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) received Shonin (MHLW) marketing approval in Japan for Alpha DaRT to treat unresectable locally advanced or locally recurrent head and neck cancer on Feb 24, 2026.
The approval is the platform's first regulatory clearance outside Israel and requires a post-market surveillance study enrolling 66 patients across five Japanese centers. The company plans discussions on reimbursement and further clinical evaluation with Japanese regulators and clinicians.
Alpha Tau (Nasdaq: DRTS) outlined a busy 2026 with five concurrent U.S. clinical trials, targeted patient‑accrual milestones and planned data readouts across pancreatic cancer, GBM and recurrent cutaneous SCC.
The company reported FDA Modular PMA submissions, a radioactive license for its Hudson, NH manufacturing phase, ongoing manufacturing scale‑up, and extensive IP activity (60+ filings, ~50 grants).
Alpha Tau (Nasdaq: DRTS) reported final results from its first-in-human pancreatic ductal adenocarcinoma (PDAC) study in Montreal, with data presented at ASCO GI 2026 (Jan 8–10, 2026).
Key clinical readouts: 22% objective response rate (ORR) and 81% disease control rate (DCR) across 32 patients (or 23% ORR and 87% DCR excluding the first two low‑dose patients). Immune marker analysis in 23 patients showed no significant worsening of NLR, PLR, CD4/CD8 ratio, or CRP one month post‑treatment, plus a dramatic drop in IL‑6 (p<0.000001), suggesting immune preservation and a potential anti‑inflammatory effect. The company is continuing U.S. multi‑center combination testing in the IMPACT trial (NCT06698458).
Alpha Tau (NASDAQ: DRTS) submitted the first module of a PMA application to the FDA on Jan 5, 2026, using a modular submission approach allowed by the FDA to enable ongoing review and feedback.
The submitted module focuses on non-clinical study documentation for Alpha DaRT® to treat recurrent cutaneous squamous cell carcinoma (cSCC) in patients not eligible for surgery or standard radiation.
Alpha Tau is running the multi-center pivotal ReSTART study, expects to complete patient recruitment in Q1 2026, and holds Breakthrough Device Designation for recurrent cSCC, recurrent GBM, and recurrent oral cavity SCC.
Alpha Tau (NASDAQ: DRTS) will present a corporate overview and update at the J.P. Morgan 2026 Healthcare Conference on January 15, 2026 at 11:15am PT / 2:15pm ET in San Francisco.
CEO Uzi Sofer and CFO Raphi Levy will review recent achievements and the outlook for upcoming data milestones, and will host institutional 1-on-1 investor meetings. The presentation runs 11:15am–11:55am PT at Westin St. Francis. A webcast link will be posted on the company’s Events & Presentations page.
Alpha Tau (Nasdaq: DRTS) announced on December 9, 2025 that it treated the first patient in a U.S. pilot study of Alpha DaRT for recurrent glioblastoma multiforme (GBM) at The Ohio State University James Cancer Hospital.
The procedure used a novel intracranial delivery device integrated with standard brain navigation and reportedly achieved >95% tumor-volume coverage. The company noted FDA Breakthrough Device Designation and acceptance into the FDA Total Product Life Cycle Advisory Program to accelerate development for GBM patients.
Alpha Tau (NASDAQ: DRTS) announced two abstracts from its pancreatic cancer pilot studies were accepted for presentation at the 2026 ASCO Gastrointestinal Cancers Symposium (Jan 8-10, 2026) in San Francisco.
The abstracts report feasibility, safety and efficacy of endoscopic ultrasound-guided Alpha DaRT and inflammatory/immune marker dynamics after intratumoral Alpha DaRT from a recently completed Montreal pilot trial. Alpha Tau treated its first U.S. multi-center pancreatic cancer patient in September 2025; the U.S. trial plans to enroll up to 30 patients with recruitment expected to finish by the end of Q1 2026. The company emphasized the program targets a population where up to 87% of newly diagnosed patients are considered inoperable.
Alpha Tau (NASDAQ: DRTS) announced that the FDA approved an Investigational Device Exemption (IDE) to start a pilot study of Alpha DaRT for patients with locally recurrent prostate cancer on Dec 2, 2025. The IDE is Alpha Tau’s fifth active U.S. IDE and the U.S. trial will enroll up to 12 patients meeting biochemical recurrence by the Phoenix definition (PSA rise ≥2 ng/mL from nadir).
The study’s primary objective is to evaluate safety; secondary objectives include biochemical and clinical progression and overall survival. Management positions Alpha DaRT as a focused local salvage alpha-radiation option to potentially replace systemic androgen deprivation therapy for recurrent prostate cancer.
Alpha Tau (NASDAQ: DRTS, DRTSW) announced that CFO Raphi Levy will present at two investor conferences in December 2025: a Fireside Chat at the 37th Annual Piper Sandler Healthcare Conference on Dec 3, 2025, 1:00–1:25 PM ET in New York, and a Company Presentation at Sidoti's Year End Virtual Investor Conference on Dec 10, 2025, 11:30 AM–12:00 PM ET.
Mr. Levy will be available for 1x1 investor meetings at both events; investors should contact their Piper Sandler or Sidoti representatives to schedule.
Alpha Tau (NASDAQ: DRTS) reported a corporate update and third-quarter 2025 results highlighting clinical progress, a new U.S. radioactive material license, and strengthened cash resources. The company began U.S. pancreatic cancer treatments, expects a first U.S. GBM patient in Q4 2025, and targets completion of ReSTART and pancreatic trial recruitment by Q1 2026. The New Hampshire facility license enables onsite Alpha DaRT manufacturing with initial nameplate capacity of ~400,000 sources.
Financials: cash and short-term deposits of $75.9M and a nine-month net loss of $30.5M versus $22.3M a year earlier; R&D spend rose to $22.5M.