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.
U.S. supply agreement with Siemens Healthineers for 18F manufacturing
Negative
Small Phase 2b cohort with only 20 patients in the concordance analysis
Limited follow‑up data: five patients had evaluable six‑month/biopsy outcomes
Phase 3 start conditional on topline Phase 2b readout in H1 2026
News Market Reaction – RADX
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This announcement advances RAD101 by pairing strong Phase 2b concordance data of 90% (18/20 patients...
Analysis
This announcement advances RAD101 by pairing strong Phase 2b concordance data of 90% (18/20 patients) with a Siemens supply deal for a U.S. Phase 3 registrational trial. It builds on prior Fast Track status and earlier interim readouts. Investors may track timing of the Phase 2b topline data in 1H 2026, initiation of the Phase 3 trial, and any use of the effective F‑3 resale registration for up to 940,000 ADSs.
Key Figures
PET–MRI concordance:90%Concordant patients:18/20 patientsEvaluable follow-up patients:5 patients+4 more
7 metrics
PET–MRI concordance90%Primary endpoint in RAD101 Phase 2b interim analysis
Concordant patients18/20 patientsRAD101 Phase 2b second interim analysis
Evaluable follow-up patients5 patientsSix-month follow-up and/or biopsy data for secondary objectives
Trial phasePhase 2bRAD101 imaging trial in brain metastases
Planned trial phasePhase 3 registrationalUpcoming global trial of RAD101 in the U.S.
Annual U.S. incidence300,000 peopleEstimated yearly diagnoses of brain metastases in the U.S.
Ownership in Radiopharm Ventures increased to 87.5% with advancing pipeline.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Pattern Detected
Clinical and strategic updates have often been positive, but one strong RAD101 readout coincided with a double‑digit drop, indicating occasional negative reactions to good clinical news.
Recent Company History
Over the last six months, Radiopharm reported multiple clinical advances, including dosing first patients in early‑stage trials (RAD 402, RV‑01) and strong interim data for RAD101 with up to 92% MRI concordance. It also increased its stake in Radiopharm Ventures and reported H1 2026 financials with adequate cash. The current Siemens supply agreement for RAD101’s U.S. Phase 3 fits this trajectory of moving assets from promising imaging data into later‑stage, potentially registrational development.
"Data from the interim analysis in Phase 2b trial of RAD101 showed significant..."
Phase 2b is a stage in the development of a new medicine or treatment where researchers test its effectiveness and safety in a larger group of people. This step helps determine whether the treatment works well enough to move forward and if it has manageable side effects, which is important for investors because successful results can lead to potential approval and market opportunity.
phase 3 registrational trialmedical
"Partnership ensures sufficient supply of RAD 101 in Phase 3 registrational trial in the U.S."
A phase 3 registrational trial is a large, late-stage clinical study designed to produce the definitive safety and effectiveness data regulators need to decide whether to approve a new medical product. For investors, its results are critical because positive findings greatly increase the chance of market authorization and future sales, while negative or ambiguous results can sharply reduce expected value—think of it as the product’s final exam before getting a license to sell.
fluorine-18 (18f)medical
"Siemens Healthineers will radiolabel and distribute RAD101 with Fluorine-18 (18F)."
Fluorine-18 (18F) is a short-lived radioactive version of the element fluorine used to tag molecules that show up on PET scans, a common type of medical imaging. Because it decays in roughly two hours, it behaves like a highly perishable ingredient: production, transport and timing are critical, so shortages, production costs or regulatory limits can quickly affect hospitals, drug makers and the revenue streams of companies that supply or use PET imaging agents.
fatty acid synthase (fasn)medical
"RAD101 is Radiopharm’s novel imaging small molecule targeting fatty acid synthase (FASN)..."
Fatty acid synthase (FASN) is an enzyme that acts like a cellular factory, building long-chain fatty acids from smaller molecular pieces for use in cell membranes, energy storage, and signaling. Investors care because FASN activity is linked to metabolic conditions and certain cancers, making it a potential target for drugs or diagnostics; changes in companies’ progress on FASN-related therapies or tests can affect valuations and risk assessment.
pet imagingmedical
"90% (18/20) of the patients dosed with RAD101 achieved concordance between PET imaging and MRI..."
PET imaging is a noninvasive medical scan that works like a molecular camera, using tiny radioactive tracers to reveal biological activity inside the body—for example metabolism, blood flow, or the presence of specific proteins. It matters to investors because PET results guide diagnosis, show whether a drug reaches its intended target and how patients respond, and therefore affect clinical trial success, regulatory approval, reimbursement decisions and demand for scanners, tracers and related services.
fast track designationregulatory
"The company has received U.S. Food and Drug Administration (FDA) Fast Track Designation..."
Fast track designation is a status the U.S. Food and Drug Administration grants to drugs intended to treat serious conditions and address an unmet medical need. It gives the developer more frequent communication with the FDA and can allow parts of the application to be reviewed on a rolling basis, and it may pave the way to priority review or accelerated approval. It can shorten development timelines, though it does not guarantee approval.
brain metastasesmedical
"tumor uptake in brain metastases, with 90% concordance (Primary Endpoint) with MRI."
Cancer cells that have spread from another part of the body to the brain, forming new tumors there. Think of it like weeds from one garden taking root in another; the behavior and treatment needs can change significantly once cancer reaches the brain. For investors, brain metastases matter because they often drive different clinical trial designs, higher healthcare costs, and urgent demand for effective therapies, all of which can materially affect a biotech or healthcare company’s prospects.
leptomeningeal diseasemedical
"including leptomeningeal disease."
Leptomeningeal disease is when cancer cells spread to the thin membranes that cover the brain and spinal cord, disrupting normal function much like mold spreading to the lining of a room. It matters to investors because it signals a severe, hard-to-treat condition that can affect drug development, clinical trial outcomes, regulatory decisions and the market potential for therapies targeting central nervous system involvement.
Data 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 RAD 101 in Phase 3 registrational trial in the U.S.
SYDNEY, April 07, 2026 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, and Siemens Healthineers, today announced the signing of a supply agreement in which Siemens Healthineers will radiolabel and distribute RAD101 with Fluorine-18 (18F). RAD101 is Radiopharm’s novel imaging small molecule targeting fatty acid synthase (FASN) radiolabelled with Fluorine-18 for the diagnosis of suspected recurrent brain metastases from solid tumors of different origins.
“This partnership marks a milestone for Radiopharm, as we bring RAD101 closer to improving diagnostic precision for brain metastases,” said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. “We have made considerable progress advancing RAD101 through the clinic, and the second interim analysis showed 90% (18/20) of the patients dosed with RAD101 achieved concordance between PET imaging and MRI (the primary endpoint). The results showed significant and selective tumor uptake in the brain metastases. Images confirm metabolic activity in brain metastases compared to equivocal MRI findings. In addition, the first five patients with evaluable six-month follow-up and/or biopsy data show a positive trend for sensitivity and specificity (the secondary objectives). This partnership ensures our supply of 18F-labeled RAD101 in the U.S. for the initiation of the multi-center global Phase 3 registrational trial following our readout of topline data in the Phase 2b trial in the first half of 2026.”
The company has received U.S. Food and Drug Administration (FDA) Fast Track Designation to distinguish between recurrent disease and the treatment effect of brain metastases originating from solid tumors of different origins, including leptomeningeal disease.
Under the terms of the agreement, Siemens Healthineers will manufacture and distribute doses of 18F-labeled RAD101 to support Radiopharm’s upcoming Phase 3 registrational trial in the U.S.
“As the leader in PET imaging solutions, we are pleased to partner with Radiopharm Theranostics to provide our reliable and specialized manufacturing capabilities,” said Barry Scott, Head of Radiopharma at Siemens Healthineers. “With our large national network of radiopharmacies in the U.S., we are uniquely qualified and well-equipped to deliver RAD101 as well as other novel PET biomarkers to assist in the fight against challenging diseases such as brain metastases, a condition that more than 300,000 people are diagnosed with in the U.S. each year.”
About Radiopharm Theranostics Radiopharm Theranostics is 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 (RAD) and on NASDAQ (RADX). 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 five Phase 1 trials in a variety of solid tumor cancers including lung, breast, and brain metastases. Learn more at radiopharmtheranostics.com.
Authorised on behalf of the Radiopharm Theranostics board of directors by Chairman Paul Hopper.
What does the Siemens Healthineers supply agreement mean for RADX and RAD101?
It secures U.S. radiolabeling and distribution capacity for 18F‑RAD101. According to the company, Siemens will manufacture and deliver doses via its national radiopharmacy network to support the planned Phase 3 registrational trial.
How strong were RAD101 Phase 2b imaging results reported April 7, 2026 for RADX?
The interim analysis showed 90% concordance between RAD101 PET and MRI. According to the company, 18 of 20 patients met the primary endpoint, with selective tumor uptake observed in brain metastases.
Does RAD101 have regulatory support to accelerate development for RADX?
Yes, RAD101 has FDA Fast Track designation for diagnosing recurrent brain metastases. According to the company, the designation targets distinction between recurrent disease and treatment effect, including leptomeningeal disease.
When will Radiopharm (RADX) start the Phase 3 registrational trial for RAD101?
Phase 3 initiation is planned after the Phase 2b topline readout in H1 2026. According to the company, the Siemens supply agreement ensures 18F availability in the U.S. for the multicenter trial.
How robust are the RAD101 six‑month follow‑up and biopsy results for RADX?
Early follow‑up is limited but shows a positive trend for sensitivity and specificity. According to the company, the first five evaluable patients with six‑month follow‑up and/or biopsy data supported secondary objectives.
