Radiopharm Theranostics Completes Enrollment in U.S. Phase 2b Imaging Trial of RAD 101 for Diagnosis of Brain Metastases

Radiopharm Theranostics (NASDAQ:RADX) completed enrollment in its U.S. Phase 2b imaging trial of RAD 101 for recurrent brain metastases, dosing the final patient in a 30-participant study.

Rhea-AI Summary

Radiopharm Theranostics (NASDAQ:RADX) completed enrollment in its U.S. Phase 2b imaging trial of RAD 101 for recurrent brain metastases, dosing the final patient in a 30-participant study.

Interim data showed 90% concordance with MRI; a primary endpoint readout is expected in June 2026 and the company plans to advance RAD 101 toward a U.S. Phase 3 pivotal trial. RAD 101 has FDA Fast Track designation for distinguishing recurrent disease from treatment effect.

Positive

• Interim concordance of 90% with MRI
• Completed enrollment: 30 patients in U.S. Phase 2b
• Has FDA Fast Track designation
• Plans to advance to a U.S. Phase 3 pivotal trial

Negative

• Single-arm, open-label design with only 30 participants
• Primary endpoint readout delayed until June 2026

Argus Apr 16 session

-0.22% close to close Open Argus

Details

News Market Reaction – RADX

On Apr 16, the day this news came out, RADX closed 0.22% below the previous close.

Data tracked by StockTitan Argus for the Apr 16 session.

Market Context

This announcement marks full enrollment in the U.S. Phase 2b trial of RAD 101 for recurrent brain me...

Analysis

This announcement marks full enrollment in the U.S. Phase 2b trial of RAD 101 for recurrent brain metastases, building on interim data showing 90% concordance with MRI and existing FDA Fast Track Designation. It signals progress toward a planned U.S. Phase 3 pivotal trial and potential regulatory discussions. Investors may watch for the June 2026 primary endpoint readout, durability of diagnostic performance in all 30 patients, and how this program integrates with Radiopharm’s broader radiopharmaceutical pipeline.

Key Figures

MRI concordance: 90% Primary endpoint readout: June 2026 Phase 2b sample size: 30 individuals +3 more

MRI concordance

90%

Interim Phase 2b data primary endpoint concordance with MRI

Primary endpoint readout

June 2026

Expected Phase 2b primary endpoint clinical trial readout

Phase 2b sample size

30 individuals

U.S. multicenter open-label single arm Phase 2b trial

Annual cerebral metastases

more than 300,000 patients

Estimated U.S. incidence of cerebral metastases annually

Trial phase

Phase 2b

Imaging trial of RAD 101 in recurrent brain metastases

FDA Fast Track

Granted

RAD 101 to distinguish recurrent disease vs treatment effect in brain metastases

Historical Context

5 past events · Latest: Apr 08

5 events

1. Apr 08

   Dose escalation update

   24h Move

   +3.0%

   DSMC cleared 177Lu-RAD202 escalation to 130mCi (Cohort 3) in HEAT trial.

2. Apr 07

   Supply agreement

   24h Move

   -1.6%

   U.S. supply deal with Siemens Healthineers plus 90% RAD101 PET–MRI concordance.

3. Mar 27

   First patient dosed

   24h Move

   +0.0%

   First patient dosed in Phase 1 RAD 402 trial for advanced prostate cancer.

4. Mar 24

   Interim trial data

   24h Move

   -10.8%

   Second interim RAD 101 data showed 90% PET–MRI concordance on primary endpoint.

5. Feb 24

   First patient dosed

   24h Move

   +1.8%

   First patient dosed in Phase 1/2a trial for 177Lu‑BetaBart (RV‑01) radiotherapeutic.

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

Key Terms

phase 2b, phase 3 pivotal trial, fatty acid synthase (fasn), fast track designation, +4 more

8 terms

phase 2b medical

"final patient has been dosed in the U.S. Phase 2b imaging 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

"Plans to advance RAD 101 into 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.

fatty acid synthase (fasn) medical

"targets fatty acid synthase (FASN), a multi-enzyme protein that catalyses fatty acid synthesis"

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.

fast track designation regulatory

"RAD 101 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.

leptomeningeal disease medical

"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.

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.

contrast-enhanced magnetic resonance imaging (ce-mri) medical

"Contrast-enhanced Magnetic Resonance Imaging (CE-MRI) is the preferred method"

An contrast-enhanced magnetic resonance imaging (ce-MRI) scan is a medical imaging test that uses strong magnets and a safe injectable dye to make organs, blood vessels and abnormal tissue show up more clearly on pictures. For investors, ce-MRI matters because it can change how accurately a condition is diagnosed, how well a treatment’s effects are measured in clinical trials, and therefore influence regulatory decisions, market adoption, and sales for diagnostics, drugs and medical devices — like adding dye to water to reveal hidden leaks.

open-label medical

"The U.S. multicenter, open-label, single arm Phase 2b clinical trial"

Open-label describes a situation where everyone involved in a study or process knows the full details, such as who is receiving a treatment or intervention. For investors, understanding whether a project or product is open-label helps gauge the level of transparency and potential biases, influencing trust and decision-making. It’s like knowing whether a test or experiment is conducted openly or behind closed doors.

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

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

Interim data to date showed 90% concordance with MRI (the primary endpoint)

Clinical trial readout (Primary endpoint) expected in June 2026

Plans to advance RAD 101 into U.S. Phase 3 pivotal trial

SYDNEY, April 16, 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 needs, today announced that the final patient has been dosed in the U.S. Phase 2b imaging trial (NCT06777433) evaluating RAD 101 in individuals with confirmed recurrent brain metastases from solid tumors of different origins.

“Dosing the final patient in our most advanced diagnostic program represents an important milestone for Radiopharm and underscores the continued momentum of our radiopharmaceutical pipeline,” said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. “The interim results we have seen to date, demonstrating a high level of concordance with MRI, reinforce our confidence in RAD 101’s potential to address a critical unmet need in the accurate detection of recurrent brain metastases. As we look ahead to the full data readout in June, we are focused on advancing this important program into U.S. pivotal trial and initiating constructive dialogue with the FDA to define the optimal regulatory pathway. We believe RAD 101 has the potential to meaningfully improve clinical decision-making for patients and physicians navigating this challenging disease.”

“I would like to take the opportunity to thank all the patients, families, and caregivers for their trust in our clinical trial. The investigators and the Clinical Center did an amazing job in the recruitment process, and our congratulations go to BAMF HEALTH for leading the table of the top recruiters,” added Mr. Canevari.

RAD 101 is the Company’s novel imaging small molecule that targets fatty acid synthase (FASN), a multi-enzyme protein that catalyses fatty acid synthesis and is overexpressed in many solid tumors, including cerebral metastasis. Targeting FASN activity may allow for the more accurate detection of cancer cells, representing a clinically relevant method for the imaging of brain metastases.

The U.S. multicenter, open-label, single arm Phase 2b clinical trial is evaluating the diagnostic performance of 18F-RAD101 in 30 individuals with confirmed recurrent brain metastases from solid tumors of different origins. The primary objective of the study is concordance between 18F-RAD101 positive lesions and those seen in conventional imaging (MRI with gadolinium) in participants with suspected recurrent brain metastases. RAD 101 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.

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 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.

Authorized on behalf of the Radiopharm Theranostics Board of Directors by Executive 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

Paul Hopper
Executive Chairman
P: +61 406 671 515
E: paulhopper@lifescienceportfolio.com

Media
Matt Wright
NWR Communications
P: +61 451 896 420
E: matt@nwrcommunications.com.au

Follow Radiopharm Theranostics:

Website – https://radiopharmtheranostics.com/
Twitter – https://twitter.com/TeamRadiopharm  
Linked In – https://www.linkedin.com/company/radiopharm-theranostics/
InvestorHub – https://investorhub.radiopharmtheranostics.com/

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

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did RADX announce on April 16, 2026 about RAD 101 Phase 2b?

Radiopharm announced it completed enrollment and dosed the final patient in a 30-patient U.S. Phase 2b trial. According to the company, interim data showed 90% concordance with MRI and a full readout is expected in June 2026.

When will RADX report the Phase 2b primary endpoint for RAD 101?

The company expects the Phase 2b primary endpoint readout in June 2026. According to the company, that readout will assess concordance between 18F-RAD101 positive lesions and MRI findings in enrolled participants.

What does the reported 90% concordance with MRI mean for RADX investors?

It indicates strong alignment between RAD 101 imaging and conventional MRI in interim data. According to the company, this 90% concordance supports RAD 101's potential diagnostic value and informs plans for a U.S. pivotal Phase 3 trial.

Will RADX advance RAD 101 to a Phase 3 pivotal trial?

The company plans to advance RAD 101 into a U.S. Phase 3 pivotal trial pending Phase 2b readout and regulatory dialogue. According to the company, discussions with the FDA will aim to define the optimal regulatory pathway.

What is the significance of FDA Fast Track designation for RAD 101 (RADX)?

Fast Track may expedite development and FDA interactions for RAD 101 addressing recurrent brain metastases. According to the company, the designation targets distinguishing recurrent disease from treatment effect in patients with metastatic brain tumors.