Radiopharm Advances 177Lu-RAD202 Clinical Trial to 130mCi
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Apr 08 2026
0mins
Should l Buy RADX?
Radiopharm announced that it has received a recommendation from the Data Safety and Monitoring Committee, or DSMC, to advance its clinical-stage radiotherapeutic asset, 177Lu-RAD202, to the next dose level of 130mCi in the Phase 1 'HEAT' clinical trial in patients with Human Epidermal Growth Factor Receptor 2-positive advanced solid tumors. The DSMC is a multidisciplinary committee that conducts detailed reviews of study data, discusses potential safety events and provides recommendations regarding trial continuation.
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Analyst Views on RADX
Wall Street analysts forecast RADX stock price to rise
3 Analyst Rating
3 Buy
0 Hold
0 Sell
Strong Buy
Current: 4.500
Low
15.00
Averages
20.33
High
30.00
Current: 4.500
Low
15.00
Averages
20.33
High
30.00
About RADX
Radiopharm Theranostics Limited is an Australia-based clinical-stage radiotherapeutics company developing a platform of radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need. The Company has a pipeline of highly differentiated platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer. The clinical program includes one Phase II and three Phase I trials in a variety of solid tumor cancers including lung, breast, and brain. Its technologies include Nano-mAbs, Pivalate, AVB6 Integrin, PSA-mAb, and PTPu. Nano-mAbs is a novel radiopharmaceutical platform made using genetic engineered camelid derived single domain antibodies (sdAb) labelled with a radioisotope of therapeutic radiation. Pivalate is an 18F-FPIA radiotracer, based on a short chain carbohydrate which utilizes the early steps of fatty acid oxidation.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Investor Material Downloads: Investors can download materials from participating companies such as Lotus Technology and Viomi Technology, which fosters improved interaction and communication between investors and companies.
- Ongoing Availability: All company presentations will be accessible 24/7 for the next 90 days, meeting investors' needs for flexibility while providing companies with ongoing opportunities to showcase their business.
- Enhanced Investor Relations: Virtual Investor Conferences facilitate real-time investor engagement solutions, enabling companies to connect with investors more efficiently, thereby improving the effectiveness of investor relations management.
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- Participating Companies: The agenda includes presentations from Lotus Technology Inc., Viomi Technology Co., Ltd, and Belite Bio, Inc., showcasing Deutsche Bank's expertise in managing cross-border equity structures, which is expected to enhance its influence in the global market.
- Participation Fee: The conference is free for participants, with pre-registration suggested, reflecting Deutsche Bank's commitment to providing convenient services for investors and further solidifying its leadership in investor relations management.
- Service Range: Deutsche Bank specializes not only in the administration of depositary receipts but also offers a wide array of financial services, including complex securitizations, project financing, and debt restructuring, demonstrating its comprehensive strength in the global financial services market.
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Radiopharm Receives Positive DSMC Recommendation to Advance Clinical Trial
- Clinical Trial Progress: Radiopharm Theranostics announced that its clinical-stage radiotherapeutic asset 177Lu-RAD202 received a positive recommendation from the Data Safety and Monitoring Committee, allowing an increase in dosage to 130mCi in the Phase 1 ‘HEAT’ trial, indicating favorable safety and efficacy.
- Accelerated Dose Escalation: CEO Riccardo Canevari stated that the rapid progress of the trial has enabled the acceleration of dose escalation from Cohort 2 to Cohort 3, with plans to complete the Phase 1 dose escalation by the end of 2026, further advancing product development.
- HER2 Targeted Therapy: 177Lu-RAD202 is a proprietary single-domain monoclonal antibody targeting HER2-positive advanced solid tumors, with HER2 overexpressed in breast cancer and several other solid tumors, representing a validated target in oncology with significant clinical application potential.
- Multiple Clinical Trials: Radiopharm is currently conducting Phase 1 and Phase 2 trials across various clinical centers in Australia, covering multiple solid tumors including lung, breast, prostate, and brain cancers, showcasing the company's extensive portfolio and growth potential in innovative radiopharmaceuticals.
See More
Radiopharm Signs Supply Agreement with Siemens Healthineers
- Supply Agreement Signed: Radiopharm Theranostics Ltd. has entered into a supply agreement with Siemens Healthineers to produce RAD101, a novel imaging small molecule aimed at diagnosing suspected recurrent brain metastases from solid tumors, marking a significant advancement in tumor imaging.
- Clinical Trial Support: Under the agreement, Siemens Healthineers will manufacture and distribute Fluorine-18-labeled RAD101 to support Radiopharm's upcoming Phase 3 trial in the U.S., which is expected to enhance the company's competitive position in the market.
- Clinical Data Highlights: Interim Phase 2b data demonstrated significant and selective tumor uptake in brain metastases with a 90% concordance with MRI, successfully meeting the primary endpoint and showcasing the potential clinical value of the product.
- Stock Performance: Radiopharm's shares closed at $4.42 on Monday, up 0.45%, reflecting market optimism regarding the new agreement and clinical progress, potentially laying the groundwork for future stock price growth.
See More
Radiopharm Initiates Phase 1 Trial of RAD 402 for Prostate Cancer
- Trial Launch: Radiopharm Theranostics announced that the first patient has been dosed in the Phase 1 clinical trial of RAD 402, which aims to evaluate safety and preliminary efficacy for prostate cancer, marking a significant advancement in the company's innovative oncology treatments.
- Targeting Mechanism Innovation: RAD 402 is a monoclonal antibody targeting KLK3, radiolabelled with Terbium 161, with preclinical data showing strong tumor targeting in mouse xenografts while exhibiting minimal bone marrow uptake and expected hepatic clearance, indicating its potential for clinical application.
- Dose Escalation Design: The Phase 1 trial employs a dose escalation design to determine the Maximum Tolerated Dose (MTD) and recommended Phase 2 Dose (RP2D), laying the groundwork for future clinical expansion and reflecting the company's commitment to this program and its patients.
- Partner Support: Radiopharm CEO Riccardo Canevari expressed gratitude to TerThera and Cyclotek for their support in supplying Tb161, radiolabelling, and distributing RAD 402, highlighting the importance of collaboration in advancing innovative therapeutic solutions.
See More
Radiopharm's First Radiotherapeutic Agent Enters Clinical Trials
- Clinical Trial Launch: Radiopharm Theranostics announced the first dosing of its radiotherapeutic agent 177Lu-BetaBart (RV-01) in a First-In-Human Phase 1/2a clinical trial, marking a significant milestone that is expected to provide new treatment options for patients with advanced solid tumors.
- Mechanism of Action: 177Lu-BetaBart is a monoclonal antibody targeting B7-H3, which has shown potential for tumor shrinkage and prolonged survival in preclinical studies, particularly demonstrating good targeting in various tumor types including prostate, pancreatic, and breast cancers.
- Trial Scale: The clinical trial aims to enroll 61 eligible participants across multiple cancer types, including castrate-resistant prostate cancer and small cell lung cancer, with the goal of assessing the safety and pharmacokinetics of 177Lu-BetaBart.
- Strategic Implications: This study not only showcases Radiopharm's innovative capabilities in the development of radiopharmaceuticals but also positions the company for a significant competitive advantage in the highly competitive oncology market, potentially driving future commercial growth.
See More
Virtual Investor Conference Presentations Now Available Online
- Conference Content Release: Presentations from the Depositary Receipts Virtual Investor Conference (dbVIC) held on April 28, 2026, are now available for online viewing, enhancing accessibility and transparency of information for investors.
- Investor Material Downloads: Investors can download materials from participating companies such as Lotus Technology and Viomi Technology, which fosters improved interaction and communication between investors and companies.
- Ongoing Availability: All company presentations will be accessible 24/7 for the next 90 days, meeting investors' needs for flexibility while providing companies with ongoing opportunities to showcase their business.
- Enhanced Investor Relations: Virtual Investor Conferences facilitate real-time investor engagement solutions, enabling companies to connect with investors more efficiently, thereby improving the effectiveness of investor relations management.
See More
Deutsche Bank to Host Depositary Receipts Investor Conference
- Conference Details: Deutsche Bank is set to host the Depositary Receipts Virtual Investor Conference on April 28, 2026, featuring live presentations from international companies based in Australia, China, Hong Kong, Portugal, Netherlands, Cayman Islands, and France, aimed at attracting a diverse range of investors and analysts.
- Participating Companies: The agenda includes presentations from Lotus Technology Inc., Viomi Technology Co., Ltd, and Belite Bio, Inc., showcasing Deutsche Bank's expertise in managing cross-border equity structures, which is expected to enhance its influence in the global market.
- Participation Fee: The conference is free for participants, with pre-registration suggested, reflecting Deutsche Bank's commitment to providing convenient services for investors and further solidifying its leadership in investor relations management.
- Service Range: Deutsche Bank specializes not only in the administration of depositary receipts but also offers a wide array of financial services, including complex securitizations, project financing, and debt restructuring, demonstrating its comprehensive strength in the global financial services market.
See More
Radiopharm Receives Positive DSMC Recommendation to Advance Clinical Trial
- Clinical Trial Progress: Radiopharm Theranostics announced that its clinical-stage radiotherapeutic asset 177Lu-RAD202 received a positive recommendation from the Data Safety and Monitoring Committee, allowing an increase in dosage to 130mCi in the Phase 1 ‘HEAT’ trial, indicating favorable safety and efficacy.
- Accelerated Dose Escalation: CEO Riccardo Canevari stated that the rapid progress of the trial has enabled the acceleration of dose escalation from Cohort 2 to Cohort 3, with plans to complete the Phase 1 dose escalation by the end of 2026, further advancing product development.
- HER2 Targeted Therapy: 177Lu-RAD202 is a proprietary single-domain monoclonal antibody targeting HER2-positive advanced solid tumors, with HER2 overexpressed in breast cancer and several other solid tumors, representing a validated target in oncology with significant clinical application potential.
- Multiple Clinical Trials: Radiopharm is currently conducting Phase 1 and Phase 2 trials across various clinical centers in Australia, covering multiple solid tumors including lung, breast, prostate, and brain cancers, showcasing the company's extensive portfolio and growth potential in innovative radiopharmaceuticals.
See More
Radiopharm Signs Supply Agreement with Siemens Healthineers
- Supply Agreement Signed: Radiopharm Theranostics Ltd. has entered into a supply agreement with Siemens Healthineers to produce RAD101, a novel imaging small molecule aimed at diagnosing suspected recurrent brain metastases from solid tumors, marking a significant advancement in tumor imaging.
- Clinical Trial Support: Under the agreement, Siemens Healthineers will manufacture and distribute Fluorine-18-labeled RAD101 to support Radiopharm's upcoming Phase 3 trial in the U.S., which is expected to enhance the company's competitive position in the market.
- Clinical Data Highlights: Interim Phase 2b data demonstrated significant and selective tumor uptake in brain metastases with a 90% concordance with MRI, successfully meeting the primary endpoint and showcasing the potential clinical value of the product.
- Stock Performance: Radiopharm's shares closed at $4.42 on Monday, up 0.45%, reflecting market optimism regarding the new agreement and clinical progress, potentially laying the groundwork for future stock price growth.
See More
Radiopharm Initiates Phase 1 Trial of RAD 402 for Prostate Cancer
- Trial Launch: Radiopharm Theranostics announced that the first patient has been dosed in the Phase 1 clinical trial of RAD 402, which aims to evaluate safety and preliminary efficacy for prostate cancer, marking a significant advancement in the company's innovative oncology treatments.
- Targeting Mechanism Innovation: RAD 402 is a monoclonal antibody targeting KLK3, radiolabelled with Terbium 161, with preclinical data showing strong tumor targeting in mouse xenografts while exhibiting minimal bone marrow uptake and expected hepatic clearance, indicating its potential for clinical application.
- Dose Escalation Design: The Phase 1 trial employs a dose escalation design to determine the Maximum Tolerated Dose (MTD) and recommended Phase 2 Dose (RP2D), laying the groundwork for future clinical expansion and reflecting the company's commitment to this program and its patients.
- Partner Support: Radiopharm CEO Riccardo Canevari expressed gratitude to TerThera and Cyclotek for their support in supplying Tb161, radiolabelling, and distributing RAD 402, highlighting the importance of collaboration in advancing innovative therapeutic solutions.
See More
Radiopharm's First Radiotherapeutic Agent Enters Clinical Trials
- Clinical Trial Launch: Radiopharm Theranostics announced the first dosing of its radiotherapeutic agent 177Lu-BetaBart (RV-01) in a First-In-Human Phase 1/2a clinical trial, marking a significant milestone that is expected to provide new treatment options for patients with advanced solid tumors.
- Mechanism of Action: 177Lu-BetaBart is a monoclonal antibody targeting B7-H3, which has shown potential for tumor shrinkage and prolonged survival in preclinical studies, particularly demonstrating good targeting in various tumor types including prostate, pancreatic, and breast cancers.
- Trial Scale: The clinical trial aims to enroll 61 eligible participants across multiple cancer types, including castrate-resistant prostate cancer and small cell lung cancer, with the goal of assessing the safety and pharmacokinetics of 177Lu-BetaBart.
- Strategic Implications: This study not only showcases Radiopharm's innovative capabilities in the development of radiopharmaceuticals but also positions the company for a significant competitive advantage in the highly competitive oncology market, potentially driving future commercial growth.
See More
