Radiopharm Theranostics Achieves Primary Endpoint In 90% of Patients At Second Interim Analysis of RAD 101 Phase 2b Imaging Trial in Brain Metastases

Radiopharm Theranostics (ASX:RADX) reported second interim Phase 2b imaging results for RAD 101 in brain metastases on March 24, 2026.

Rhea-AI Summary

Radiopharm Theranostics (ASX:RADX) reported second interim Phase 2b imaging results for RAD 101 in brain metastases on March 24, 2026. Ninety percent (18/20) of dosed, evaluable patients achieved PET–MRI concordance (primary endpoint), with selective tumor uptake and metabolic signal versus equivocal MRI.

First five patients with six‑month follow‑up/biopsy show an encouraging trend for sensitivity and specificity (secondary objectives). FDA Fast Track designation is in place; full 30‑patient readout expected by June 2026. Webinar scheduled March 24–25, 2026.

Positive

• 90% concordance at second interim (18/20 patients)
• Selective tumor uptake and confirmatory metabolic PET imaging
• FDA Fast Track designation for RAD 101
• Full 30‑patient readout by June 2026 to guide pivotal plan

Negative

• Interim dataset is small: 20 patients to date
• Only five patients have evaluable six‑month follow‑up/biopsy
• Phase 2b status means regulatory approval and commercialization are not imminent

Argus Mar 24 session

-10.78% close to close Open Argus

Details

News Market Reaction – RADX

On Mar 24, the day this news came out, RADX closed 10.78% below the previous close.

Data tracked by StockTitan Argus for the Mar 24 session.

Market Context

On Mar 24, the day this news came out, the stock closed 10.8% below the previous close. A negative r...

Analysis

On Mar 24, the day this news came out, the stock closed 10.8% below the previous close. A negative reaction despite encouraging RAD101 data would fit a pattern where not all clinical updates translate into gains, as seen with at least one prior trial milestone. With shares already trading well below the 200-day MA and far under the 52-week high, further weakness could reflect concerns about financing flexibility under the existing Form F-3 or skepticism about interim imaging endpoints ahead of pivotal trial design.

Key Figures

Primary endpoint concordance: 90% (18/20 patients) Interim patient count: 20 patients Six-month follow-up subset: 5 patients +2 more

Primary endpoint concordance

90% (18/20 patients)

Second interim analysis of RAD 101 Phase 2b imaging trial

Interim patient count

20 patients

U.S. Phase 2b RAD 101 imaging trial interim dataset

Six-month follow-up subset

5 patients

Patients with six‑month follow-up and/or biopsy data

Planned study size

30 patients

Total target enrollment for RAD 101 Phase 2b study

Cerebral metastases incidence

More than 300,000 patients annually

Estimated U.S. annual diagnoses of cerebral metastases

Previous Clinical trial Reports

5 past events · Latest: Feb 24

Same Type 5 events

1. Feb 24

   BetaBart trial start

   24h Move

   +1.8%

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

2. Dec 15

   RAD101 interim data

   24h Move

   +149.5%

   Phase 2b interim RAD101 data showed 92% MRI concordance and strong uptake.

3. Nov 18

   RAD402 trial approval

   24h Move

   -4.8%

   Ethics approval to initiate Phase 1 trial of RAD402 in prostate cancer.

4. Nov 17

   RAD101 enrollment 50%

   24h Move

   +2.6%

   RAD101 Phase 2b reached 50% enrollment with encouraging early imaging data.

5. Nov 12

   RAD204 dose escalation

   24h Move

   +2.0%

   Data Safety Monitoring Committee cleared escalation to 90 mCi in RAD204 trial.

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

Key Terms

pet imaging, mri, sensitivity and specificity, fast track designation, +3 more

7 terms

pet imaging medical

"The second interim analysis showed that 90% (18/20) of the patients dosed with RAD101 achieved concordance between PET imaging and MRI"

PET imaging is a noninvasive medical scan that works like a molecular camera, using tiny radioactive tracers to reveal biological activity inside the body—for example metabolism, blood flow, or the presence of specific proteins. It matters to investors because PET results guide diagnosis, show whether a drug reaches its intended target and how patients respond, and therefore affect clinical trial success, regulatory approval, reimbursement decisions and demand for scanners, tracers and related services.

mri medical

"Images confirm metabolic activity in brain metastases compared to equivocal MRI findings."

Magnetic resonance imaging (MRI) is a medical scan that uses magnetic fields and radio waves to create detailed pictures of the inside of the body, like a high-resolution camera for tissues and organs. Investors care because MRI drives demand for imaging machines, hospital services, diagnostics and can be central to clinical trial results and regulatory decisions—changes in MRI use or technology can affect revenue, capital spending and reimbursement in healthcare and medical device markets.

sensitivity and specificity medical

"the first five patients with evaluable six-month follow-up and/or biopsy data show a positive trend for sensitivity and specificity"

Sensitivity and specificity are two measures of how well a diagnostic test or screening correctly identifies who does and does not have a condition: sensitivity is the share of true positives found, while specificity is the share of true negatives correctly excluded. For investors, they matter because higher sensitivity and specificity reduce missed cases and false alarms, which affects clinical trial outcomes, regulatory approval, market acceptance and reimbursement—think of sensitivity as a smoke alarm’s ability to detect real fires and specificity as its ability not to cry wolf.

fast track designation regulatory

"RAD 101 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.

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 for imaging IMD"

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.

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

90% of patients dosed with RAD 101 and evaluable at interim analysis achieved concordance with MRI imaging (the primary endpoint)

First five patients with available data from six-month follow-up and biopsy show encouraging trend for Sensitivity and Specificity (secondary objective)

Company to host webinar on March 25 at 9:00 am AEDT (Sydney, Melbourne) / Tuesday, March 24 at 6:00 pm EST (U.S.)

SYDNEY, Australia, March 24, 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 the second interim data from twenty patients in its U.S. Phase 2b clinical imaging trial of RAD 101 in brain metastases. RAD 101 is Radiopharm’s novel, small-molecule imaging agent targeting fatty acid synthase (FASN) and radiolabelled with Fluorine-18 for the diagnosis of suspected recurrent brain metastases from solid tumors of different origins.

The second interim analysis showed that 90% (18/20) of the patients dosed with RAD101 achieved concordance between PET imaging and MRI (the primary endpoint). The results showed significant and selective tumor uptake in the brain metastases. Images confirm metabolic activity in brain metastases compared to equivocal MRI findings.

In addition, the first five patients with evaluable six-month follow-up and/or biopsy data show a positive trend for sensitivity and specificity (the secondary objectives). Sensitivity and specificity are two of the fundamental hallmarks of any diagnostic test including in imaging. They measure an imaging test's ability to correctly identify patients with a disease (sensitivity, true positive rate), as well as patients without the disease (specificity, true negative rate).

“The strength and consistency of these interim results further validate the potential of RAD 101 to address one of the most challenging diagnostic gaps in neuro-oncology,” said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. “With 90% concordance demonstrated to date and encouraging early signals in sensitivity and specificity, we are increasingly confident in RAD 101’s ability to support more accurate and timely treatment decisions for patients with brain metastases. We look forward to the final data readout from the full 30-patient study by June, which will guide our path toward a pivotal trial and, ultimately, toward bringing this important imaging agent to the clinicians and patients who need it.”

RAD 101 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.

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 

WEBINAR DETAILS

AUSTRALIA
Date: Wednesday 25 March 2026
Time: 9:00am AEDT

USA
Date: Tuesday 24 March 2026
Time: 6.00pm EDT

Presenters:

• Riccardo Canevari – CEO & Managing Director
• Dr Dimitris Voliotis – Chief Medical Officer
• Dr. Harshad Kulkarni – BAMF Health, Grand Rapids, MI
  

Register for the webinar at the link below: https://us02web.zoom.us/webinar/register/WN_Uy9zCUEhQUaMqC1rYG5Zhw

Please submit any questions to: matt@nwrcommunications.com.au

Upon registering attendees will receive an email containing information about joining the webinar. A recording will be available at the above link soon after the conclusion of the live session, with the replay to also be made available via Radiopharm’s website and social media channels.

About the Phase 2 Clinical Trial of RAD101

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. Secondary endpoints are accuracy, sensitivity and specificity of RAD101 in identifying tumor recurrence versus radiation necrosis in previously stereotactic radiosurgery (SRS)-treated brain metastases.

About RAD101

RAD101 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. 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 four 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

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

___________________________

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 Radiopharm (RADX) report in the March 24, 2026 RAD 101 Phase 2b interim results?

The company reported 90% PET–MRI concordance (18/20 patients) at the second interim analysis. According to the company, images showed selective tumor uptake and metabolic activity versus equivocal MRI, supporting the primary endpoint in this imaging study.

How many patients are included and when is the full RAD 101 30‑patient readout expected for RADX?

Twenty patients are included in the second interim analysis; the study enrolls 30 total patients. According to the company, a full 30‑patient data readout is expected by June 2026, which will inform pivotal planning.

What do the secondary sensitivity and specificity signals mean for RAD 101 and RADX investors?

Early signals show a positive trend in sensitivity and specificity for RAD 101 in a small subset. According to the company, five patients with six‑month follow‑up/biopsy support encouraging trends, but the sample size remains limited for definitive performance estimates.

Does RAD 101 have regulatory designations that could affect development timelines for RADX?

Yes, RAD 101 has received FDA Fast Track designation, which can accelerate development and review. According to the company, this designation targets distinguishing recurrent disease from treatment effect in brain metastases.

What limitations should investors note about the RAD 101 interim data from Radiopharm (RADX)?

The main limitations are the early, small dataset and limited long‑term follow‑up. According to the company, only 20 patients were evaluable at interim and five have six‑month/biopsy data, constraining statistical confidence.

How can investors access Radiopharm (RADX) management commentary on the RAD 101 results?

Radiopharm is hosting a webinar March 24–25, 2026 with management and clinical leads presenting results. According to the company, registration details and a replay are available via the provided webinar link and company channels.