Radiopharm Theranostics Announces Alignment with U.S. FDA on Single Pivotal Phase 3 Trial for RAD101 in Diagnosis of Brain Metastases
The planned registrational study would enroll approximately 280 patients with indeterminate brain metastases after radiotherapy.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Radiopharm Theranostics (Nasdaq: RADX) reached FDA alignment on a single pivotal Phase 3 trial evaluating RAD101 for brain metastases after radiotherapy. Final meeting minutes confirm the design for approximately 280 patients with indeterminate brain metastases from various solid tumors. The co-primary endpoints measure sensitivity, the ability to detect disease, and specificity, the ability to exclude it, against a defined reference standard and prespecified performance thresholds.
Phase 2b results showed 93% concordance between MRI and PET imaging in patients with suspected recurrence. RAD101 has FDA Fast Track designation. Siemens Healthineers will manufacture and distribute trial doses in the U.S. The company expects to complete contract research organization selection in fourth quarter 2026, then initiate site activations and begin dosing in first half 2027.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate pointFDA alignment establishes the design for a single pivotal Phase 3 RAD101 imaging trial.
- Moderate pointPhase 2b imaging concordance of 93% was demonstrated between MRI and PET in patients with suspected recurrence.
- Minor pointPhase 2b PET imaging showed selective tumor uptake, including lesions equivocal on MRI.
- Minor pointFDA Fast Track designation covers distinguishing recurrent disease from treatment effects in brain metastases, including leptomeningeal disease.
- Minor point. Forward-looking: it has not happened yet and may not happen.Siemens Healthineers partnership provides manufacturing and distribution of RAD101 doses for the U.S. Phase 3 trial.
- Minor point. Forward-looking: it has not happened yet and may not happen.Trial preparations target research organization selection in fourth quarter 2026 and site activation and dosing in first half 2027.
Negative
- None.
Details
Market Reaction – RADX
On Nov 4, the day this news came out, the latest delayed price for RADX is 1.11% above the previous close. Argus tracked a trough of -38.3% from its starting point during tracking. Our momentum scanner has recorded 12 alerts for this stock so far that day. The latest delayed price is $0.90. Relative volume is very high at 4.3x the stock’s average daily volume.
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Key Figures
- Planned trial enrollment
- approximately 280 patients
- Single pivotal Phase 3 imaging trial
- Phase 2b imaging concordance
- 93%
- RAD101 PET and MRI in patients with suspected recurrence
- CRO selection
- Fourth quarter 2026
- Expected timing for Phase 3 preparations
- Site activations and patient dosing
- First half 2027
- Expected Phase 3 study start activities
Previous Clinical trial Reports
-
End-of-Phase 2 FDA meeting completed; prior Phase 2b results showed 93% concordance with MRI.
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RAD101 met its primary endpoint with 93% concordance between PET and MRI across evaluable lesions.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
co-primary endpoints medical
fatty acid synthase medical
pet medical
fast track designation regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
Single, multicenter Phase 3 imaging trial of approximately 280 patients with brain metastases designed to demonstrate sensitivity and specificity above prespecified performance thresholds
Radiopharm Theranostics advancing preparations for Phase 3 study with clinical supply of 18F-labeled RAD101 from partnership with Siemens Healthineers
Company expects to complete CRO selection in the fourth quarter 2026, initiate site activations and begin dosing patients in first half 2027
SYDNEY, Nov. 04, 2026 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX:RAD, Nasdaq: RADX, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced receipt of the final meeting minutes following its End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA), at which the Company reached alignment with the FDA on the design of a pivotal Phase 3 trial to evaluate RAD101 in patients with indeterminate brain metastases following radiotherapy. The pivotal, multicenter single Phase 3 imaging clinical trial is expected to enroll approximately 280 patients with indeterminate brain metastases from various solid tumor types after previous radiotherapy. The co-primary endpoints of the study will be sensitivity and specificity of RAD101 PET against a defined reference standard.
RAD101 is the Company’s novel imaging small molecule that selectively binds to fatty acid synthase (FASN), a multi-enzyme protein that catalyses de novo fatty acid synthesis and is overexpressed in brain metastases from solid tumors. Targeting FASN activity may allow for the more accurate detection of cancer cells in the CNS, representing a clinically relevant method for the imaging of brain metastases.
Regulators reviewed the data from the Company’s Phase 2b trial of RAD101, which demonstrated
"Accurately distinguishing recurrent tumor from treatment-related necrosis is one of the most important challenges physicians face when managing patients with brain metastases. This determination has profound implications for patient care, helping clinicians decide whether a patient requires additional intervention and treatment or can be managed with continued observation and surveillance. Existing imaging modalities often leave uncertainty, creating difficult clinical decisions for both physicians and patients. RAD101 has shown the potential to resolve diagnostic uncertainty in lesions that are equivocal on MRI, potentially offering a clearer assessment of active disease,” said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. “We are grateful to the FDA for its constructive review of our clinical data and for aligning with us on a single, multicenter pivotal study design. Importantly, the approximately 280-patient trial is substantially smaller than many historical registrational imaging studies (i.e. prostate cancer imaging agents required two Phase 3 trials and more than 700 patients combined.) We believe this reflects the significant unmet medical need faced by patients with brain metastases from solid tumors. We look forward to advancing RAD101 into this pivotal study as we work to provide physicians and patients with a more reliable tool to guide critical treatment decisions."
RAD101 has received FDA Fast Track Designation to distinguish between recurrent disease and treatment effect of brain metastases originating from solid tumors of different origin including leptomeningeal disease. The company has also announced a partnership with Siemens Healthineers, who will manufacture and distribute doses of 18F-labeled RAD101 to support the upcoming Phase 3 registrational trial in the U.S.
In the U.S. alone, there are more than 300,000 patients diagnosed annually with brain metastases. The incidence of Intracranial Metastatic Disease (IMD) continues to increase, in part, due to improvements in systemic therapy resulting in a more durable control of the tumors outside of the central nervous system. Contrast-enhanced Magnetic Resonance Imaging (CE-MRI) is the preferred method for imaging IMD, but has limitations, particularly in follow-up surveillance scans to optimise patient care.1
About RAD101
RAD101 is the Company’s novel imaging small molecule that selectively binds to fatty acid synthase (FASN), a multi-enzyme protein that catalyses de novo fatty acid synthesis and is overexpressed in brain metastases from solid tumors. Targeting FASN activity may allow for the more accurate detection of cancer cells in the CNS, representing a clinically relevant method for the imaging of brain metastases. Positive data from the Imperial College of London’s Phase 2a imaging trial of 18F-RAD101 in patients with brain metastases (both SRS pre-treated and treatment naïve patients) showed significant tumor uptake that was independent from the tumor of origin. The study further indicated that PET-MRI may potentially represent a non-invasive prediction of overall survival, warranting larger studies.
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.
For more information:
Riccardo Canevari
CEO & Managing Director
P: +1 862 309 0293
E: rc@radiopharmtheranostics.com
Anne Marie Fields
Precision AQ (Formerly Stern IR)
E: annemarie.fields@precisionaq.com
Media
Matt Wright
NWR Communications
P: +61 451 896 420
E: matt@nwrcommunications.com.au
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What trial design did Radiopharm Theranostics agree with the FDA for RAD101?
The FDA alignment covers a single multicenter pivotal Phase 3 imaging trial expected to enroll approximately 280 patients with indeterminate brain metastases after radiotherapy. Its co-primary endpoints are sensitivity and specificity of RAD101 PET against a defined reference standard, with prespecified performance thresholds.
When does Radiopharm Theranostics expect to start dosing patients in the RAD101 Phase 3 trial?
Radiopharm expects to begin dosing patients in first half 2027, alongside initiating site activations. The company expects to complete selection of a contract research organization in fourth quarter 2026.