Welcome to our dedicated page for Alpha Tau Medical news (Ticker: DRTS), a resource for investors and traders seeking the latest updates and insights on Alpha Tau Medical stock.
Alpha Tau Medical Ltd. (NASDAQ: DRTS) is a clinical-stage oncology therapeutics company developing Alpha DaRT, a localized alpha-radiation therapy for solid tumors. The DRTS news feed highlights the company’s clinical progress, regulatory interactions, manufacturing milestones, and financial updates related to this technology.
Recent news has focused on Alpha Tau’s expanding clinical program. The company has reported final results from a first-in-human pancreatic ductal adenocarcinoma study in Montreal, including disease control and response rates, and is running the IMPACT multi-center pilot trial in the United States combining Alpha DaRT with chemotherapy in newly diagnosed unresectable or metastatic pancreatic cancer. News items also cover pilot studies in recurrent glioblastoma multiforme, including the first reported Alpha DaRT treatment in the brain, as well as FDA-approved trials in locally recurrent prostate cancer.
Regulatory and pre-market developments are another frequent theme. Alpha Tau has announced submission of the first module of its pre-market approval application to the U.S. FDA for Alpha DaRT in recurrent cutaneous squamous cell carcinoma, under a modular PMA framework. The company also reports on Breakthrough Device Designations, participation in the FDA’s Total Product Life Cycle Advisory Program, and marketing authorization processes in other regions.
Operational and corporate updates appear regularly, including receipt of a radioactive material license for the company’s manufacturing facility in New Hampshire, participation in major healthcare and investor conferences, and periodic financial results with corporate commentary. Investors and observers can use the DRTS news page to follow key milestones in Alpha Tau’s efforts to advance Alpha DaRT through clinical development, regulatory review, and preparation for potential commercialization.
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.
Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) announced its participation in Citi’s 2023 Healthcare Services, Medtech, Tools & HCIT Conference on March 1, 2023, to be held at Citi HQ Conference Center in New York City.
The Alpha DaRT therapy, developed for treating solid tumors, utilizes radium-224 for targeted alpha-radiation intended to minimize damage to surrounding healthy tissue.
Founded in 2016, Alpha Tau focuses on advancing this innovative approach to cancer treatment, which was created by leading researchers from Tel Aviv University.
Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) announced plans to present its alpha-radiation cancer therapy, Alpha DaRT™, at the upcoming Biotech Showcase in San Francisco, scheduled for January 9-12, 2023. CFO Raphi Levy will discuss the company’s technology, clinical progress, and upcoming trials, including a pivotal trial for recurrent cutaneous squamous cell carcinoma. Additionally, one-on-one institutional investor meetings will be available at both the Biotech Showcase and LifeSci Partners Corporate Access Event on January 10, 2023.
Alpha Tau Medical (Nasdaq: DRTS, DRTSW) reported its Q3 2022 financial results, showing a net loss of $2.6 million ($0.04 per share), significantly improved from a $4.8 million loss in Q3 2021. R&D expenses rose to $4.8 million, driven by increased personnel and study costs. The company remains focused on its upcoming U.S. pivotal study for recurrent cutaneous squamous cell carcinoma and has made significant strides in global commercialization. With a cash balance of $108.5 million, Alpha Tau is well-positioned to sustain operations for at least two years.
Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) announced its participation in two investor conferences this November. The first event is the Jefferies London Healthcare Conference on November 16, 2022, at 4:25 PM GMT in London. The second is the Piper Sandler 34th Annual Healthcare Conference on November 30, 2022, at 1:30 PM EST in New York. The company focuses on the innovative alpha-radiation cancer therapy, Alpha DaRT, aimed at effectively targeting solid tumors while minimizing damage to surrounding healthy tissue.
Alpha Tau Medical Ltd. (NASDAQ: DRTS, DRTSW) announced significant advancements in its clinical research and trials. The Medicines and Healthcare products Regulatory Agency of the UK approved a trial for treating squamous cell carcinoma of the vulva, while Health Canada added a second site at Jewish General Hospital in Montreal for pancreatic cancer trials. Additionally, findings from a U.S. pilot study on the Alpha DaRT treatment will be presented at the upcoming ASTRO 2022 Annual Meeting. These developments illustrate Alpha Tau's commitment to expanding its innovative cancer therapies.