Alpha Tau Medical Ltd Stock Price, News & Analysis

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.

Alpha Tau (NASDAQ: DRTS) said CFO Raphi Levy will participate at the Jefferies Global Healthcare Conference in London on November 18–19, 2025.

Mr. Levy will take part in 1x1 investor meetings; investors should contact their Jefferies representative to schedule meetings.

Alpha Tau (Nasdaq: DRTS) received a radioactive material license from the State of New Hampshire Radiological Health Section for the first phase of its commercial-scale manufacturing facility in Hudson, New Hampshire.

The standalone building exceeds 14,000 rentable square feet and the first-phase nameplate capacity is approximately 400,000 Alpha DaRT sources for local use. The license allows the company to introduce thorium generators, equip the plant, and proceed with verification and validation steps aimed at producing Alpha DaRT treatments during 2026. Alpha DaRT is under evaluation in multiple clinical trials across several tumor types, including skin, head & neck, pancreas, lung, prostate, and brain.