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

Rhea-AI Summary

Radiopharm Theranostics (ASX:RAD, Nasdaq:RADX) has scheduled an End-of-Phase 2 meeting with the U.S. FDA on October 1, 2026 to align on the design of a pivotal Phase 3 trial of RAD101 in patients with suspected recurrent brain metastases following radiotherapy.

According to the company, its Phase 2b trial of RAD101 showed 93% concordance between MRI and PET imaging across evaluable lesions, meeting the primary endpoint and demonstrating substantial, selective tumor uptake. RAD101 has FDA Fast Track Designation, and a partnership with Siemens Healthineers will supply 18F-labeled RAD101 for the planned U.S. Phase 3 registrational trial, which Radiopharm aims to have Phase 3-ready by year-end 2026.

Positive

• End-of-Phase 2 FDA meeting for RAD101 scheduled on October 1, 2026 to discuss pivotal Phase 3 design
• Phase 2b trial of RAD101 achieved 93% concordance between MRI and PET imaging across all evaluable lesions
• FDA Fast Track Designation granted to RAD101 for distinguishing recurrent brain metastases from treatment effect
• Partnership with Siemens Healthineers to manufacture and distribute 18F-RAD101 doses for the planned U.S. Phase 3 registrational trial
• Company guidance to be Phase 3-ready by year-end 2026 for RAD101 in recurrent brain metastases

Negative

• None.

News Explained

The FDA meeting is scheduled, while Phase 3 enrollment and endpoints remain to be aligned; Radiopharm targets Phase 3 readiness by year-end 2026.

Radiopharm Theranostics has scheduled an End-of-Phase 2 meeting with the U.S. FDA for October 1, 2026 to discuss a pivotal Phase 3 trial for RAD101; the program remains in design alignment, with enrollment and endpoints not yet finalized.

RAD101 is described as a Fluorine-18-labeled imaging molecule that targets fatty acid synthase, while the meeting will review the proposed trial criteria and Phase 2b results.

The Phase 2b trial reported 93% concordance between MRI and PET imaging across evaluable lesions, giving the FDA discussion a stated clinical-data basis without itself establishing the Phase 3 design.

The named milestones are the October 1, 2026 FDA meeting and the company’s target of being Phase 3-ready by year-end 2026; the release does not state that the pivotal trial has begun.

Market Context

Tag-specific clinical-trial history averaged -0.28% across five events, despite mostly positive indi...

Analysis

Tag-specific clinical-trial history averaged -0.28% across five events, despite mostly positive individual outcomes. This FDA meeting sits within a mixed record; the active F-3 is a resale registration, and trial execution remains a risk to monitor.

Key Figures

MRI concordance: 93% FDA meeting date: October 1, 2026 Phase 3 readiness: Year-end 2026 +1 more

4 metrics

MRI concordance 93% RAD101 Phase 2b trial across all evaluable lesions

FDA meeting date October 1, 2026 End-of-Phase 2 meeting

Phase 3 readiness Year-end 2026 Company target for RAD101

Annual cerebral metastases diagnoses More than 300,000 patients United States alone

Previous Clinical trial Reports

5 past events · Latest: Apr 20 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Apr 20	Phase 1 clinical data	Positive	+4.6%	Initial HEAT findings showed tumor uptake and no dose-limiting toxicities.
Apr 08	Phase 1 dose escalation	Positive	+3.0%	DSMC recommended advancing RAD202 to the 130mCi third cohort.
Mar 27	Phase 1 trial dosing	Positive	+0.0%	The company dosed the first patient in the RAD402 study.
Mar 24	Phase 2b imaging data	Positive	-10.8%	Interim results showed 90% PET-MRI concordance in evaluable patients.
Feb 24	Phase 1/2a trial dosing	Positive	+1.8%	The first patient received dosing in the BetaBart clinical trial.

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

Pattern Detected

Tag-specific clinical-trial news produced mostly aligned positive reactions, but one positive RAD101 data announcement diverged with a negative reaction.

Key Terms

fasn, fast track designation, pet-mri, ce-mri, +1 more

5 terms

fasn medical

"targets fatty acid synthase (FASN)"

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.

fast track designation regulatory

"has received 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.

pet-mri technical

"PET-MRI may potentially represent a non-invasive prediction"

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.

ce-mri medical

"Contrast-enhanced Magnetic Resonance Imaging (CE-MRI)"

Contrast-enhanced magnetic resonance imaging (CE-MRI) is an MRI scan performed after a patient receives an injected contrast agent that makes blood vessels, inflammation, tumors, and tissue differences show up more clearly on images. Investors care because CE-MRI is a common diagnostic tool and imaging endpoint in clinical trials, shaping regulatory decisions, hospital equipment purchases, and the market for contrast agents and imaging services—like turning on a spotlight to reveal details that affect clinical and commercial outcomes.

intracranial metastatic disease medical

"The incidence of Intracranial Metastatic Disease (IMD)"

Cancer that has spread from another part of the body to the brain or its surrounding tissues, creating new tumor growths inside the skull. It matters to investors because these cases drive demand for specialized treatments, surgeries, imaging and long‑term care, and can influence clinical trial priorities, regulatory decisions and healthcare spending—think of it like a factory’s control room being disrupted, creating urgent needs for new tools and services.

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

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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 1^st , 2026; on track to be Phase 3 ready by year-end 2026

SYDNEY and MALVERN, Pa., Aug. 17, 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 that it has scheduled an End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) for October 1^st , 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 

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

^{_______________________________________________________
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 (Nasdaq: RADX) announce about its FDA meeting for RAD101 on October 1, 2026?

Radiopharm Theranostics scheduled an End-of-Phase 2 meeting with the U.S. FDA for October 1, 2026. According to the company, the goal is to align on pivotal Phase 3 trial design for RAD101 in suspected recurrent brain metastases after radiotherapy, including endpoints and patient numbers.

What were the key Phase 2b trial results for RAD101 in diagnosing brain metastases for Radiopharm Theranostics (RADX)?

The RAD101 Phase 2b trial demonstrated 93% concordance with MRI across all evaluable lesions. According to Radiopharm Theranostics, the study met its primary endpoint and showed substantial, selective tumor uptake on PET, confirming metabolic activity where MRI findings were equivocal in suspected recurrent brain metastases.

What is RAD101 and how does it work in imaging recurrent brain metastases for Radiopharm Theranostics (RADX)?

RAD101 is a novel Fluorine-18-labeled small-molecule imaging agent targeting fatty acid synthase (FASN). According to Radiopharm Theranostics, FASN is overexpressed in cerebral metastases, and selective binding may enable more accurate PET-based detection of cancer cells in the central nervous system, complementing conventional MRI imaging.

What does FDA Fast Track Designation for RAD101 mean for Radiopharm Theranostics (RADX) investors?

RAD101 has received FDA Fast Track Designation to help distinguish recurrent disease from treatment effect in brain metastases. According to Radiopharm Theranostics, this status is intended to facilitate development and review of RAD101, potentially streamlining regulatory interactions for its planned registrational Phase 3 program.

How does the Siemens Healthineers partnership support the RAD101 Phase 3 trial in the U.S. for Radiopharm Theranostics (RADX)?

Radiopharm Theranostics partnered with Siemens Healthineers to manufacture and distribute 18F-labeled RAD101 doses in the U.S. According to the company, this collaboration will supply investigational product for the upcoming Phase 3 registrational trial of RAD101 in suspected recurrent brain metastases.

When does Radiopharm Theranostics (RADX) expect RAD101 to be Phase 3-ready, and what are the next clinical steps?

Radiopharm Theranostics aims for RAD101 to be Phase 3-ready by year-end 2026. According to the company, the upcoming October 1, 2026 End-of-Phase 2 FDA meeting should clarify pivotal trial design, enabling finalization of plans for a registrational Phase 3 study in recurrent brain metastases.

What unmet medical need is Radiopharm Theranostics (RADX) targeting with RAD101 in brain metastases diagnosis?

RAD101 targets diagnostic challenges in suspected recurrent brain metastases, where MRI can be equivocal after radiotherapy. According to Radiopharm Theranostics, PET imaging with RAD101 may help distinguish recurrent disease from treatment effect across metastases from various solid tumors, including leptomeningeal involvement.