Radiopharm Theranostics Announces Positive Phase 2b Trial Results of RAD 101 for Diagnosis of Brain Metastases

Rhea-AI Summary

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.

Positive

• 93% PET–MRI concordance achieved primary endpoint in 30 evaluable patients
• Preliminary 86% sensitivity based on 14 patients with 6‑month follow‑up/biopsy
• Plan to start U.S. Phase 3 pivotal trial for RAD101 in Q4 2026
• RAD101 holds FDA Fast Track Designation for distinguishing recurrence vs treatment effect

Negative

• Phase 2b trial sample size limited to 30 evaluable patients
• Sensitivity estimate based on only 14 patients with follow‑up/biopsy data
• RAD101 specificity data not yet available, expected in Q4 2026

Market Context

RADX previously declined 2.48% after an April business update, showing that favorable development ne...

Analysis

RADX previously declined 2.48% after an April business update, showing that favorable development news has not produced uniform historical alignment. The active F-3 is a resale registration, and low short positioning are relevant risk factors to watch.

Key Figures

MRI-PET concordance: 93% Follow-up patients: 14 patients Sensitivity: 86% (12/14) +5 more

8 metrics

MRI-PET concordance 93% Phase 2b primary endpoint across all evaluable lesions

Follow-up patients 14 patients Six-month follow-up and/or biopsy data

Sensitivity 86% (12/14) Preliminary secondary objective

Specificity availability Q4 2026 Specificity data expected

Phase 3 timing Q4 2026 Planned U.S. pivotal trial

Addressable market ~$600+m Brain metastases imaging total addressable market

Evaluable participants 30 U.S. Phase 2b RAD101 clinical trial

U.S. annual cerebral metastases diagnoses more than 300,000 patients Annual U.S. diagnoses

Historical Context

5 past events · Latest: Apr 23 (Negative)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Apr 23	Business update	Negative	-2.5%	Clinical progress accompanied by lower cash and reported operating outflows.
Apr 20	Phase 1 data	Positive	+4.6%	RAD202 showed tumor uptake, tolerability, and no dose-limiting toxicities.
Apr 16	Phase 2b enrollment	Positive	-0.2%	Enrollment completed with interim 90% concordance and planned Phase 3 advancement.
Apr 08	Phase 1 escalation	Positive	+3.0%	DSMC recommended advancing RAD202 to the 130mCi third cohort.
Apr 07	Supply agreement	Positive	-1.6%	Siemens agreement supported U.S. RAD101 supply for planned Phase 3 trials.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Positive clinical and partnership announcements produced mixed historical reactions, with gains on some trial updates but declines on RAD101-related and business updates.

Key Terms

fasn, fluorine-18, phase 2b, phase 3 pivotal trial, +1 more

5 terms

fasn medical

"targeting fatty acid synthase (FASN) radiolabelled with Fluorine-18"

FASN (fatty acid synthase) is a cellular enzyme that builds long-chain fatty acids, important building blocks for cell membranes and energy storage. Investors watch FASN because high activity or abnormal levels can signal disease processes or serve as a drug target, so changes in research results, clinical trials or diagnostic use can affect the value of companies developing therapies or tests—think of it as a factory machine whose output influences the health and prospects of a business.

fluorine-18 medical

"radiolabelled with Fluorine-18 for the diagnosis"

A radioactive isotope of fluorine used as a tracer in medical imaging, especially positron emission tomography (PET). It emits positrons and has a short half-life (about 110 minutes), so it must be produced near where it is used and delivered quickly—like a perishable ingredient for a lab-made diagnostic test. Investors care because its production, supply chain, and approval drive demand for imaging services, radiopharmaceutical manufacturers, and related healthcare infrastructure.

phase 2b medical

"Positive data from all thirty evaluable patients in the Phase 2b trial"

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 pivotal trial medical

"advance RAD101 into a U.S. Phase 3 pivotal trial"

A phase 3 pivotal trial is the large, final clinical study that tests whether a new drug or medical treatment works and is safe enough for regulators to approve it for widespread use. Think of it as the full-scale dress rehearsal before a product launches: positive results can unlock regulatory approval and big commercial upside, while failures can halt a program and significantly affect investor value.

fast track designation regulatory

"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.

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RAD101 PET demonstrated 93% concordance with MRI across all evaluable lesions, meeting the trial's primary endpoint.

14 patients with available data from six-month follow-up and biopsy show preliminary 86% (12/14) Sensitivity (secondary objective). Specificity data will be available in Q4 2026.

The Company plans to advance RAD101 into a U.S. Phase 3 pivotal trial in Q4 2026

The imaging Brain Metastases total addressable market is ~$600+m for which there is no currently approved PET product

SYDNEY, July 22, 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, today announced positive data from all thirty evaluable patients in the Phase 2b trial of RAD101 in participants with suspected recurrence of brain metastases after radiotherapy. 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. The data from these findings will be used to support the initiation of a pivotal multi-center, global Phase 3 imaging trial.

The analysis of the imaging data for all assessed lesions showed 93% concordance between MRI and PET imaging of brain metastases in this patient population with suspected recurrence. The results showed substantial and selective tumor uptake of RAD101. Images confirm metabolic activity in PET compared to equivocal MRI findings.

Additionally, 14 patients with evaluable six-month follow-up and/or biopsy data show preliminary 86% sensitivity, representing a strong positive trend (a secondary objective). Sensitivity measures an imaging test's ability to correctly identify patients with disease.

“The entirety of this dataset captures the strength and potential of RAD101 to address a difficult diagnostic challenge in neuro-oncology,” said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. “Achieving the primary endpoint provides strong validation of our approach and supports the advancement of RAD101 into an intended registrational Phase 3 program. We look forward to continuing our discussions with the U.S. FDA as we finalize the study design and work toward bringing a more precise diagnostic tool to patients and clinicians. With this positive data in hand, we have a strong foundation from which to launch our pivotal trial.”

In the U.S. alone, there are more than 300,000 patients diagnosed annually with cerebral 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 

RAD101 has received U.S. Food and Drug Administration (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 also recently announced a partnership with Siemens Healthineers, who will manufacture and distribute doses of 18F-labeled RAD101 to support Radiopharm’s upcoming Phase 3 pivotal trial in the U.S.

About the Phase 2b Clinical Trial of RAD101

The U.S. multicenter, open-label, single arm Phase 2b clinical trial is assessing the diagnostic
performance of 18F-RAD101 in 30 evaluable individuals with suspected recurrent brain metastases from solid tumors of different origins. The primary objective of the study is concordance between 18F-RAD101 PET-positive lesions and those equivocal lesions seen in conventional imaging (MRI with gadolinium) in participants with known brain metastases and suspected relapse after stereotactic radiosurgery (SRS). Secondary endpoints are sensitivity and specificity of RAD101 in identifying tumor recurrence versus radiation-associated changes in previously SRS-treated brain metastases.

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 cerebral metastasis 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 2b 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

^{____________________________________
1} A hybrid [18F]fluoropivalate PET-multiparametric MRI to detect and characterise brain tumour metastases based on a permissive environment for monocarboxylate transport | European Journal of Nuclear Medicine and Molecular Imaging

FAQ

What did Radiopharm Theranostics (RADX) report from the Phase 2b trial of RAD101 for brain metastases?

Radiopharm reported that RAD101 PET reached 93% concordance with contrast-enhanced MRI in 30 evaluable patients, meeting the primary endpoint. According to Radiopharm, preliminary sensitivity was 86% (12/14) in patients with six‑month follow-up or biopsy data, a key secondary objective supporting further development.

How accurate was RAD101 compared with MRI in Radiopharm Theranostics’ (RADX) Phase 2b brain metastases study?

RAD101 PET imaging showed 93% concordance with MRI across all assessed lesions in the Phase 2b trial. According to Radiopharm, images demonstrated substantial and selective tumor uptake and confirmed metabolic activity on PET where MRI findings were equivocal, addressing a challenging neuro-oncology diagnostic scenario.

What are the next steps for RAD101 after the positive Phase 2b results announced by Radiopharm Theranostics (RADX)?

Radiopharm plans to advance RAD101 into a U.S. Phase 3 pivotal trial starting in Q4 2026. According to Radiopharm, data from this Phase 2b study will support the global multicenter Phase 3 imaging trial, aided by its FDA Fast Track Designation and Siemens Healthineers supply partnership.

What is the market opportunity for RAD101 in imaging brain metastases according to Radiopharm Theranostics (RADX)?

Radiopharm estimates the total addressable market for imaging brain metastases at approximately $600+ million. According to Radiopharm, there is currently no approved PET product for this indication, positioning RAD101 as a potential entrant if later-stage trials and regulatory reviews are successful.

What regulatory advantages does RAD101 have in the U.S., and how might this affect Radiopharm Theranostics (RADX)?

RAD101 has received U.S. FDA Fast Track Designation for distinguishing recurrent disease from treatment effect in brain metastases. According to Radiopharm, this status is intended to facilitate development and review, potentially streamlining interactions with the FDA during planned Phase 3 and registration activities.

How will Siemens Healthineers support the Phase 3 trial of RAD101 for Radiopharm Theranostics (RADX)?

Siemens Healthineers will manufacture and distribute 18F-RAD101 doses in the U.S. for the upcoming Phase 3 trial. According to Radiopharm, this partnership is designed to secure reliable radiotracer supply across trial sites, supporting execution of the pivotal global imaging study in brain metastases.

When will full sensitivity and specificity data for RAD101 be available for Radiopharm Theranostics (RADX) investors?

Preliminary sensitivity of 86% (12/14) has been reported from patients with follow‑up or biopsy. According to Radiopharm, additional specificity data are expected in Q4 2026, which will further characterize RAD101’s ability to differentiate tumor recurrence from radiation-associated changes.