center, aims to recruit 10 patients undergoing a two-stage hepatectomy for colorectal cancer. The trial will assess the feasibility of delivering Alpha DaRT sources and monitor safety through adverse events. CEO Uzi Sofer emphasized this milestone expands Alpha DaRT's potential applications in treating hard-to-treat cancers, marking a significant step forward for the company.