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 (NASDAQ: DRTS), developer of the Alpha DaRT® alpha-radiation cancer therapy, has announced its participation in the upcoming Ladenburg Oncology Innovators & Investors Symposium.
CFO Raphi Levy will represent the company at this virtual event, scheduled for December 12, 2024, from 11:00 AM to 11:25 AM EST. The format will include both a presentation and one-on-one meetings, which can be arranged through Ladenburg representatives.
Alpha Tau Medical (NASDAQ: DRTS) reported Q3 2024 financial results and corporate updates. Key developments include acceptance into FDA's Total Product Life Cycle Advisory Program (TAP) for Alpha DaRT® treatment of recurrent glioblastoma, first patient treatment in a recurrent lung cancer study in Israel, and FDA approval for a multi-center study treating recurrent cutaneous squamous cell carcinoma. The company reported a net loss of $22.3 million ($0.32 per share) for the nine months ended September 30, 2024. Cash position stands at $68.4 million, providing runway for at least two years.
Alpha Tau Medical (NASDAQ: DRTS), developer of the Alpha DaRT® alpha-radiation cancer therapy, announces CFO Raphi Levy's participation in two major healthcare conferences. Levy will attend the Citi 2024 Global Healthcare Conference on December 3rd in Miami, FL, participating in one-on-one meetings from 8:30 AM to 4:30 PM EST. Additionally, he will join the Piper Sandler 36th Annual Healthcare Conference on December 5th in New York, NY, featuring a fireside chat from 10:00-10:25 AM EST along with one-on-one meetings.
Alpha Tau Medical (NASDAQ: DRTS, DRTSW) has been accepted into the FDA's Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot to accelerate market access for Alpha DaRT® in treating recurrent glioblastoma multiforme (GBM). This follows the company's previous Breakthrough Device Designation for this indication. TAP aims to expedite patient access to innovative medical devices by providing early, frequent, and strategic communications with the FDA and facilitating engagement with key stakeholders.
The program offers tailored assistance from FDA TAP advisors to advance devices to market, focusing on product lifecycle regulation, payer coverage policies, and integration of patient insights. With an estimated 14,000 new GBM diagnoses per year in the U.S. and low five-year survival rates, Alpha Tau sees this as a important step in their strategy to treat internal organs with high unmet medical needs.
Alpha Tau Medical (NASDAQ: DRTS, DRTSW) has treated its first patient with recurrent lung cancer using the Alpha DaRT® therapy at Hadassah Medical Center in Jerusalem, Israel. The clinical trial aims to treat up to ten patients with recurrent tumors in the mediastinum area, allowing concurrent use of other therapies if indicated. The study will assess the safety and feasibility of delivering Alpha DaRT sources into the lung using an endobronchial ultrasound (EBUS) procedure, as well as evaluate the efficacy of Alpha DaRT for this indication.
Lung cancer is the leading cause of cancer-related deaths worldwide, with almost 2.5 million new cases detected annually. In the U.S., it's the third most common cancer, with an estimated 210,000 new cases per year. The Alpha DaRT treatment offers a potential new approach for patients with treatment options, especially those who have already undergone conventional radiation therapy.
Alpha Tau Medical (NASDAQ: DRTS, DRTSW) announced FDA approval of an Investigational Device Exemption (IDE) for a multi-center study using Alpha DaRT® to treat recurrent cutaneous Squamous Cell Carcinoma (cSCC) in immunocompromised patients. The study, led by Winship Cancer Institute of Emory University, will enroll up to 28 U.S. patients across 8 institutions.
The trial's primary efficacy objective is the objective response rate (ORR), with secondary objectives including progression-free survival, overall survival, and local control. Immunocompromised patients face a significantly higher risk of cSCC, with organ transplant recipients having a 65-100 fold greater incidence compared to the general population.
This study addresses clinician requests to treat immunocompromised patients, who are ineligible for Alpha Tau's ongoing ReSTART pivotal trial for recurrent cSCC. The company aims to provide a new potential treatment alternative for this vulnerable population.
Alpha Tau Medical (NASDAQ: DRTS, DRTSW), developer of the Alpha DaRT® alpha-radiation cancer therapy, has announced its participation in four upcoming investor conferences. CFO Raphi Levy will present at the following events:
1. H.C. Wainwright 26th Annual Global Investment Conference on September 10, 2024, in New York, NY
2. Sidoti Small-Cap Virtual Investor Conference on September 19, 2024 (virtual)
3. Redburn Atlantic and Rothschild & Co 2024 Radiopharma Conference on September 26, 2024, in New York, NY
4. Lytham Partners Fall 2024 Investor Conference on October 1, 2024 (virtual)
Mr. Levy will be available for one-on-one investor meetings at all conferences. Interested parties should contact their respective conference representatives to schedule meetings.
Alpha Tau Medical (NASDAQ: DRTS), developer of the Alpha DaRT® cancer therapy, reported Q2 2024 financial results and provided a corporate update. Key highlights include:
- First patient treated for liver metastases from colorectal cancer in May
- Publication in Cancers journal showing nearly 100% overall response rate in treated lesions
- Cash balance of $74.1 million, providing at least two years of runway
- ReSTART U.S. pivotal trial in recurrent cutaneous squamous cell carcinoma progressing
- Ongoing internal organ trials generating strong clinician interest
- New manufacturing plant in Hudson, NH approved and under renovation
Financial results for H1 2024 show R&D expenses of $13.3 million, marketing expenses of $1.1 million, and G&A expenses of $3.0 million. Net loss was $15.4 million ($0.22 per share), compared to $16.9 million ($0.24 per share) in H1 2023.
Alpha Tau announced the publication of long-term safety and efficacy data for its Alpha DaRT™ cancer therapy in the journal Cancers. The pooled analysis included 81 patients with hard-to-treat skin, head and neck, and oral cavity cancers from four international clinical trials. The results demonstrated an overall response rate of 99%, with a complete response rate of 89% and a 10% partial response rate. No moderate or severe long-term toxicities were observed, and the two-year local recurrence-free survival was estimated at 77%. Follow-up spanned up to 51 months, with a median of 14 months. The study suggests that Alpha DaRT may offer long-term disease control with minimal side effects for difficult-to-treat cancers.
Alpha Tau Medical, a leader in alpha-radiation cancer therapy, announced its participation in the Jefferies Global Healthcare Conference on June 5, 2024. Their CFO, Raphi Levy, will present a corporate overview and update at the event scheduled from 1:30 to 1:55 PM EST in New York. Levy will also be available for one-on-one meetings with investors during the conference. Attendees are encouraged to contact their Jefferies representative to schedule a session.