Alpha Tau Announces FDA Approval of IDE to Initiate Multi-Center Investigator-Initiated Study of Alpha DaRT® in Immunocompromised Patients with Recurrent cSCC
Alpha Tau Medical Ltd. - Ordinary Shares (DRTS)
Company Research
Source: GlobeNewswire
JERUSALEM, Sept. 20, 2024 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. ("Alpha Tau", or the “Company”) (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT®, announced today 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. The clinical study, which is an investigator-initiated study led by the Winship Cancer Institute of Emory University in Atlanta, has been approved to enroll up to 28 U.S. patients at up to 8 institutions in the U.S., and will focus on patients with recurrent cSCC who have a weakened immune system due to any primary or secondary immunodeficiencies, excluding diabetes. The primary efficacy objective of the study is the objective response rate (ORR) to the treatment, as measured by best overall response
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- Alpha Tau Announces Acceptance Into FDA’s Total Product Life Cycle Advisory Program to Accelerate Market Access to Alpha DaRT® for Patients with Recurrent Glioblastoma MultiformeGlobeNewswire
- Alpha Tau Medical Ltd. (NASDAQ: DRTS) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $9.00 price target on the stock.MarketBeat
- Alpha Tau Treats First Patient with Recurrent Lung CancerGlobeNewswire
DRTS
Sec Filings
- 10/21/24 - Form 6-K
- 10/10/24 - Form 6-K
- 9/20/24 - Form 6-K
- DRTS's page on the SEC website