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Radiopharm Theranostics (RADX) posts 93% brain scan match ahead of Phase 3

Filing Impact
(Neutral)
Filing Sentiment
(Neutral)
Form Type
6-K

Rhea-AI Filing Summary

Radiopharm Theranostics Limited reported that it has scheduled an End-of-Phase 2 meeting with the U.S. FDA on October 1, 2026 to discuss the pivotal Phase 3 trial design for RAD101, its Fluorine-18-labeled imaging agent for suspected recurrent brain metastases after radiotherapy. A Phase 2b trial of RAD101 demonstrated 93% concordance between MRI and PET imaging across all evaluable lesions, meeting the study’s primary endpoint and showing substantial, selective tumor uptake. RAD101 has FDA Fast Track Designation for distinguishing recurrent disease from treatment effects in brain metastases from various solid tumors, and Radiopharm has partnered with Siemens Healthineers to manufacture and distribute 18F-RAD101 doses for the planned U.S. Phase 3 registrational trial, with the company indicating it is on track to be Phase 3-ready by year-end 2026.

Positive

  • RAD101 holds FDA Fast Track Designation, supporting an expedited regulatory path for imaging recurrent brain metastases and potentially enhancing the asset’s strategic and commercial value if later-phase trials are successful.
  • Phase 2b RAD101 trial met its primary endpoint with 93% concordance vs MRI, providing supportive efficacy data as the company plans a pivotal Phase 3 program.
  • End-of-Phase 2 FDA meeting set for October 1, 2026 and a supply partnership with Siemens Healthineers position the company operationally for a U.S. Phase 3 registrational trial.

Negative

  • None.
RAD101 Phase 2b concordance 93% concordance with MRI Concordance between MRI and PET imaging across all evaluable lesions in patients with suspected recurrent brain metastases
FDA End-of-Phase 2 meeting date October 1, 2026 Scheduled FDA End-of-Phase 2 meeting to align on pivotal Phase 3 trial design for RAD101
Annual U.S. cerebral metastases cases more than 300,000 patients Patients diagnosed annually with cerebral metastases in the United States
Clinical program scope one Phase 2 and five Phase 1 trials Radiopharm’s clinical program across various solid tumor cancers including lung, breast, and brain metastases
Regulatory designation FDA Fast Track Designation Granted for RAD101 to distinguish recurrent disease from treatment effect in brain metastases from solid tumors
End-of-Phase 2 (EOP2) meeting regulatory
"it has scheduled an End-of-Phase 2 (EOP2) meeting with the U.S. Food"
An end-of-phase 2 (EoP2) meeting is a formal discussion between a drug developer and regulators to review mid-stage clinical results and agree on the design, size and success measures of the pivotal Phase 3 trials needed for approval. For investors, the meeting is like a road-test report with a traffic plan: a favorable outcome reduces uncertainty about whether the program can reach approval, shortens timelines and clarifies likely costs and risks.
Fast Track Designation regulatory
"RAD 101 has received FDA Fast Track Designation to distinguish between"
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 metastases medical
"evaluate RAD101 in patients with suspected recurrence of brain metastases"
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.
Intracranial Metastatic Disease (IMD) medical
"The incidence of Intracranial Metastatic Disease (IMD) continues to increase"
Intracranial metastatic disease (IMD) is cancer that has spread from another part of the body into the brain. For investors, IMD matters because it often requires costly, specialized treatments and can drive demand for new therapies, diagnostics, and medical devices; like a house fire in a distant room, it suddenly changes priorities, timelines and expenses for care and can strongly influence a healthcare company’s revenue and regulatory outlook.
PET-MRI medical
"The study further indicated that PET-MRI may potentially represent a"
PET‑MRI combines two medical scans—one that maps metabolic activity by tracking a tiny injected tracer and one that produces high‑resolution pictures of internal anatomy—into a single exam, like overlaying a heat map on a detailed photograph. Investors care because the technology can improve diagnostic accuracy and treatment planning, influence hospital purchasing and service revenues, and hinge on adoption, cost and insurance reimbursement decisions.

FAQ

What did Radiopharm Theranostics (RADX) announce about its RAD101 program?
Radiopharm Theranostics announced it has scheduled an End-of-Phase 2 FDA meeting on October 1, 2026 to align on a pivotal Phase 3 trial design for RAD101, its Fluorine-18-labeled imaging agent for suspected recurrent brain metastases after radiotherapy.

How did RAD101 perform in the Phase 2b trial reported by RADX?
RAD101’s Phase 2b trial achieved 93% concordance with MRI across all evaluable lesions, meeting the study’s primary endpoint. The data showed substantial and selective tumor uptake with PET imaging, supporting advancement toward a pivotal Phase 3 study.

Does RAD101 have any special FDA status according to Radiopharm Theranostics (RADX)?
RAD101 has received FDA Fast Track Designation to distinguish recurrent disease from treatment effects in brain metastases from various solid tumors, including leptomeningeal disease, indicating regulatory recognition of the unmet medical need it aims to address.

What is the planned next step with the FDA for Radiopharm Theranostics’ RAD101?
Radiopharm has scheduled an End-of-Phase 2 meeting with the FDA for October 1, 2026. The goal is to align on Phase 3 trial design details, including patient numbers and endpoints, as it targets being Phase 3-ready by year-end 2026.

How large is the potential U.S. patient population relevant to RAD101, according to RADX?
Radiopharm cited that in the U.S. there are more than 300,000 patients diagnosed annually with cerebral metastases. This underscores a substantial potential patient pool for improved imaging of recurrent brain metastases if RAD101 ultimately proves successful.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Form 6-K: How Foreign Companies Report to the SEC →

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

Form 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16 UNDER

THE SECURITIES EXCHANGE ACT OF 1934

 

For the Month of August 2026

 

Commission File Number: 001-41621

 

RADIOPHARM THERANOSTICS LIMITED

(Name of Registrant)

 

Level 3, 62 Lygon Street, Carlton South, Victoria, 3053, Australia

(Address of principal executive office)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

 

Form 20-F ☒       Form 40-F ☐

 

 

 

 

 

 

RADIOPHARM THERANOSTICS LIMITED

 

EXPLANATORY NOTE

 

Radiopharm Theranostics Limited (the “Company”) published one announcement (the “Public Notice”) to the Australian Securities Exchange on August 17, 2026 titled:

 

“RAD to meet with US FDA to align on RAD 101 Phase 3 Trial ” 

 

A copy of the Public Notice is attached as an exhibit to this report on Form 6-K.

 

This Form 6-K, including the exhibits hereto, is incorporated by reference into the registration statement of the Company on Form F-3 (File No. 333-292178) and forms part thereof to the extent not superseded by documents or reports subsequently filed by the Company under the Securities Act of 1933 or the Securities Exchange Act of 1934. 

 

1

 

 

EXHIBITS

 

Exhibit
Number		   Description
99.1   RAD to meet with US FDA to align on RAD 101 Phase 3 Trial 

 

2

 

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

  RADIOPHARM THERANOSTICS LIMITED
     
Date: August 17, 2026 By: /s/ Amritha Sushil
    Amritha Sushil
    Company Secretary

 

3

 

Exhibit 99.1

 

ASX ANNOUNCEMENT
17 August 2026

 

Radiopharm Theranostics To Meet with U.S. FDA to Align on Pivotal Phase 3 Trial Design for RAD 101 in Diagnosis of Brain Metastases

 

RAD 101 Phase 2b trial demonstrated 93% concordance with MRI across all evaluable lesions, meeting the Phase 2 trial’s primary endpoint

 

End-of-Phase 2 meeting with the U.S. FDA scheduled for October 1st , 2026; on track to be Phase 3 ready by year-end 2026

 

Sydney, Australia and MALVERN, Pa. – 17 August 2026 – 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 that it has scheduled an End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) for October 1st , 2026, to align on the design of a pivotal Phase 3 trial to evaluate RAD101 in patients with suspected recurrence of brain metastases following radiotherapy. RAD101 is the Company’s novel Fluorine-18-labeled small-molecule imaging agent that targets fatty acid synthase (FASN) and is being developed to diagnose suspected recurrent brain metastases arising from a range of solid tumors.

 

The focus of the meeting will be to align on the pivotal Phase 3 clinical trial design criteria, including the number of patients to be enrolled along with primary and secondary endpoints. The regulators will also be reviewing the data from the Phase 2b trial of RAD 101, which demonstrated 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, with images confirming metabolic activity in PET compared to equivocal MRI findings.

 

“We are pleased to have secured an End-of-Phase 2 meeting with the FDA for RAD101, an important milestone that brings us closer to advancing this promising imaging agent into a pivotal Phase 3 program,” said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. “We believe the upcoming discussion will provide important alignment on the clinical and regulatory pathway forward, enabling us to finalize plans for a registrational study and remain on track to be Phase 3-ready by year-end. Supported by the strong Phase 2b data demonstrating 93% concordance with MRI, we believe RAD101 has the potential to address a meaningful unmet need in the diagnosis of recurrent brain metastases and create significant value for patients, clinicians, and shareholders.”

 

RAD 101 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 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 registrational trial in the U.S.

 

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 Primary tumor. 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 

 

 

1A 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

 

Radiopharm Theranostics Limited
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia
ABN: 57 647 877 889

 

 

 

 

ASX ANNOUNCEMENT
17 August 2026

 

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 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

 

Radiopharm Theranostics Limited
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia
ABN: 57 647 877 889

 

 

 

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