Summary of Radiopharm Theranostics (NasdaqCM:RADX) Update / Briefing December 15, 2025 Company Overview - **Company**: Radiopharm Theranostics - **Ticker**: RADX - **Focus**: Development of imaging agents for brain metastases, specifically RAD-101 targeting fatty acid synthase Key Industry Insights - **Target Market**: Brain metastases primarily from lung cancer, breast cancer, and melanoma, which account for approximately 90% of cases [3][4] - **Current Treatment Challenges**: Difficulty in differentiating between tumor recurrence and treatment-related effects post-stereotactic radiosurgery (SRS) [4][11] - **Unmet Medical Need**: High demand for effective imaging solutions to accurately assess brain metastases and guide treatment decisions [11][19] Core Findings and Data - **RAD-101 Performance**: Preclinical data shows RAD-101 has superior uptake and tumor-to-brain ratios compared to traditional imaging agents like 18F FTG in various cancer models [2] - **Phase IIB Study**: Currently recruiting 30 patients in the U.S. to evaluate RAD-101's effectiveness in patients with suspected brain metastases post-SRS [4][5] - **Survival Correlation**: Patients with a standardized uptake value (SUV) greater than 2 showed significantly shorter overall survival, indicating the potential prognostic value of RAD-101 [6][8] - **Market Potential**: Estimated market size of $500 million in the U.S. for RAD-101, with a projected price of $4,800-$5,000 per dose [46][56] Competitive Landscape - **Lack of Competition**: Currently, no other imaging agents specifically targeting brain metastases are in clinical development, providing RAD-101 a unique market position [49][50] - **Differentiation from Other Agents**: RAD-101 targets fatty acid metabolism, while competitors focus on amino acid metabolism, addressing different patient populations [48][50] Future Plans - **Phase III Study**: Anticipated to include around 150 patients, focusing on sensitivity and specificity as primary endpoints [40][41] - **Longitudinal Studies**: Plans to conduct longitudinal scans to establish a truth standard for imaging efficacy [77] - **Potential for Therapeutic Version**: Exploration of developing a therapeutic isotope version of RAD-101 is underway [64] Additional Considerations - **Combination with MRI**: Initial strategy involves using RAD-101 in conjunction with MRI to enhance diagnostic accuracy [45][68] - **Patient Management Improvement**: Aim to enable earlier diagnosis and treatment of tumor recurrence, potentially improving patient outcomes [54][56] - **Safety Concerns**: Emphasis on the importance of accurate imaging to avoid unnecessary SRS procedures, which carry risks of side effects [65][67] Conclusion Radiopharm Theranostics is positioned to address a significant unmet need in the imaging of brain metastases with RAD-101, showing promising preclinical results and a clear path towards clinical development. The company is focused on establishing its market presence while ensuring patient safety and improving treatment outcomes through innovative imaging solutions.

We recently published 7 Best ASX Stocks to Buy Right Now.  Radiopharm Theranostics Limited (NASDAQ:RADX) is one of the best ASX stocks. Radiopharm Theranostics Limited (NASDAQ:RADX) is a biotechnology company developing treatments for ailments such as brain metastasis and prostate cancer. B. Riley lowered its share price target for the firm to $13 from $15 and kept a Buy rating for the shares on November 26th. As part of its coverage, the research firm discussed Radiopharm Theranostics Limited (NASDAQ:RAD ...

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 ...

Core Insights - The interim analysis of RAD 101 shows that 92% of evaluable patients achieved concordance with MRI imaging, indicating significant tumor uptake in brain metastases [1][2] - The company plans to initiate a pivotal study by the end of 2026, bolstered by the positive interim data from the Phase 2b trial [3] Company Overview - Radiopharm Theranostics is a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for high unmet medical needs [1][10] - The company is listed on ASX (RAD) and NASDAQ (RADX) and has a pipeline that includes one Phase 2 and four Phase 1 trials targeting various solid tumors [10] Clinical Trial Details - The Phase 2b clinical trial is evaluating the diagnostic performance of RAD 101 in 30 individuals with confirmed recurrent brain metastases from solid tumors [8] - The primary objective is to assess concordance between RAD 101 positive lesions and those seen in conventional MRI imaging [8] Market Opportunity - The U.S. market opportunity for RAD 101 is estimated to exceed $500 million annually, positioning it among the top three imaging agents in the market [3] - Over 300,000 patients are diagnosed with brain metastases annually in the U.S., highlighting a significant patient population for RAD 101 [4][3] Technology and Innovation - RAD 101 is a novel imaging agent targeting fatty acid synthase (FASN), which is overexpressed in many solid tumors, including brain metastases [9] - The integration of RAD 101 PET with standard MRI could enhance patient management and treatment decisions for brain metastases [3]

In this piece, we will look at the best ASX stocks to buy.While the Federal Reserve cut interest rates in the US a couple of days back, in Australia, the trend appears to be moving in the opposite direction. RBA Governor Michele Bullock, in a statement on December 9th, commented that “I don’t think there are interest rate cuts in the horizon for the foreseeable future.” The official added that the question was whether “is it just an extended hold from here or is it, um, possibility of a rate rise.” The Rese ...

For personal use only NASDAQ: RADX / ASX: RAD Annual General Meeting NOVEMBER 20 , 2025 Notice & Disclaimer The information in this presentation does not constitute personal investment advice. The presentation is not intended to be comprehensive or provide all information required by investors to make an informed decision on any investment in Radiopharm Theranostics Ltd ACN 647 877 889 (Company). In preparing this presentation, the Company did not take into account the investment objectives, financial situa ...

RAD 402 is a humanized IgG1 internalized by prostate cells, binding KLK3 with high affinity Tb-161 antitumor activity driven by the dual emission of beta particles and Auger electrons SYDNEY, Nov. 18, 2025 (GLOBE NEWSWIRE) -- 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 that it has been granted Bellberry Human Research Ethics Co ...

Early patient data from Phase 2b clinical trial showed significant and selective tumor uptake in brain metastases compared to MRI Phase 2b clinical trial expected to complete enrollment and have topline data in 1H26 SYDNEY, Nov. 17, 2025 (GLOBE NEWSWIRE) -- 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 that the Phase 2b trial eval ...

Data Safety Monitoring Committee approves advancing to a higher dose of 90mCi The first two Cohorts’ patients show tumor uptake and a favourable safety profile SYDNEY, Nov. 12, 2025 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX: RAD, Nasdaq: RADX, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced the completion of enrollment for the second cohort of patients in the ...

Core Insights - The Depositary Receipts Virtual Investor Conference ("dbVIC") was held on November 4th, 2025, and the presentations are now available for online viewing [1][2] - The company presentations will be accessible 24/7 for a duration of 90 days, allowing investors, advisors, and analysts to download materials [2] Company Presentations - The following companies presented at the conference: - HUTCHMED (China) Limited (AIM: HCM, NASDAQ: HCM, HKEX: 13) - First Pacific Company Ltd (HKEX: 142, OTC: FPAFY) - Viomi Technology Co., Ltd (NASDAQ: VIOT) - Epiroc AB (Nasdaq Stockholm: EPIA, OTC: EPOAY) - Yiren Digital Ltd. (NYSE: YRD) - Belite Bio, Inc (NASDAQ: BLTE) - Deutsche Lufthansa AG (FRA: LHA, OTCQX: DLAKY) - Lotus Technology Inc (NASDAQ: LOT) - 51Talk Online Education Group (NYSE American: COE) - Radiopharm Theranostics Ltd (Nasdaq: RADX; ASX: RAD) - Repsol S.A (BME: REP, OTCQX: REPYY) [3] About Virtual Investor Conferences - Virtual Investor Conferences (VIC) is recognized as the leading proprietary investor conference series, providing an interactive platform for publicly traded companies to present directly to investors [4] - VIC offers a real-time investor engagement solution, designed to enhance investor access and replicate the components of an on-site investor conference [5]