Welcome to our dedicated page for Radiopharm Theranostics news (Ticker: RADX), a resource for investors and traders seeking the latest updates and insights on Radiopharm Theranostics stock.
Radiopharm Theranostics Limited (NASDAQ: RADX, ASX: RAD) generates frequent news flow as a clinical-stage radiotherapeutics company developing radiopharmaceutical diagnostics and therapies for solid tumor cancers. Its announcements cover progress across a pipeline that includes peptides, small molecules and monoclonal antibodies radiolabelled with medical isotopes for oncology applications.
Readers of this page can follow updates on key clinical programs such as 18F‑RAD101, a FASN‑targeting imaging agent in a U.S. Phase 2b trial for suspected or recurrent brain metastases, which has received FDA Fast Track Designation. News also highlights dose‑escalation and safety milestones for 177Lu‑RAD202 in HER2‑positive advanced solid tumors and 177Lu‑RAD204 in PD‑L1‑positive cancers including NSCLC, SCLC, triple‑negative breast cancer, cutaneous melanoma, head and neck squamous cell carcinoma and endometrial cancer.
Company releases provide interim data on tumor uptake, concordance with MRI, safety profiles and recommendations from Data Safety and Monitoring Committees, as well as regulatory events such as IND clearance for RV‑01 (Betabart), a Lu177‑B7H3 monoclonal antibody developed through Radiopharm Ventures with MD Anderson Cancer Center, and ethics approval to initiate the RAD402 prostate cancer trial. Financial and corporate news items include capital raisings, cash flow reports, board changes and strategic supply agreements for radioisotopes like Lutetium‑177 and Terbium‑161.
This news feed aggregates these disclosures so investors and researchers can review clinical trial milestones, regulatory designations, joint venture developments and financing activities related to Radiopharm Theranostics. For ongoing insight into the company’s oncology radiopharmaceutical pipeline, users can monitor this page for new releases and regulatory filings linked to RADX.
Radiopharm Theranostics (NASDAQ:RADX) completed enrollment in its U.S. Phase 2b imaging trial of RAD 101 for recurrent brain metastases, dosing the final patient in a 30-participant study.
Interim data showed 90% concordance with MRI; a primary endpoint readout is expected in June 2026 and the company plans to advance RAD 101 toward a U.S. Phase 3 pivotal trial. RAD 101 has FDA Fast Track designation for distinguishing recurrent disease from treatment effect.
Radiopharm Theranostics (NASDAQ: RADX) received a positive DSMC recommendation to advance 177Lu-RAD202 to 130mCi (Cohort 3) in the Phase 1 HEAT trial for HER2+ advanced solid tumors.
The study is ongoing at Australian sites, the prior dose level was 75mCi (announced 1 Oct 2025), and management says dose escalation remains on track to complete by end of 2026.
Radiopharm Theranostics (ASX:RADX) signed a U.S. supply agreement with Siemens Healthineers to radiolabel and distribute 18F‑RAD101 for upcoming trials. An interim Phase 2b analysis reported 90% concordance (18/20) between RAD101 PET imaging and MRI for brain metastases. The company holds FDA Fast Track designation and expects to start a multi‑center Phase 3 registrational trial in the U.S. after topline Phase 2b readout in H1 2026.
Radiopharm Theranostics (ASX:RADX) has dosed the first patient in the Phase 1 trial of RAD 402, a KLK3-targeting monoclonal antibody radiolabelled with Terbium-161 (Tb161) for advanced prostate cancer. The dose-escalation study will assess safety, whole-body distribution, tolerability and preliminary activity, and determine MTD and/or RP2D.
Preclinical mouse xenografts showed strong tumor targeting, minimal bone/marrow uptake and expected hepatic clearance. The company expects to share data from the first two dose levels in 2H 2026.
Radiopharm Theranostics (ASX:RADX) reported second interim Phase 2b imaging results for RAD 101 in brain metastases on March 24, 2026. Ninety percent (18/20) of dosed, evaluable patients achieved PET–MRI concordance (primary endpoint), with selective tumor uptake and metabolic signal versus equivocal MRI.
First five patients with six‑month follow‑up/biopsy show an encouraging trend for sensitivity and specificity (secondary objectives). FDA Fast Track designation is in place; full 30‑patient readout expected by June 2026. Webinar scheduled March 24–25, 2026.
Radiopharm Theranostics (ASX:RADX) announced dosing of the first patient in its First‑In‑Human Phase 1/2a trial of 177Lu‑BetaBart (RV‑01), the first radiotherapeutic from Radiopharm Ventures, a joint venture with MD Anderson.
The dose‑escalation and expansion study will evaluate safety, biodistribution, radiation dosimetry, preliminary anti‑tumor activity and determine a recommended dose. Preclinical studies showed tumor shrinkage and prolonged survival and support multiple solid‑tumor indications targeting the 4Ig isoform of B7‑H3.
Radiopharm Theranostics (Nasdaq: RADX) reported H1 fiscal 2026 results and pipeline updates highlighting clinical progress and funding. Interim Phase 2b RAD 101 imaging data showed 92% MRI concordance in 12 evaluable patients. Cash and equivalents were $34.52 million, with net operating outflows of $22.67 million.
Key milestones include FDA Fast Track for RAD 101, DSMC dose-escalation clearance for RAD 202 and RAD 204, IND clearance for RV 01, Bellberry ethics approval for RAD 402, and expected cohort data in mid-2026.
Radiopharm Theranostics (NASDAQ: RADX) increased its ownership in Radiopharm Ventures, LLC (a joint venture with MD Anderson) from 75% to 87.5% as the JV advances its oncology radiopharmaceutical pipeline. The lead candidate, Betabart (RV01), a 177Lu-labelled monoclonal antibody targeting B7H3, received FDA IND clearance in July 2025 and is expected to dose its first patient in a Phase I therapeutic study in Q1 2026. Two additional preclinical assets reported early positive results and are moving toward final candidate selection in 2026. The JV combines MD Anderson’s antigen discovery and imaging expertise with Radiopharm’s therapeutic development capabilities.
Radiopharm Theranostics (ASX:RADX) reported interim Phase 2b imaging results for RAD 101 in brain metastases showing 92% concordance (11/12 patients) with MRI and selective tumor uptake on PET imaging.
The company noted 50% trial enrollment, U.S. FDA Fast Track designation for RAD 101, and cited an independent U.S. market opportunity estimate of $500M+ annually. Management plans a webinar on Dec 15–16, 2025 and stated a goal to start a pivotal study by end of 2026.
Radiopharm Theranostics (ASX:RADX) received Bellberry Human Research Ethics Committee approval on November 18, 2025 to start a First‑In‑Human Phase 1 trial of RAD 402, an anti‑KLK3 monoclonal antibody radiolabelled with 161Tb for metastatic or locally advanced prostate cancer.
Preclinical biodistribution in mouse xenografts showed strong tumour targeting, limited bone and marrow uptake, and hepatic excretion. Radiopharm has supply agreements with Terthera (2022) for 161Tb production and Cyclotek (2025) for radiolabelling RAD 402, supporting trial initiation.