$RADX News

Last published 1w ago

1w agoRADXRadiopharm Theranostics Announces Alignment with U.S. FDA on Single Pivotal Phase 3 Trial for RAD101 in Diagnosis of Brain MetastasesGlobeNewswireSingle, multicenter Phase 3 imaging trial of approximately 280 patients with brain metastases designed to demonstrate sensitivity and specificity above prespecified performance thresholds Radiopharm Theranostics
1w agoRADXRadiopharm Theranostics Reports Business UpdateGlobeNewswirePhase 3 imaging trial of RAD101 in recurrent brain metastases from solid tumors expected to initiate in 1Q27 following successful end-of-phase 2 meeting with U.S. Food and Drug Administration Reported positive Phase
1mo agoRADXRadiopharm Theranostics Selected for Late-Breaking Oral Presentation of Positive Data from Interim Analysis of U.S. Phase 2b Imaging Trial of RAD101 at 2026 Society of Neuro-Oncology Annual MeetingGlobeNewswireRAD101 PET demonstrated 93% concordance with MRI across all evaluable lesions, meeting the trial's primary endpoint Meeting with FDA planned on October 1st to align on RAD101Phase 3 pivotal trial protocol Brain
2mo agoRADXRadiopharm Theranostics Announces Positive Data from the Phase 1 Imaging Trial of RAD301 in Patients with Pancreatic Ductal AdenocarcinomaGlobeNewswirePositive safety and favourable biodistribution seen in all subjects dosed Imaging data in all evaluable pancreatic cancer patients demonstrated significant tumor uptake Data support the targeting potential
2mo agoRADXRadiopharm Theranostics Doses First Patient in Second Cohort of Phase 1/2a Clinical Trial of BetaBart (RV-01) in B7-H3 Expressing Solid TumorsGlobeNewswireSYDNEY, Aug. 26, 2026 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX: RAD, NASDAQ:RADX, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative
2mo agoRADXRadiopharm Theranostics Receives Positive Recommendation from Data Safety and Monitoring Committee to Advance to Cohort 4 in 177Lu-RAD202 Phase 1 HEAT Clinical TrialGlobeNewswireAdvancing RAD202 Phase 1 trial to next dose level of 180mCi in patients with HER2+ advanced solid tumors Previous diagnostic study of RAD202 in ten HER2-positive breast cancer patients demonstrated clinical
2mo agoRADXRadiopharm Theranostics To Meet with U.S. FDA to Align on Pivotal Phase 3 Trial Design for RAD 101 in Diagnosis of Brain MetastasesGlobeNewswireRAD 101 Phase 2b trial demonstrated 93% concordance with MRI across all evaluable lesions, meeting the Phase 2 trial's primary endpoint End-of-Phase 2 meeting with the U.S. FDA scheduled for October 1st , 2026;
3mo agoRADXRadiopharm Theranostics Reports Business UpdateGlobeNewswireReported positive results from the Phase 2b clinical trial of imaging agent RAD 101, showing 93% of evaluable patients treated with RAD 101 achieved the primary endpoint Plans to initiate Phase 3 registrational trial
3mo agoRADXRadiopharm Theranostics Announces Concurrent US$4.1 Million Registered Direct Offering and Up To Additional A$12.7 (US$8.9) Million Australian Placement and Share Purchase PlanGlobeNewswireNEW YORK and SYDNEY, July 24, 2026 (GLOBE NEWSWIRE) -- Radiopharm Theranostics Limited (ASX: RAD, NASDAQ:RADX, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on
3mo agoRADXRadiopharm Theranostics Achieves Confirmed Durable Partial Response in Ongoing Phase 1 Trial of RAD204 in Patients with Advanced Solid Tumors Post-ImmunotherapyGlobeNewswireFirst RECIST-confirmed durable Partial Response at current highest dose level #3 (90mCi) with the patient remaining progression free beyond seven months Second patient dosed remains progression free on treatment with
3mo agoRADXRadiopharm Theranostics Announces Positive Phase 2b Trial Results of RAD 101 for Diagnosis of Brain MetastasesGlobeNewswireRAD101 PET demonstrated 93% concordance with MRI across all evaluable lesions, meeting the trial's primary endpoint. 14 patients with available data from six-month follow-up and biopsy show preliminary 86% (12/14)
6mo agoGTBP IDYA RADX SMMTA Cancer Antigen Long Thought Untouchable Is Suddenly the Hottest Target in OncologyGlobeNewswireIssued on behalf of GT Biopharma, Inc. From bispecific ADCs at IDEAYA to a GSK partnership at Summit, B7-H3 has become one of the most actively pursued antigens in solid tumor oncology — and a new natural killer cell
6mo agoRADXRadiopharm Theranostics Reports Business UpdateGlobeNewswireCompleted enrolment in Phase 2b clinical trial of imaging agent RAD 101 in patients with recurrent brain metastases following earlier announcement of interim data demonstrating concordance with MRI (the primary endpoint)
6mo agoRADXRadiopharm Theranostics Presents Initial Findings from Phase 1 First-in-Human HEAT Clinical Trial for 177Lu-RAD202 in HER2+ Solid Tumors at American Association for Cancer Research 2026GlobeNewswire177Lu-RAD202 demonstrated encouraging tumor uptake and a favorable safety profile in the lowest dose cohort Data Safety and Monitoring Committee Recently Approved Advancing 177Lu-RAD202 to Next Highest Dose at 130 mCi
6mo agoRADXRadiopharm Theranostics Completes Enrollment in U.S. Phase 2b Imaging Trial of RAD 101 for Diagnosis of Brain MetastasesGlobeNewswireInterim data to date showed 90% concordance with MRI (the primary endpoint) Clinical trial readout (Primary endpoint) expected in June 2026 Plans to advance RAD 101 into U.S. Phase 3 pivotal trial SYDNEY, April 16,
7mo agoRADXRadiopharm Theranostics Advances to Cohort 3 in 177Lu-RAD202 Phase 1 Dose Escalating Clinical TrialGlobeNewswireSYDNEY, April 08, 2026 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX: RAD, NASDAQ:RADX, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative oncology
7mo agoRADXRadiopharm Theranostics and Siemens Healthineers Sign Clinical Supply Agreement for RAD101 in the U.S.GlobeNewswireData from the interim analysis in Phase 2b trial of RAD101 showed significant and selective tumor uptake in brain metastases, with 90% concordance (Primary Endpoint) with MRI. Partnership ensures sufficient supply of
7mo agoRADXRadiopharm Theranostics Doses First Patient in Phase 1 Clinical Study of RAD 402 in Advanced Prostate CancerGlobeNewswireOn track to share data from first two dose levels in 2H 2026 Targeting KLK3 and leveraging the dual emission of Tb161 represents an innovative approach for radiotherapies in Prostate Cancer Preclinical proof-of-concept
7mo agoRADXRadiopharm Theranostics Achieves Primary Endpoint In 90% of Patients At Second Interim Analysis of RAD 101 Phase 2b Imaging Trial in Brain MetastasesGlobeNewswire90% of patients dosed with RAD 101 and evaluable at interim analysis achieved concordance with MRI imaging (the primary endpoint) First five patients with available data from six-month follow-up and biopsy show
8mo agoRADXRadiopharm Theranostics Doses First Patient in Phase 1/2a Clinical Study of BetaBart (RV-01)GlobeNewswireFirst radiotherapeutic agent developed by Radiopharm Ventures, the joint venture between Radiopharm Theranostics and MD Anderson Cancer Center Preclinical animal studies of BetaBart (RV-01) have demonstrated tumor
9mo agoRADXRadiopharm Theranostics Reports Half-Year Financial Results and Business UpdatesGlobeNewswireInterim 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
9mo agoCBBHF CEIEF CLNN COPAF+26Presenting on Emerging Growth Conference 89 Day 1 on January 21; Register to live streamGlobeNewswireMIAMI, Jan. 20, 2026 (GLOBE NEWSWIRE) -- EmergingGrowth.com a leading independent small cap media portal announces the schedule of the 89th Emerging Growth Conference on January 21 & 22, 2026. The Emerging Growth
10mo agoRADXRAD Increases Ownership in Radiopharm Ventures to 87.5%GlobeNewswireRadiopharm Ventures, LLC, is a joint venture created in 2022 between MD Anderson Cancer Center and Radiopharm TheranosticsLeading candidate Betabart, a monoclonal antibody targeting B7H3, has received FDA IND clearance
11mo agoRADXRadiopharm Theranostics Achieves Primary Endpoint in 92% of Patients at Interim Analysis of RAD 101 Phase 2b Imaging Trial in Brain MetastasesGlobeNewswire92% of evaluable patients at interim analysis treated with RAD 101 achieved concordance¹ with MRI imaging (the primary endpoint) with significant and selective tumor uptake in suspected or recurrent brain metastases
11mo agoRADXRadiopharm Theranostics Receives Approval to Initiate Phase 1 Therapeutic Trial of RAD 402 (KLK3-mAb with Tb161) in Advanced Prostate CancerGlobeNewswireRAD 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
11mo agoRADXRadiopharm Theranostics Announces 50% Enrollment in Phase 2b Clinical Trial of RAD101 Imaging in Brain MetastasesGlobeNewswireEarly 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
12mo agoRADXRadiopharm Theranostics starts enrollment of the Third Cohort of Phase 1 Dose Escalation Clinical Trial of 177Lu-RAD204GlobeNewswireData 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
1y agoRADXRadiopharm Theranostics Provides Positive Clinical Updates Across Four ProgramsGlobeNewswirePreliminary data from first three patients in Phase 2b imaging clinical trial of RAD 101 show uptake in brain metastases from solid tumors, confirming proof-of-concept with Phase 2 topline results expected by H1
1y agoRADXRadiopharm Theranostics completes A$35 million Placement and launches a A$5 million Share Purchase PlanGlobeNewswireRAD has received firm commitments for a A$35 million capital raising via an institutional private placement to new Australian and international institutional and sophisticated investors at A$0.03 per ordinary
1y agoRADXRadiopharm Theranostics Receives Positive Recommendation from Data Safety and Monitoring Committee (DSMC) to Accelerate 177Lu-RAD202 Phase 1 'HEAT' Dose Escalation Clinical TrialGlobeNewswireSYDNEY, Oct. 01, 2025 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX: RAD, NASDAQ:RADX, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative oncology
1y agoRADXRadiopharm Theranostics reports Fiscal Year 2025 Financial Results and Business UpdateGlobeNewswireOn track to complete enrollment of first two cohorts of RAD204 following positive recommendation from DSMC to escalate dose to 60mCi of Lu177 On track to complete enrollment of the first cohort of Phase 1 ‘HEAT' trial
1y agoRADXRadiopharm Theranostics Receives IND approval from US FDA to Initiate Phase I Therapeutic Clinical Study to target B7H3 with Betabart (RV-01)GlobeNewswireLu177-B7H3 monoclonal antibody is first in class targeted radiopharmaceutical in development against the 4lg subtype of B7-H3 On track to initiate first-in-human study of RV-01 in solid tumors in 4Q25 SYDNEY, July
1y agoRADXDr Oliver Sartor Appointed to Radiopharm Scientific Advisory BoardGlobeNewswireSYDNEY, July 22, 2025 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX:RAD, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for
1y agoRADXRadiopharm Theranostics and Cyclotek Sign Clinical Supply Agreement for ¹⁶¹Tb-KLK3-mAb Phase I Clinical Trial in AustraliaGlobeNewswireRAD 402 preclinical data package complete; demonstrates safety and promising biodistribution profile Ethics approval and Phase 1 clinical trial start in prostate cancer anticipated in 2H 2025 SYDNEY and
1y agoRADXRadiopharm Theranostics Granted U.S. Food and Drug Administration Fast Track Designation for RAD101 Imaging in Brain MetastasesGlobeNewswireSYDNEY, June 11, 2025 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX:RAD, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for
1y agoRADXRadiopharm Theranostics Doses First Patient in Phase 1 'HEAT' Trial of 177Lu-RAD202 for Treatment of Advanced HER2-Positive Solid TumorsGlobeNewswirePhase 11 First-In-Human study designed to assess safety, tolerability, right dose for Phase 2 and early signs of efficacy of 177Lu-RAD202 in individuals with advanced HER2-positive solid tumors Previous clinical
1y agoRADXRadiopharm Theranostics Reports Preclinical Lu177-B7H3-mAb Data Demonstrating Favourable Biodistribution and High Tumour UptakeGlobeNewswireSupports plans to advance the RV01 program to first-in-human therapeutic basket study in solid tumour cancers Data completes preclinical package for Investigational New Drug submission in mid-2025 with Phase 1
1y agoRADXITM and Radiopharm Sign Supply Agreement for n.c.a. Lutetium-177GlobeNewswireGARCHING / MUNICH, Germany and SYDNEY, May 19, 2025 (GLOBE NEWSWIRE) -- ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, and Radiopharm Theranostics ((ASX:RAD, NASDAQ:RADX), a
1y agoRADXRadiopharm Theranostics Accelerates 177Lu-RAD204 Phase 1 Dose Escalation Clinical Trial Based on Positive Recommendation from Data Safety and Monitoring Committee (DSMC)GlobeNewswireDSMC concluded that Phase 1 study may continue as planned without any modifications On track to complete the enrollment of the first two cohorts by mid-2025 SYDNEY, May 12, 2025 (GLOBE NEWSWIRE) -- Radiopharm
1y agoRADXRadiopharm Theranostics to Participate in the D. Boral Capital Inaugural Global ConferenceGlobeNewswireSYDNEY, May 07, 2025 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX:RAD, NASDAQ:RADX, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative oncology
1y agoRADXRadiopharm Theranostics Doses First Patient with 18F-RAD101 in U.S. Phase 2b Imaging Study of Brain MetastasisGlobeNewswirePhase 2b study evaluating diagnostic performance of 18F-RAD101 for suspected recurrent brain metastases from solid tumors of different origins Underscores Radiopharm's commitment to developing transformative oncology
1y agoRADXNew RAD202 Data Confirms Positive Tumor Uptake and Favorable BiodistributionGlobeNewswireData presented at European Molecular Imaging Meeting (EMIM 2025) for imaging with 68Ga-RAD202 confirms specific accumulation in the tumor, favorable biodistribution and low uptake in non-target organs, except for the
1y agoRADXNew Clinical Trial Data Highlights RAD 101 (18F-Pivalate) Successfully Detects Brain MetastasesGlobeNewswireSuccessful detection of brain metastases using RAD 101 (18F-Pivalate) in a novel multiparametric imaging methodology (PET-mpMRI) study across 22 patients.All brain metastases, regardless of whether they were previously
1y agoRADXLantheus Increases to 12.16% shareholding in Radiopharm with US$5m (A$8m) PlacementGlobeNewswirePrivate placement to radiopharmaceutical industry leader Lantheus, for US$5.0 millionPlacement at A$0.060 per share, representing a premium of 150% to the last closing price of A$0.024Lantheus shareholding in Radiopharm
1y agoRADXRadiopharm Announces Strategic Co-Development Partnership with Lantheus for AustraliaGlobeNewswireRAD to advance the clinical development of Lantheus innovative radiopharmaceuticals in Australia Initial collaboration will focus on a Phase 1 imaging trialFinancial incentives to be paid to RAD upon meeting clinical
1y agoRADXRAD 202 Receives Approval to Start Phase 1 Therapeutic TrialGlobeNewswireEthics approval received in Australia for the initiation of RAD's Phase 1 therapeutic trial of 177Lu-RAD202 in Breast and Gastric CancersThe Phase 1 First-In-Human study is designed to assess the safety, tolerability
1y agoRADXRadiopharm Achieves Nasdaq Listing of American Depositary SharesGlobeNewswireTrading under ticker symbol RADXComplements existing US shareholders (currently holding 21% of Radiopharm)No associated capital raisingModest admin & financial compliance overheads SYDNEY, Nov. 27, 2024 (GLOBE