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.
Oramed Pharmaceuticals has announced a $36.9 million strategic investment in Alpha Tau Medical (Nasdaq: DRTS), acquiring approximately 14.1 million ordinary shares at $2.612 per share through a registered direct offering.
The partnership includes a three-year service agreement where Oramed will provide Alpha Tau with investor outreach, strategic guidance, and capital markets expertise. The collaboration unites two therapeutic delivery pioneers, combining Oramed's oral drug delivery platform with Alpha Tau's Alpha DaRT® alpha-radiation cancer therapy technology.
As part of the deal, Oramed will appoint two directors to Alpha Tau's Board. The investment aims to support Alpha Tau's ongoing developments, including:
- US clinical trials across four indications
- Manufacturing scale-up initiatives
- Commercialization efforts
- Expansion into trials for multiple internal organs
Alpha Tau Medical (NASDAQ: DRTS) has received FDA approval for an Investigational Device Exemption (IDE) to begin a pilot study treating recurrent glioblastoma (GBM) patients with their Alpha DaRT® technology. The trial will enroll up to 10 U.S. patients with recurrent GBM who are not candidates for surgery and have previously undergone central nervous system radiation.
The study's primary goal is to assess the feasibility and safety of the treatment, building on promising pre-clinical results. This approval follows the FDA's earlier Breakthrough Device Designation and acceptance into the FDA's Total Product Life Cycle Advisory Program, aimed at accelerating the Alpha DaRT treatment's path to market.
Glioblastoma is described as one of the most complex and treatment-resistant cancers, with an average survival rate of only 8 months, according to the National Brain Tumor Society.
Alpha Tau Medical (NASDAQ: DRTS) reported its full year 2024 financial results and corporate updates. The company's innovative Alpha DaRT cancer therapy showed promising interim results across multiple trials:
Key clinical highlights include high disease control rates in pancreatic cancer trials, and impressive response rates in combination with Keytruda for head and neck cancer treatment. The company received FDA approval for a U.S. pilot study combining Alpha DaRT with first-line chemotherapy for pancreatic cancer patients.
Financial results show:
- R&D expenses: $27.0M (vs $26.4M in 2023)
- Net loss: $31.8M or $0.45 per share (vs $29.2M in 2023)
- Cash position: $62.9M (vs $84.9M in 2023)
Alpha Tau Medical (NASDAQ: DRTS), developer of the Alpha DaRT® alpha-radiation cancer therapy, has announced its participation in upcoming investor conferences for March 2025. The company's CFO, Raphi Levy, will be presenting and available for one-on-one investor meetings.
Investors interested in scheduling meetings with Mr. Levy can coordinate through their representatives at Investor Summit Group, Oppenheimer, and Sidoti. The conferences represent an opportunity for investors to learn more about Alpha Tau's innovative cancer treatment technology and business developments.
Alpha Tau Medical (NASDAQ: DRTS) has achieved Medical Device Single Audit Program (MDSAP) certification for its Jerusalem manufacturing facility. This certification, established by regulatory authorities from Australia, Brazil, Canada, Japan, and the U.S., enables medical device manufacturers to undergo a single audit for ISO 13485 compliance and standards across these five markets.
The MDSAP certification may accelerate the commercialization timeline in participating countries through a streamlined auditing process. This achievement reflects Alpha Tau's commitment to quality, safety, and regulatory compliance while supporting the global expansion of their Alpha DaRT® alpha-radiation cancer therapy for solid tumors.
Alpha Tau Medical (NASDAQ: DRTS) has received FDA approval for an IDE supplement to expand its pilot trial of Alpha DaRT® cancer therapy. The expanded study will now include 30 total patients across two cohorts: patients with locally advanced pancreatic cancer and those with metastatic pancreatic cancer. This represents an increase from the previously announced 12-patient study examining Alpha DaRT combined with first-line chemotherapy in newly diagnosed metastatic pancreatic cancer patients.
The expanded trial will be conducted across up to 10 U.S. clinical trial sites, with each cohort consisting of 15 patients. This expansion follows recently released data showing positive results in disease control and overall survival for pancreatic cancer patients treated with Alpha DaRT.
Alpha Tau Medical (NASDAQ: DRTS) announced positive interim data from multiple clinical trials of its Alpha DaRT® cancer therapy. Key highlights include:
In pancreatic cancer trials across Canada and Israel (41 patients), the treatment showed a 100% delivery success rate, 18% objective response rate, and 91% disease control rate. Ad-hoc analyses suggested improved median overall survival compared to historical studies.
In head and neck cancer trials combining Alpha DaRT with pembrolizumab (8 patients), results showed a 75% systemic objective response rate and 37.5% systemic complete response rate, significantly higher than historical benchmarks.
The company received FDA approval for a U.S. pilot study combining Alpha DaRT with first-line chemotherapy in metastatic pancreatic cancer patients, and French approval for a multicenter trial with capecitabine in locally advanced pancreatic cancer.
Additional case studies demonstrated promising results in treating liver metastases, lung cancer, and rectal cancer patients.
Alpha Tau Medical (NASDAQ: DRTS), developer of the Alpha DaRT® cancer therapy, announced two significant upcoming events. First, an abstract on pancreatic adenocarcinoma trials will be presented at the 2025 ASCO Gastrointestinal Cancers Symposium (January 23-25, 2025) in San Francisco. The presentation will occur during Poster Session B on January 24.
Additionally, the company will host an R&D Update Day on January 27, 2025, where they will discuss new data from both Israeli and Canadian pancreatic cancer trials, including feasibility, safety, tumor response, and survival metrics. The update will also cover findings from trials combining Alpha DaRT with pembrolizumab for head and neck cancer treatment.
Alpha Tau Medical (Nasdaq: DRTS) announced changes to its Board of Directors, with Maya Netser joining and Meir Jakobsohn stepping down but continuing as an advisor. Netser brings over 25 years of experience as a C-level technology leader, board member, and investor. She is the founder of Quantum Leap VC and previously served as CEO of Cabaret Biotech, where she led the company to a successful acquisition by Kite Pharma and Gilead Sciences.
Netser's appointment comes at a strategic time as Alpha Tau expands into internal organ treatments with its Alpha DaRT® cancer therapy. She holds an LL.B and MBA from Tel Aviv University and is a member of the Israeli National Team of Directors.
Alpha Tau Medical (NASDAQ: DRTS), developer of the Alpha DaRT® alpha-radiation cancer therapy, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. CEO Uzi Sofer and CFO Raphi Levy will deliver a corporate overview and update on January 16, 2025, from 9:45 AM to 10:25 AM PT at the Westin St. Francis in San Francisco. The presentation will highlight recent company achievements and upcoming data milestones. Institutional investors can schedule one-on-one meetings with the executives through their J.P. Morgan representatives. A webcast of the presentation will be available on the company's website in the Investor Relations section.