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 (ASX:RAD, Nasdaq:RADX) reported updated preliminary data from the third cohort (90 mCi) of its ongoing first‑in‑human Phase 1 trial of RAD204, a PD‑L1‑targeted lutetium‑177 nanobody radiotherapeutic in advanced solid tumors post‑immunotherapy.
The first patient in cohort 3 achieved a RECIST‑confirmed durable Partial Response, with target lesion reductions of 19% after Dose 1, 43% after Dose 2 (meeting RECIST PR), maintained at 43% after Dose 3 and 35% after Dose 4, remaining progression‑free beyond seven months. The second patient showed an early 7% reduction in target lesions after the first cycle and also remains on treatment and progression‑free. Across dose levels 1–3, no dose‑limiting toxicities have been observed and kidney uptake in Patient 1 was reported as 8.1 Gy over four cycles, which the company said does not preclude escalation to a planned higher dose level. The Phase 1 study aims to determine the recommended Phase 2 dose and characterize safety while assessing preliminary anti‑tumor activity.
Radiopharm Theranostics (ASX:RAD, NASDAQ:RADX) reported positive Phase 2b results for RAD101, an F‑18 PET imaging agent targeting FASN for diagnosing suspected recurrent brain metastases after stereotactic radiosurgery. In 30 evaluable patients, RAD101 PET showed 93% concordance with contrast-enhanced MRI across all assessed lesions, meeting the trial’s primary endpoint.
Among 14 patients with six‑month follow-up and/or biopsy, preliminary sensitivity was 86% (12/14), a secondary objective; specificity data are expected in Q4 2026. Radiopharm plans to initiate a U.S. Phase 3 pivotal trial in Q4 2026, supported by an existing FDA Fast Track Designation and a U.S. manufacturing and distribution partnership with Siemens Healthineers for 18F‑RAD101. The company estimates a ~$600+ million total addressable market for imaging brain metastases, for which it notes there is currently no approved PET product.
Radiopharm Theranostics (Nasdaq: RADX) provided a business update on April 23, 2026, reporting clinical and financial progress. Key clinical milestones include completed enrolment in the Phase 2b RAD 101 imaging trial (final patient dosed), Phase 0/1 RAD 202 data showing tumor uptake and no dose‑limiting toxicities, and initiation of two FIH therapeutic trials (RV‑01, RAD 402). Cash at quarter end was $19.2M, down from $34.5M, with net operating cash outflows of $14.9M.
Radiopharm Theranostics (Nasdaq: RADX) reported initial Phase 0/1 HEAT trial findings for 177Lu-RAD202 on April 20, 2026. In three patients dosed at 30 mCi, the agent showed meaningful tumor uptake, mainly in breast lesions, was generally well tolerated (predominantly Grade 1–2 AEs), and had no dose-limiting toxicities.
The Data Safety and Monitoring Committee approved escalation to the third cohort at 130 mCi; organ dosimetry remained within expected, clinically acceptable ranges.
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.