Alpha Tau Medical Ltd. (NASDAQ:DRTS) shares are trading higher after the company announced FDA approval of its IDE application to initiate its multi-center pivotal study for the treatment of recurrent cutaneous Squamous Cell Carcinoma using the Alpha DaRT.
The clinical study, entitled “A Prospective Multicenter, Pivotal, Single Arm, Open Label Clinical Study to Assess the Efficacy and Safety of Intratumoral Alpha DaRT for the Treatment of Patients with Recurrent Cutaneous Squamous Cell Carcinoma” has been approved to enroll up to 86 U.S. patients at up to 20 institutions in the U.S.
"We are very excited about the upcoming commencement of our U.S. pivotal study, undoubtedly our most significant clinical trial to date," said Alpha Tau CEO Uzi Sofer.
Alpha Tau Medical Ltd is a clinical-stage oncology therapeutics company focused on harnessing the innate relative biological effectiveness and short range of alpha particles for use as a localized radiation therapy for solid tumors.
DRTS Price Action: Alpha Tau Medical has traded as high as $20.65 and as low as $4.68 over a 52-week period.
The stock was up 10% at $8.02 at time of publication, according to data from Benzinga Pro.
