Alpha Tau Submits First Pre-Market Approval Module to the FDA for Alpha DaRT® for the Treatment of Recurrent Cutaneous Squamous Cell Carcinoma (cSCC) [Yahoo! Finance]
Alpha Tau Medical Ltd. - Ordinary Shares (DRTS)
Company Research
Source: Yahoo! Finance
- Flexible modular submission framework granted to Alpha Tau by the FDA allows for streamlined review and feedback from the FDA as each module is submitted - - Module submitted in parallel to execution of ReSTART pivotal study ( Re current S CC T reatment with A lpha DaRT R adiation T herapy), which is expected to complete recruiting patients in Q1 2026 - JERUSALEM, Jan. 05, 2026 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd . (Nasdaq: DRTS, DRTSW) ("Alpha Tau", or the “Company”), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT ® today announced the submission of the first module of its pre-market approval (PMA) application to the U.S. Food and Drug Administration (FDA), following the FDA's previous decision to allow the Company to use the more flexible modular approach. The Company submitted the module as part of an application for the use of Alpha DaRT in treating recurrent cutaneous squamous cell carcinoma (cSCC), the second most common form of skin cance
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News
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- Alpha Tau Reports New Positive Results in Two Upcoming Presentations at ASCO GI 2026 Symposium Showcasing Immune-Preservation and High Disease Control in Montreal Pancreatic Cancer Alpha DaRT® Study [Yahoo! Finance]Yahoo! Finance
- Alpha Tau Reports New Positive Results in Two Upcoming Presentations at ASCO GI 2026 Symposium Showcasing Immune-Preservation and High Disease Control in Montreal Pancreatic Cancer Alpha DaRT® StudyGlobeNewswire
- Throwing Precision Darts: The Company Leading Next Evolution of Cancer Radiation [Globe and Mail, The (Toronto, Canada)]Globe and Mail, The
- Alpha Tau Submits First Pre-Market Approval Module to the FDA for Alpha DaRT® for the Treatment of Recurrent Cutaneous Squamous Cell Carcinoma (cSCC)GlobeNewswire
DRTS
Earnings
- 11/20/25 - Beat
DRTS
Sec Filings
- 1/14/26 - Form 144
- 1/12/26 - Form 144
- 1/9/26 - Form 144
- DRTS's page on the SEC website