Radiopharm Theranostics (NASDAQ:RADX) announced interim findings from its Phase 2b clinical trial evaluating RAD 101, an imaging agent designed to detect recurrent brain metastases, according to a company press release.
The second interim analysis, which included 20 patients, showed that 90% achieved concordance between PET imaging results and MRI scans, meeting the study’s primary endpoint. RAD 101 is a small-molecule imaging agent that targets fatty acid synthase and is radiolabeled with Fluorine-18 to help diagnose suspected recurrent brain metastases originating from solid tumors.
The trial update comes as the company’s shares have faced pressure, with the stock declining about 31% over the past six months. Radiopharm currently has a market capitalization of around $49 million and maintains a current ratio of 3.01, suggesting solid short-term liquidity.
Among the first five patients with six-month follow-up data and biopsy confirmation, results indicated a positive trend in sensitivity and specificity—secondary objectives of the study. Imaging findings showed tumor uptake in brain metastases consistent with MRI observations.
The ongoing U.S. multicenter, open-label, single-arm study is assessing the diagnostic performance of RAD 101 in 30 patients with confirmed recurrent brain metastases from solid tumors. Its primary goal is to measure concordance between lesions identified as positive by RAD 101 and those detected through conventional MRI imaging.
RAD 101 has received Fast Track designation from the U.S. Food and Drug Administration to support its development as a tool to distinguish between recurrent disease and treatment-related effects in brain metastases. More than 300,000 people in the United States are diagnosed with cerebral metastases each year.
Radiopharm expects to report final results from the full 30-patient trial by June 2026. The company also plans to host a webinar discussing the interim findings at 6:00 p.m. EST today.
Radiopharm Theranostics is a clinical-stage biopharmaceutical company focused on developing radiopharmaceutical therapies and diagnostics. Its pipeline currently includes one Phase 2 and four Phase 1 clinical trials targeting various solid tumors, including lung, breast and brain metastases.
In other developments, Radiopharm recently dosed the first patient in its Phase 1/2a trial evaluating 177Lu-BetaBart, a radiotherapeutic agent that targets the B7-H3 immune checkpoint molecule. The study aims to assess the drug’s safety, biodistribution and radiation dosimetry and plans to enroll 61 participants with advanced solid tumors, including prostate, colorectal, lung and breast cancers.
The company also increased its ownership stake in Radiopharm Ventures from 75% to 87.5%. The joint venture, established with The University of Texas MD Anderson Cancer Center, focuses on developing radiopharmaceutical cancer therapies, including the lead candidate Betabart. These initiatives reflect Radiopharm’s continued efforts to advance new treatment approaches for cancer.