This section highlights FDA-related milestones and regulatory updates for drugs developed by Radiopharm Theranostics (RADX).
Over the past two years, Radiopharm Theranostics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
18F-RAD101, RAD301, RV-01, RAD202, RAD, Rad, and 177Lu-RAD204. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
18F-RAD101 FDA Regulatory Events
18F-RAD101 is a drug developed by Radiopharm Theranostics for the following indication: in suspected recurrent brain metastasis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- 18F-RAD101
- Announced Date:
- September 14, 2026
- Indication:
- in suspected recurrent brain metastasis.
Announcement
Radiopharm Theranostics announced that positive data from an interim analysis of the Company’s Phase 2b imaging clinical trial (NCT06777433) of 18F-RAD101 (RAD101) in participants with suspected recurrent brain metastases from solid tumors has been selected for a late-breaking oral presentation at the 31st Annual Meeting of the Society of Neuro-Oncology (SNO26), taking place from November 12-15, 2026 in Philadelphia.
Read Announcement- Drug:
- 18F-RAD101
- Announced Date:
- April 28, 2025
- Indication:
- in suspected recurrent brain metastasis.
Announcement
Radiopharm Theranostics nnounced the dosing of the first patient in its U.S. Phase 2b imaging study of 18F-RAD101 in suspected recurrent brain metastasis.
AI Summary
Radiopharm Theranostics has dosed the first patient in its U.S. Phase 2b imaging study of 18F-RAD101, a novel diagnostic agent designed to detect suspected recurrent brain metastases. The multicenter, open-label trial will enroll 30 patients with confirmed recurrent brain metastases from various solid tumors. The study’s primary objective is to compare the detection results of 18F-RAD101 with those of conventional imaging using MRI with gadolinium, aiming to improve diagnostic accuracy. 18F-RAD101 targets fatty acid synthase—an enzyme overexpressed in many tumors—allowing for more precise identification of cancer cells. This early step in clinical testing could lead to a more reliable way to distinguish between tumor recurrence and treatment effects like radiation injury, potentially paving the way for more individualized and effective treatment decisions for patients suffering from brain metastases.
Read Announcement
RAD301 FDA Regulatory Events
RAD301 is a drug developed by Radiopharm Theranostics for the following indication: Pancreatic Ductal Adenocarcinoma (PDAC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- RAD301
- Announced Date:
- September 9, 2026
- Indication:
- Pancreatic Ductal Adenocarcinoma (PDAC).
Announcement
Radiopharm Theranostics announced positive data from the Phase 1 imaging trial designed to evaluate the safety, biodistribution and dosimetry of RAD 301 in healthy volunteers and subjects with Pancreatic Ductal Adenocarcinoma (PDAC).
Read Announcement
RV-01 FDA Regulatory Events
RV-01 is a drug developed by Radiopharm Theranostics for the following indication: For the 4Ig isoform.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- RV-01
- Announced Date:
- August 26, 2026
- Indication:
- For the 4Ig isoform
Announcement
Radiopharm Theranostics announced that it has dosed the first patient in the second cohort of its First-In-Human (FIH) Phase 1/2a clinical trial of RV-01 (177Lu-Betabart) in patients with B7-H3 expressing tumors.
Read Announcement- Drug:
- RV-01
- Announced Date:
- July 28, 2025
- Indication:
- For the 4Ig isoform
Announcement
Radiopharm Theranostics announced that the U.S. Food and Drug Administration (FDA) has provided clearance of the Company's Investigational New Drug (IND) application for Betabart (RV-01), its Lu177-B7H3 monoclonal antibody designed with strong affinity for the 4Ig isoform of B7H3 that is highly expressed in tumors and not in healthy tissues.
AI Summary
Radiopharm Theranostics announced that the FDA cleared its IND for Betabart, RV-01, a Lu177-B7H3 monoclonal antibody engineered to bind the 4Ig isoform of B7-H3, which is overexpressed in tumors, sparing healthy tissue.
This first-in-class radiopharmaceutical is set to begin a Phase 1 study in solid tumors in late 2025. CEO Riccardo Canevari called it a major milestone for Radiopharm and MD Anderson and plans to dose patients later this year.
Preclinical data showed RV-01 clears through the liver, giving the isotope time to target tumors while reducing toxicity. Because antibodies are processed by the liver, this route may lower side effects compared to kidney-cleared therapies.
RV-01’s selectivity for the 4Ig B7-H3 helps it ignore the 2Ig version, boosting tumor binding and reducing immune complex formation. Targeting this immune checkpoint, linked to aggressive cancers, may offer an option for resistant tumors.
Read Announcement
RAD202 FDA Regulatory Events
RAD202 is a drug developed by Radiopharm Theranostics for the following indication: to treat HER2-positive advanced and metastatic cancers.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- RAD202
- Announced Date:
- August 20, 2026
- Indication:
- to treat HER2-positive advanced and metastatic cancers
Announcement
Radiopharm Theranostics announced that it has received a positive recommendation from the Data Safety and Monitoring Committee (DSMC) to advance its clinical-stage radiotherapeutic asset, 177Lu-RAD202 (RAD202), to the next dose level of 180mCi in the Phase 1 ‘HEAT’ clinical trial in patients with Human Epidermal Growth Factor Receptor 2 (HER2)-positive advanced solid tumors1.
Read Announcement- Drug:
- RAD202
- Announced Date:
- October 1, 2025
- Indication:
- to treat HER2-positive advanced and metastatic cancers
Announcement
Radiopharm Theranostics announced that it has received a positive recommendation from the Data Safety and Monitoring Committee (DSMC) to advance its clinical-stage radiotherapeutic asset, 177Lu-RAD202 (RAD202), to the next dose level of 75mCi in the Phase 1 ‘HEAT' clinical trial in patients with Human Epidermal Growth Factor Receptor 2 (HER2)-positive advanced solid tumors. T
AI Summary
Radiopharm Theranostics announced that its Data Safety and Monitoring Committee (DSMC) has recommended advancing its experimental radiotherapy, 177Lu-RAD202, to a 75 mCi dose in the Phase 1 HEAT trial for HER2-positive advanced solid tumors.
After treating the first patient cohort with 30 mCi, the DSMC—an independent group that reviews safety and study data—found positive safety, drug distribution, and pharmacokinetic results.
The approval lets the trial continue without changes and begin enrolling patients in the second cohort at 75 mCi, expected by Q4 2025.
This trial, conducted at clinical centers across Australia, aims to identify the best dose for Phase 2 testing and explores a new treatment option for patients with difficult-to-treat HER2-positive cancers.
Data from the first two cohorts are planned for release by year-end 2025, marking an important step toward potential cancer therapy breakthroughs.
Read Announcement
RAD 101 FDA Regulatory Timeline and Events
RAD 101 is a drug developed by Radiopharm Theranostics for the following indication: For for successful detection of brain metastases.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- RAD 101
- Announced Date:
- August 17, 2026
- Indication:
- For for successful detection of brain metastases
Announcement
Radiopharm Theranostics 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.
Read Announcement- Drug:
- RAD 101
- Announced Date:
- July 22, 2026
- Indication:
- For for successful detection of brain metastases
Announcement
Radiopharm Theranostics 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.
AI Summary
Radiopharm Theranostics announced positive results from all 30 evaluable patients in its Phase 2b trial of RAD101 for people with suspected return of brain metastases after radiotherapy. The study met its main goal, with RAD101 PET showing 93% agreement with MRI across all evaluable lesions. This suggests the scan can help identify active tumors when MRI findings are unclear. The trial also showed early signs of strong performance in a smaller follow-up group: among 14 patients with available six-month follow-up and biopsy data, RAD101 reached 86% sensitivity, meaning it correctly found most cases of disease.
The company said it expects specificity data in Q4 2026 and plans to move RAD101 into a U.S. Phase 3 pivotal trial in Q4 2026. Radiopharm also noted that there is currently no approved PET product for this brain metastases imaging market, which it estimates at about $600 million.
Read Announcement- Drug:
- RAD 101
- Announced Date:
- April 16, 2026
- Indication:
- For for successful detection of brain metastases
Announcement
Radiopharm Theranostics announced that Clinical trial readout (Primary endpoint) expected in June 2026
AI Summary
Radiopharm Theranostics reported interim clinical data showing RAD 101 matched MRI results 90% of the time for the study’s primary endpoint. The company expects the full clinical trial readout on that primary endpoint in June 2026.
Based on these results, Radiopharm plans to advance RAD 101 into a U.S. Phase 3 pivotal trial. RAD 101 is a new imaging molecule that targets fatty acid synthase (FASN), an enzyme often overexpressed in many solid tumors, including brain metastases. By targeting FASN, RAD 101 aims to more accurately detect cancer cells in the brain.
Company leaders thanked patients, families, caregivers, investigators, and top recruiting centers for their support and said the recruitment process went very well as the program moves toward its next regulatory and clinical milestones. The June 2026 readout will determine whether RAD 101 proceeds into the pivotal trial and inform regulatory planning.
Read Announcement- Drug:
- RAD 101
- Announced Date:
- April 16, 2026
- Indication:
- For for successful detection of brain metastases
Announcement
Radiopharm Theranostics 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.
AI Summary
Radiopharm Theranostics announced the final patient has been dosed in its U.S. Phase 2b imaging trial (NCT06777433) evaluating RAD 101 in people with confirmed recurrent brain metastases from various solid tumors. Interim data so far show 90% concordance with MRI, the study’s primary endpoint, supporting the agent’s potential to match standard imaging for detecting brain metastases.
The company expects the clinical trial readout for the primary endpoint in June 2026 and plans to advance RAD 101 into a U.S. Phase 3 pivotal trial. Those next steps will rely on the full Phase 2b results to confirm performance and inform pivotal study design.
RAD 101 is a novel imaging small molecule that targets fatty acid synthase (FASN), an enzyme often overexpressed in solid tumors including brain metastases. The company thanked patients, families, caregivers, investigators and top recruiting sites for their contributions to the trial.
Read Announcement- Drug:
- RAD 101
- Announced Date:
- March 24, 2026
- Indication:
- For for successful detection of brain metastases
Announcement
Radiopharm Theranostics announced the second interim data from twenty patients in its U.S. Phase 2b clinical imaging trial of RAD 101 in brain metastases.
AI Summary
Radiopharm Theranostics announced second interim results from 20 patients in its U.S. Phase 2b imaging trial of RAD 101 for brain metastases. At interim analysis, 90% (18 of 20) of dosed and evaluable patients showed concordance between RAD 101 PET imaging and MRI, the trial’s primary endpoint. Scans showed significant and selective uptake of RAD 101 in brain metastases and confirmed metabolic activity in lesions that were equivocal on MRI.
Early secondary data from the first five patients with six‑month follow‑up and biopsy show an encouraging trend in sensitivity and specificity, though numbers are small and longer follow‑up is needed.
The company will host a webinar on Wednesday, 25 March 2026 at 9:00 am AEDT (Tuesday, 24 March at 6:00 pm EST). Presenters include CEO Riccardo Canevari, CMO Dr. Dimitris Voliotis, and Dr. Harshad Kulkarni. Register at: https://us02web.zoom.us/webinar/register/WN_Uy9zCUEhQUaMqC1rYG5Zhw. A recording will be posted after the live event.
Read Announcement- Drug:
- RAD 101
- Announced Date:
- January 28, 2026
- Indication:
- For for successful detection of brain metastases
Announcement
Radiopharm Theranostics announced Business Updates
AI Summary
Radiopharm Theranostics announced business updates on its radiotherapeutic pipeline and finances. Interim Phase 2b results for RAD101 showed 92% concordance with MRI among the first 12 patients, the study’s primary endpoint. If confirmed, this could lead to a Phase 3 registrational trial.
RAD202 and RAD204: additional Phase 1 cohort data are expected mid-2026. RAD204 continues in PD-L1-driven cancers, including NSCLC and TNBC; prior imaging in 16 NSCLC patients showed safety and acceptable dosimetry. RV-01 (Lu177), developed via Radiopharm Ventures with MD Anderson, showed tumor shrinkage in preclinical studies.
RAD402 (Tb161) received ethics approval in Australia to start a first-in-human Phase 1 trial, planned for Q1 2026. Ga68-RAD301 Phase 1 pancreatic imaging has dosed 8 of 9 patients; initial six showed safety and strong lesion uptake, and the company plans to study loco-regional disease. Cash of about $34.52 million provides runway into 2027 to advance key programs.
Read Announcement- Drug:
- RAD 101
- Announced Date:
- December 15, 2025
- Indication:
- For for successful detection of brain metastases
Announcement
Radiopharm Theranostics announced interim data from the first twelve patients in its U.S. Phase 2b clinical imaging trial of RAD 101 in brain metastases.
AI Summary
Radiopharm Theranostics reported interim results from the first 12 patients in its U.S. Phase 2b imaging trial of RAD 101 for suspected recurrent brain metastases. At this early readout, 92% (11 of 12) of evaluable patients met the trial’s primary endpoint of concordance between RAD 101 PET and MRI. PET scans showed significant and selective uptake of RAD 101 in brain lesions, confirming metabolic activity in areas where MRI findings were equivocal.
RAD 101 is a Fluorine-18 labeled small molecule that targets fatty acid synthase (FASN) using the company’s Pivalate technology. The open-label, single-arm Phase 2b study plans to enroll 30 participants and will assess concordance with contrast MRI as the primary outcome, with secondary measures including accuracy, sensitivity and specificity for distinguishing tumor recurrence from radiation necrosis. Company leaders said the interim data support moving toward a pivotal study by the end of 2026.
Read Announcement- Drug:
- RAD 101
- Announced Date:
- October 20, 2025
- Indication:
- For for successful detection of brain metastases
Announcement
Radiopharm Theranostics nnounced an update on its pipeline of clinical programs and outlined expected milestones through the end of 2025 and into 2026.
Read Announcement- Drug:
- RAD 101
- Announced Date:
- June 11, 2025
- Indication:
- For for successful detection of brain metastases
Announcement
Radiopharm Theranostics announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for RAD101 to distinguish between recurrent disease and treatment effect of brain metastases originating from solid tumors of different origin including leptomeningeal disease.
AI Summary
Radiopharm Theranostics announced that the FDA has granted Fast Track Designation for its novel imaging agent, RAD101. This special status is intended to speed up the development and review of the drug, which is designed to distinguish between recurrent brain metastases and treatment effects, such as those seen from radiation therapy. RAD101 targets fatty acid synthase (FASN), an enzyme often overexpressed in various solid tumors, including those that spread to the brain and cause leptomeningeal disease.
The FDA’s decision recognizes the critical need for improved diagnostic tools to better differentiate true tumor recurrence from treatment-related changes. With over 300,000 patients diagnosed with brain metastases each year in the U.S., RAD101 promises to enhance clinical decision-making and patient outcomes by providing more precise imaging results. The company is advancing Phase 2 clinical trials to further evaluate RAD101’s effectiveness.
Read Announcement- Drug:
- RAD 101
- Announced Date:
- February 10, 2025
- Indication:
- For for successful detection of brain metastases
Announcement
Radiopharm Theranostics announce the publication of a novel imaging approach demonstrating proof-of-concept for the use of RAD 101 for successful detection of brain metastases (both treatment-naïve and previously treated) from a variety of primary solid tumors.
AI Summary
Radiopharm Theranostics announced the publication of a novel imaging approach using RAD 101 (18F-Pivalate) to detect brain metastases. The clinical study, published in the European Journal of Nuclear Medicine and Molecular Imaging, demonstrated proof-of-concept for RAD 101’s ability to successfully detect brain metastases. A total of 22 patients were included, with both treatment-naïve and previously treated metastases from a variety of solid tumors being accurately identified. The study showed that RAD 101, used as part of a hybrid PET-mpMRI technique, provided a high tumor-to-background ratio, enhancing the visibility of the metastases. This promising imaging approach leverages the radiotracer's targeting of fatty acid metabolism—a process upregulated in many cancers—and may improve early and precise diagnosis of brain metastases.
Read Announcement
Rad 402 FDA Regulatory Events
Rad 402 is a drug developed by Radiopharm Theranostics for the following indication: For Metastatic Or Locally Advanced Prostate Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Rad 402
- Announced Date:
- March 27, 2026
- Indication:
- For Metastatic Or Locally Advanced Prostate Cancer
Announcement
Radiopharm Theranostics announced that the first patient has been dosed in its first-in-human Phase 1 clinical trial of RAD 402, a monoclonal antibody targeting KLK3 radiolabelled with Terbium 161 being evaluated in advanced prostate cancer.
AI Summary
Radiopharm Theranostics announced the first patient has been dosed in its first‑in‑human Phase 1 trial of RAD 402, a monoclonal antibody that targets KLK3 and is radiolabelled with terbium‑161. The study is evaluating RAD 402 in patients with advanced prostate cancer.
Terbium‑161’s “dual emission” profile is being highlighted as an innovative approach: it can deliver focused radiation to tumor cells while also providing signals useful for tracking distribution. Radiopharm positions this as a way to combine targeted therapy with improved localization and potential imaging support during treatment.
Preclinical mouse xenograft studies showed strong tumor uptake of RAD 402, minimal bone and marrow exposure, and expected liver clearance. The company says it is on track to report data from the first two dose levels in the second half of 2026.Read Announcement
- Drug:
- Rad 402
- Announced Date:
- November 18, 2025
- Indication:
- For Metastatic Or Locally Advanced Prostate Cancer
Announcement
Radiopharm Theranostics announced that Previous comprehensive preclinical proof-of-concept Biodistribution studies of RAD 402 in mouse xenografts showed strong tumour targeting, limited bone and marrow uptake, and a hepatic excretion profile consistent with expectations for a monoclonal antibody.
AI Summary
Radiopharm Theranostics reported preclinical proof-of-concept biodistribution studies of RAD402 in mouse xenograft models. The studies found strong tumor targeting, meaning the agent concentrated well in tumor tissue. They also showed limited uptake in bone and bone marrow, and a hepatic excretion profile consistent with what is expected for a monoclonal antibody.
These results are important because strong, selective tumor uptake can improve treatment effectiveness, while low bone and marrow uptake reduces the chance of harming blood-forming tissues. A liver-based clearance route fits typical monoclonal antibody behavior and suggests predictable pharmacokinetics. Altogether, the data support RAD402’s continued development and provide a reassuring preclinical safety and targeting profile ahead of further testing.
Read Announcement
177Lu-RAD204 FDA Regulatory Events
177Lu-RAD204 is a drug developed by Radiopharm Theranostics for the following indication: in PD-L1 positive advanced cancers.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- 177Lu-RAD204
- Announced Date:
- November 12, 2025
- Indication:
- in PD-L1 positive advanced cancers
Announcement
Radiopharm Theranostics announced the completion of enrollment for the second cohort of patients in the Phase 1 dose escalation trial of 177Lu-RAD204 in PD-L1 positive advanced cancers, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), triple-negative breast cancer (TNBC), cutaneous melanoma, head and neck squamous cell carcinoma (HNSCC) and endometrial cancer.
AI Summary
Radiopharm Theranostics announced it has completed enrollment for the second cohort in the Phase 1 dose‑escalation trial of 177Lu‑RAD204 in PD‑L1 positive advanced cancers. The basket trial includes non‑small cell lung cancer (NSCLC), small cell lung cancer (SCLC), triple‑negative breast cancer (TNBC), cutaneous melanoma, head and neck squamous cell carcinoma (HNSCC) and endometrial cancer.
The Data Safety Monitoring Committee has approved advancing to a higher therapeutic dose of 90 mCi for the third cohort. Results from the first two cohorts showed clear tumor uptake of the radiopharmaceutical and a favorable safety profile, allowing the study to proceed with dose escalation.
The open‑label Phase 1 study is assessing safety, tolerability, biodistribution, radiation dosimetry and early anti‑tumor activity of 177Lu‑RAD204, a Lutetium‑177 radiolabeled single‑domain antibody that targets PD‑L1. Radiopharm will continue collecting patient data to evaluate potential clinical benefits for people with PD‑L1 positive advanced cancers.
Read Announcement
177Lu-RAD20 FDA Regulatory Events
177Lu-RAD20 is a drug developed by Radiopharm Theranostics for the following indication: In patients with PD-L1 positive advanced cancers.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- 177Lu-RAD20
- Announced Date:
- May 12, 2025
- Target Action Date:
- H1 2025
- Estimated Target Date Range:
- January 1, 2025 - June 30, 2025
- Indication:
- In patients with PD-L1 positive advanced cancers
Announcement
Radiopharm Theranostics announced that On track to complete the enrollment of the first two cohorts by mid-2025
AI Summary
Radiopharm Theranostics announced a promising update on its Phase 1 clinical trial for the radiotherapeutic asset 177Lu-RAD204, aimed at treating PD-L1 positive advanced cancers. The independent Data and Safety Monitoring Committee confirmed positive safety, pharmacokinetic, and biodistribution data from the first cohort, allowing the trial to proceed without modifications. With this approval, the study will now progress to a higher dose cohort, increasing the starting dose from 40 mCi to 60 mCi for the next group of patients.
The company stated it is on track to complete the enrollment of the first two cohorts by mid-2025. This accelerated timeline, along with the expansion into multiple tumor types, could improve clinical outcomes for patients by offering new treatment options in areas with high unmet medical needs.
Read Announcement- Drug:
- 177Lu-RAD20
- Announced Date:
- May 12, 2025
- Indication:
- In patients with PD-L1 positive advanced cancers
Announcement
Radiopharm Theranostics announced that it has achieved a key milestone in its ongoing clinical development program for its clinical-stage radiotherapeutic asset, 177Lu-RAD204, as the Data and Safety Monitoring Committee (DSMC) has approved to proceed to the next dose in its Phase 1 clinical trial in patients with PD-L1 positive advanced cancers1.
AI Summary
Radiopharm Theranostics has reached a major milestone in the development of its radiotherapeutic asset, 177Lu-RAD204. The company announced that the independent Data and Safety Monitoring Committee (DSMC) approved moving to the next dose level in its Phase 1 clinical trial for patients with PD-L1 positive advanced cancers. After reviewing data from the first cohort of four patients treated at 30mCi, the DSMC found the safety, pharmacokinetics, and biodistribution results positive and recommended continuing the study without any modifications.
With this approval, the trial will progress to a higher dose cohort at 60mCi, replacing the previously assumed 40mCi. This change supports expanding enrollment across various tumor types and additional active centers. Radiopharm Theranostics now expects to complete the enrollment of the next cohort by mid-2025, marking another step forward in potentially offering better treatment outcomes for patients with advanced cancers.
Read Announcement
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