Radiopharm Theranostics Ltd (RADX)

Radiopharm reports 90% concordance in interim results for RAD 101 brain metastases trialMarch 24, 2026 10:50 AM
IH Market News
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.Radiopharm Theranostics stock price

Original: Radiopharm reports 90% concordance in interim results for RAD 101 brain metastases trial

$RADX: Good news out......... now showing $9.90

After the halt.

Worth keeping an eye out on

GO $RADX

Back out $15.50 this round 

These results are considered promising because they suggest RAD 101 could significantly improve the diagnosis of recurrent brain metastases, allowing for better treatment decisions and potentially better patient outcomes. The company has received FDA Fast Track designation for this agent, and the market opportunity in the U.S. is estimated to exceed $500 million annually.

Round 2 back in $13.57 with a mental stop same price 

4.26014.210-0.47%+233.57%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. "Integrating RAD 101 PET (Pivalate) with standard MRI has the potential to transform patient management and enable better treatment decisions for the more than 300,000 patients in the U.S. diagnosed with brain metastases each year. 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 and RAD 101 has received U.S. Food and Drug Administration (FDA) Fast Track Designation to distinguish between recurrent disease and treatment effect of brain metastases originating from solid tumors of different origin, including leptomeningeal disease.

 the stock having traded between a low of $3.50 and a high of $50.82 over the past year

Probably goes up 1,000 percent on brain. Cancer 92% positive result news. Hot one maybe $50 possible 

$22 off to $30

Out at $14.53 from $6s - 

Go to $30 based on results and float.. eractive charts, live options flow, and more. https://investorshub.advfn.com/secure/reguser3.aspx4.50 0.24 (5.63%)Pre MarketLast Updated:04:25:03Radiopharm Theranostics Achieves Primary Endpoint in 92% of Patients at Interim Analysis of RAD 101 Phase 2b Imaging Trial in Brain MetastasesDecember 15 2025 - 7:00AM
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Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced interim data from the first twelve patients in its U.S. Phase 2b clinical imaging trial of RAD 101 in brain metastases. RAD 101 is Radiopharm’s novel, 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. “Integrating RAD 101 PET (Pivalate) with standard MRI has the potential to transform patient management and enable better treatment decisions for the more than 300,000 patients in the U.S. diagnosed with brain metastases each year. 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 and RAD 101 has received U.S. Food and Drug Administration (FDA) Fast Track Designation to distinguish between recurrent disease and treatment effect of brain metastases originating from solid tumors of different origin, including leptomeningeal disease.In the U.S. alone, there are more than 300,000 patients diagnosed annually with cerebral metastases. The incidence of Intracranial Metastatic Disease (IMD) continues to increase, in part, due to improvements in systemic therapy resulting in a more durable control of the Primary tumor.
¹ Concordance definition: “Agreement or correlation between MRI and Pivalate images”Contrast-enhanced Magnetic Resonance Imaging (CE-MRI) is the preferred method for imaging IMD, but has limitations, particularly in follow-up surveillance scans to optimise patient care.²WEBINAR DETAILS

$6.67

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RADX: Whelp, for what it's worth, here's the new RADX iHub BOARD!!!! (They make cute DIAGNOSTIC --- & potentially THERAPEUTIC, as well --- Medical gadgets that can enter tiny, obscure, sites in our Homo sapiens BODIES; and then hopefully determine what-the-heck bad things are transpiring in there, & maybe fix them to boot!!!)