Interim results from Phase 2b clinical trial of RAD 101 showed 92% of evaluable participants met the primary endpoint of MRI concordance in imaging study of patients with brain metastases Interim data from additional Cohorts of the Phase 1 clinical trial of RAD 202 and RAD 204 in advanced solid tumors are expected in mid-2026 Cash and cash equivalents of approximately $34.52 million provide runway into 2027 to advance pipeline of high value radiotherapeutic programs through key clinical and regulatory mile ...

Core Insights - Radiopharm Theranostics Limited (NASDAQ:RADX) is experiencing a significant increase in stock price, trading at $10.27, up 141.31%, approaching its 52-week high of $11.00 [7] Group 1: Clinical Trial Updates - The company shared interim data from its U.S. Phase 2b imaging trial of RAD 101, which targets fatty acid synthase (FASN) for diagnosing recurrent brain metastases, showing that 92% (11 out of 12) of patients achieved concordance with MRI as assessed by PET imaging [2][4] - The interim analysis indicated significant and selective tumor uptake in brain metastases, confirming metabolic activity compared to unclear MRI findings [3] Group 2: Market Potential and Future Plans - The CEO stated that the interim data strengthens confidence in the Phase II trial's success and lays a foundation for a pivotal study by the end of 2026, with independent assessments estimating RAD 101's U.S. market opportunity at over $500 million annually [4] - The company has achieved 50% patient enrollment in the Phase 2b trial evaluating RAD 101 [4] Group 3: Regulatory Designations and Additional Trials - RAD 101 has received FDA Fast Track Designation for distinguishing recurrent disease from treatment effects in brain metastases, with over 300,000 patients diagnosed annually in the U.S. [5] - Additionally, the company secured Australian approval to initiate its First-In-Human Phase 1 clinical trial of RAD 402 for metastatic or locally advanced prostate cancer [6]

Core Insights - Radiopharm Theranostics has received approval from the Bellberry Human Research Ethics Committee (HREC) in Australia to initiate a First-In-Human (FIH) Phase 1 clinical trial for RAD 402, a radiotherapeutic targeting KLK3 for metastatic or locally advanced prostate cancer [1][4] Company Overview - Radiopharm Theranostics is a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for high unmet medical needs, listed on ASX (RAD) and NASDAQ (RADX) [5] - The company has a diverse pipeline that includes one Phase 2 and four Phase 1 trials targeting various solid tumors, including lung, breast, and brain metastases [5] Product Details - RAD 402 is an anti-KLK3 monoclonal antibody radiolabelled with the radionuclide 161Tb, designed for the treatment of prostate cancer, with KLK3 being a key biomarker for the disease [2] - Preclinical studies have demonstrated strong tumor targeting and a favorable excretion profile for RAD 402, supporting its potential effectiveness [3] Clinical Development - The initiation of the Phase 1 trial for RAD 402 is significant as it is reportedly the first company-sponsored therapeutic trial utilizing 161Tb, highlighting the innovative approach of targeting KLK3 in advanced prostate cancer [4]

Core Insights - Radiopharm Theranostics has completed the preclinical data package for RAD 402, an anti-Kallikrein Related Peptidase 3 (KLK3) monoclonal antibody radiotherapeutic, and is preparing to initiate a Phase 1 clinical trial for prostate cancer in the second half of 2025 [1][2][3] Company Overview - Radiopharm Theranostics is a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for high unmet medical needs, listed on ASX (RAD) and NASDAQ (RADX) [5] - The company has a diverse pipeline that includes one Phase 2 and three Phase 1 trials targeting various solid tumors, including lung, breast, and brain cancers [5] Partnership and Development - A supply agreement has been signed with Cyclotek to radiolabel RAD 402 with Terbium-161 (Tb), which is crucial for the upcoming Phase 1 clinical trial [1][3] - Cyclotek, a leading radiopharmaceutical manufacturer in Australia and New Zealand, will produce and provide doses of Tb-labeled RAD 402 [6][4] Therapeutic Focus - RAD 402 is designed to target KLK3, which is highly expressed in prostate tissue, potentially leading to improved therapeutic efficacy due to the unique properties of Tb compared to other radionuclides [2][4] - The partnership aims to enhance patient outcomes by improving the accessibility of radiopharmaceuticals [7][8]