RADX News & Events

Radiopharm Theranostics announced the dosing of the first patient in its First-In-Human, FIH, Phase 1/2a clinical trial of 177Lu-Betabart. The Phase 1/2a clinical trial is a dose escalation and expansion trial of 177Lu-BetaBart, designed to evaluate its safety, biodistribution and radiation dosimetry of 177Lu-BetaBart, along with its preliminary anti-tumor activity. The trial will also determine the recommended dose of 177Lu-BetaBart for future studies. This agent was developed by Radiopharm Ventures, a joint venture between Radiopharm and The University of Texas MD Anderson Cancer Center.

Net cash outflows from operating activities for the 6 months ended December 31, 2025 totaled $22.67M. "2025 was a year of strong execution across our pipeline, as we presented unprecedented imaging data from our RAD 101 diagnostic program, received Data Safety Monitoring Committee approval to escalate dosing in both RAD 204 and RAD 202 programs and secured clearance to advance both RV 01 and RAD 402 into Phase 1 clinical trials," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. "As we enter 2026, we remain laser-focused on advancing our radiopharmaceutical assets and taking a deliberate approach to pipeline prioritization. This year, we aim to deliver meaningful data from across multiple programs, expand treatment and diagnostic options for patients with solid tumors, and create long-term value for all stakeholders."

Radiopharm Theranostics has increased its ownership stake in Radiopharm Ventures, a joint venture created with The University of Texas MD Anderson Cancer Center, from 75% to 87.5%. Radiopharm's decision to increase the ownership percentage comes as the joint venture continues to show promising progress in its cancer therapeutic pipeline, including the advancement of its leading B7H3 candidate and other preclinical assets. B7H3 is an immune checkpoint protein that is very infrequently seen in healthy cells but is consistently overexpressed in the majority of cancer tissues. High expression of B7H3 in cancer is associated with greater tumor size and lymphatic invasion. The lead candidate monoclonal antibody radiolabelled with 177Lu, Betabart, targets B7H3 and successfully received Investigational New Drug clearance in July 2025 by the U.S. Food and Drug Administration. The first patient in this Phase 1 therapeutic trial is expected to be dosed in Q1 2026, with a number of centers already activated. Additionally, two other preclinical candidates have demonstrated early positive results and have progressed towards final candidate selection, with potential applications across multiple solid tumor types.

These names in the biotech sector are seeing a substantial increase in search activity today, as determined by InvestingChannel. They include:Radiopharm, 17,700.84% surge in interestAIM ImmunoTech, 237.37% surge in interestPipeline and key clinical candidates for these companies:Radiopharmis a clinical stage radiotherapeutics company developing a "world-class platform of innovative radiopharmaceutical products" for diagnostic and therapeutic applications in areas of high unmet medical need. Radiopharm is listed on ASX and on NASDAQ. The company has a pipeline of distinct and highly differentiated platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer. The clinical program includes one Phase 2 and four Phase 1 trials in a variety of solid tumor cancers including lung, breast, and brain metastases.AIM ImmunoTechis an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, including COVID-19. The company's lead product is a first-in-class investigational drug called Ampligen, a dsRNA and highly selective TLR3 agonist immuno-modulator with broad spectrum activity in clinical trials for globally important cancers, viral diseases and disorders of the immune system.Recent news on these stocks:December 17Maxim raised the firm's price target on Radiopharm to $15 from $12 and keeps a Buy rating on the shares. The firm cites the company having announced positive results on its primary endpoint in an interim analysis of the first 12 patients in the Phase 2b study of RAD 101, as the study demonstrated concordance with MRI in 92% of patients treated with RAD 101 as a PET imaging agent for brain metastases, the analyst tells investors in a research note. The initial data emerging from the Phase 2b study of RAD 101 in brain metastasis imaging is highly encouraging and de-risks Radopharm's potential to address the $500M market opportunity in brain mets diagnostics and monitoring, the firm added.December 16B. Riley raised the firm's price target on Radiopharm to $16 from $13 and keeps a Buy rating on the shares. Radiopharm reported positive interim Phase 2b imaging data for RAD101 in brain metastases, with 92% MRI concordance and clear, selective tumor uptake consistent with prior Phase 2a results, the analyst tells investors in a research note. Enrollment is over 50% in the 30-patient study, with final data expected in the first half of 2026 to inform Phase 3 design ahead of a planned FDA meeting in mid-2026, B. Riley adds.December 15Radiopharm Theranostics 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 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% of the patients treated with RAD 101 achieved concordance with MRI 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. 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 Fast Track Designation to distinguish between recurrent disease and treatment effect of brain metastases originating from solid tumors of different origin, including leptomeningeal disease.Hear more from InvestingChannel by signing up for.About "Biotech Alert"The Fly will report on a selection of biotech stocks seeing a surge in interest from retail and financial professional investors, based on data from InvestingChannel.This Fly exclusive recap reveals the biotech stocks that are seeing a spike in searches among the 20-plus million retail and financial professional investors through InvestingChannel's online financial news media ecosystem.This increased attention from the investors may be in response to, or advance of, outsized moves for stocks in the biotech sector, which tend to be volatile and prone to sharp swings in share price around binary events such as clinical study results and FDA approvals.