FDA Events for Alpha Tau Medical (DRTS)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Alpha Tau Medical (DRTS).
Over the past two years, Alpha Tau Medical has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Alpha. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Alpha DaRT - FDA Regulatory Timeline and Events
Alpha DaRT is a drug developed by Alpha Tau Medical for the following indication: Prostate cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Alpha DaRT
- Announced Date:
- April 2, 2025
- Indication:
- Prostate cancer
Announcement
Alpha Tau Medical Ltd. announced that the FDA has approved an Investigational Device Exemption (IDE) application to initiate a pilot study for the treatment of patients with recurrent glioblastoma (GBM) using the Alpha DaRT technology.
AI Summary
Alpha Tau Medical Ltd. announced that the FDA has approved an Investigational Device Exemption (IDE) for a pilot study using its Alpha DaRT technology to treat patients with recurrent glioblastoma, an aggressive type of brain cancer. This new approach is aimed at patients whose tumors are not suitable for surgery and who have already received central nervous system radiation. The IDE approval enables the clinical trial to enroll up to ten U.S. patients and will focus on assessing the feasibility and safety of implanting the Alpha DaRT sources directly into the tumor.
The Alpha DaRT method works by delivering radium-224 inside the tumor, allowing its decay to release high-energy alpha particles that target cancer cells while sparing healthy tissue. This pilot study marks an important step toward offering a new treatment option for patients facing the poor survival outcomes associated with recurrent glioblastoma.
Read Announcement- Drug:
- Alpha DaRT
- Announced Date:
- February 3, 2025
- Indication:
- Prostate cancer
Announcement
Alpha Tau Medical Ltd announced an approval from the U.S. Food and Drug Administration (FDA) of an Investigational Device Exemption (IDE) supplement to the IDE previously announced on Jan 27, 2025, which had approved a clinical study examining the combination of Alpha DaRT and first-line chemotherapy in 12 patients with newly diagnosed metastatic pancreatic cancer, allowing expansion of the clinical trial to a broader group of pancreatic cancer patients.
AI Summary
Alpha Tau Medical Ltd recently announced that the U.S. Food and Drug Administration (FDA) approved an Investigational Device Exemption (IDE) supplement. This supplement allows the company to expand its clinical trial for treating pancreatic cancer by combining its alpha-radiation therapy, Alpha DaRT®, with first-line chemotherapy. Originally, the clinical study focused on 12 patients with newly diagnosed metastatic pancreatic cancer. With the new FDA approval, the trial will now include an additional cohort of patients with locally advanced pancreatic cancer. Each cohort will be increased to 15 patients, resulting in a total of 30 patients across up to 10 U.S. clinical trial sites. This expansion brings Alpha Tau one step closer to studying the potential benefits of its innovative treatment across a broader range of pancreatic cancer patients.
Read Announcement- Drug:
- Alpha DaRT
- Announced Date:
- October 10, 2024
- Indication:
- Prostate cancer
Announcement
Alpha Tau Medical Ltd. announced that its first patient with recurrent lung cancer has been treated, in a clinical trial at Hadassah Medical Center in Jerusalem, Israel.
AI Summary
Alpha Tau Medical Ltd. announced a major breakthrough in lung cancer treatment. The company treated its first patient with recurrent lung cancer as part of a clinical trial at Hadassah Medical Center in Jerusalem, Israel. This trial focuses on patients with recurrent tumors in the mediastinum, the area between the lungs. It aims to evaluate the safety and feasibility of using Alpha Tau’s innovative alpha-radiation therapy, Alpha DaRT®, delivered via an endobronchial ultrasound (EBUS) procedure. The study will monitor successful placement of the radioactive sources, track any treatment-related adverse events, and assess tumor response over time. This approach combines precision targeted therapy that may reduce damage to surrounding healthy tissues. Researchers are hopeful that this new method could offer a promising treatment option for lung cancer patients with limited alternatives, paving the way for further exploration of alpha-radiation therapies in challenging cancer cases.
Read Announcement- Drug:
- Alpha DaRT
- Announced Date:
- September 20, 2024
- Indication:
- Prostate cancer
Announcement
Alpha Tau Medical Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) application to initiate a multi-center study for the treatment of recurrent cutaneous Squamous Cell Carcinoma (cSCC) in immunocompromised patients using the Alpha DaRT.
AI Summary
Alpha Tau Medical Ltd. has announced that the FDA has approved an Investigational Device Exemption (IDE) application for a new multi-center study. This study will investigate the use of their innovative Alpha DaRT treatment for recurrent cutaneous Squamous Cell Carcinoma (cSCC) in immunocompromised patients. Led by the Winship Cancer Institute of Emory University, the trial plans to enroll up to 28 patients across eight U.S. institutions. The study will focus on patients who have recurrent cSCC and weakened immune systems due to conditions other than diabetes.
The primary goal is to evaluate the treatment’s effectiveness by measuring the objective response rate, while also observing progression-free survival, overall survival, and local tumor control over twelve months. This initiative aims to provide a new treatment option for a vulnerable patient group with limited alternatives.
Read Announcement
Alpha Tau Medical FDA Events - Frequently Asked Questions
As of now, Alpha Tau Medical (DRTS) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Alpha Tau Medical (DRTS) has reported FDA regulatory activity for Alpha DaRT.
The most recent FDA-related event for Alpha Tau Medical occurred on April 2, 2025, involving Alpha DaRT. The update was categorized as "FDA Approval," with the company reporting: "Alpha Tau Medical Ltd. announced that the FDA has approved an Investigational Device Exemption (IDE) application to initiate a pilot study for the treatment of patients with recurrent glioblastoma (GBM) using the Alpha DaRT technology."
Currently, Alpha Tau Medical has one therapy (Alpha DaRT) targeting the following condition: Prostate cancer.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:DRTS) was last updated on 7/11/2025 by MarketBeat.com Staff
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