Radiopharm Theranostics Limited (NASDAQ:RADX) stock is trading higher on Monday, with a session volume of 21.33 million compared to the average volume of 26.81 thousand, as per data from Benzinga Pro.
On Monday, Radiopharm Theranostics shared interim data from the first twelve patients in its U.S. Phase 2b imaging trial of RAD 101 in brain metastases.
RAD 101 is a small-molecule imaging agent targeting fatty acid synthase (FASN) and radiolabelled with Fluorine-18 for the diagnosis of suspected recurrent brain metastases from solid tumors of different origins, also known as the Pivalate technology.
The interim analysis showed that 92% (11/12) of the patients treated with RAD 101 achieved concordance with MRI (the primary endpoint) as assessed by PET imaging of brain metastases.
The results showed significant and selective tumor uptake in the brain metastases. Images confirm metabolic activity in brain metastases compared to equivocal MRI findings.
“These compelling interim data significantly strengthen confidence in the success of our Phase II trial of RAD 101 and provide a strong foundation for initiating a pivotal study by the end of 2026,” said Riccardo Canevari, CEO and managing director of Radiopharm Theranostics…Independent commercial assessments estimate RAD 101’s U.S. market opportunity at more than $500 million annually, positioning it to become one of the top three imaging agents in the market.”
The company recently achieved 50% patient enrollment in the Phase 2b trial evaluating RAD 101 imaging in brain metastases.
RAD 101 has received U.S. Food and Drug Administration (FDA) Fast Track Designation to distinguish recurrent disease from the treatment effect in brain metastases originating from solid tumors of different origins, including leptomeningeal disease.
In the U.S. alone, there are more than 300,000 patients diagnosed annually with cerebral metastases.
In November, Radiopharm Theranostics secured Australian approval to initiate its First-In-Human (FIH) Phase 1 clinical trial of RAD 402 for the treatment of metastatic or locally advanced prostate cancer.
RAD 402 is an anti-KLK3 monoclonal antibody radiolabelled with the radionuclide 161Tb for the treatment of prostate cancer.
RADX Price Action: Radiopharm Theranostics shares were up 141.31% at $10.27 at the time of publication on Monday. The stock is approaching its 52-week high of $11.00, according to Benzinga Pro data.
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