Theranostic Newsletter | 06.2025 Edition

Here’s your latest dose of Theranostic Insights—a curated snapshot of what’s new and next in the world of theranostics powered by TheranosticTrials.org. From clinical breakthroughs to tech trends, we’ve got the highlights you need to stay ahead.

Latest Theranostic News 📰

Novartis’ Pluvicto Shows Strong Results in PSMA-Positive Hormone-Sensitive Prostate Cancer
In the Phase III PSMAddition trial, Novartis’ radioligand therapy Pluvicto™ significantly improved radiographic progression-free survival in patients with PSMA-positive metastatic hormone-sensitive prostate cancer, when added to standard hormone therapy. This marks Pluvicto’s third positive Phase III readout and supports its potential use in earlier-stage disease, beyond its current FDA approval for mCRPC. Novartis plans to submit for regulatory review later this year. Continue reading here.

Clarity’s SABRE Trial Shows Cu-64 SAR-Bombesin Effectively Detects Prostate Cancer Missed by SOC Imaging
Clarity Pharmaceuticals has announced positive topline results from its Phase II SABRE trial, showing that Cu-64 SAR-Bombesin safely and effectively detects prostate cancer recurrence in patients with negative or equivocal standard-of-care (SOC) imaging, including PSMA PET scans. The novel radiopharmaceutical targets GRPR, offering a powerful alternative for identifying disease in PSMA-negative prostate cancers—often undetectable by current tools. In the trial, Cu-64 SAR-Bombesin revealed cancerous lesions in up to 43% of participants, with all biopsied lesions confirming true-positive results. These findings underscore the theranostic potential of SAR-Bombesin to fill a major diagnostic gap in prostate and other GRPR-expressing cancers.
Continue reading here.

Radiopharm Theranostics Doses First Patient in HEAT Trial Targeting HER2-Positive Cancers
Radiopharm Theranostics has launched its first-in-human Phase 1 HEAT trial, dosing the first patient with 177Lu-RAD202—a novel theranostic agent targeting HER2-positive advanced cancers. This milestone marks the company's transition to a clinical-stage biotech, evaluating the safety and efficacy of its radiolabelled nanobody therapy. Backed by promising preclinical and diagnostic data, the trial positions Radiopharm as a key player in the growing field of radiotheranostics. Continue reading here.

Ratio Therapeutics Partners with Nusano to Secure Key Isotopes for Theranostics
Ratio Therapeutics has entered a long-term supply agreement with Nusano to access critical medical isotopes—including Cu-64, Lu-177, and Ac-225—used in cancer imaging and targeted radiotherapy. The deal aims to overcome ongoing isotope supply challenges, accelerating Ratio’s theranostic pipeline, including its upcoming FAP-targeted therapy for soft tissue sarcoma. With both companies operating in Utah, the partnership also promises streamlined logistics and scalable radiopharmaceutical production.
Continue reading here.

Blue Earth Therapeutics Reports Strong Tumor Targeting in Phase 1 Trial of rhPSMA-10.1 at SNMMI
Blue Earth Therapeutics presented promising Phase 1 dosimetry data for its investigational radioligand therapy, Lutetium-177 rhPSMA-10.1, at SNMMI 2025. The study showed high radiation delivery to prostate cancer tumors with favorable tumor-to-organ ratios—up to 73:1 vs. salivary glands—supporting the potential for higher, front-loaded dosing without increasing toxicity. These findings validate the design of the ongoing Phase 2 trial, which aims to enhance therapeutic efficacy by maximizing tumor dose while sparing healthy tissue.
Continue reading here.

Telix’s Illuccix® Gains Approval in Germany, Expanding Access to PSMA-PET Imaging
Telix Pharmaceuticals has received marketing authorization in Germany for Illuccix®, a gallium-68-based PSMA-PET imaging agent used in the detection and staging of prostate cancer. With a broad clinical label, Illuccix will support diagnosis and treatment planning at multiple disease stages, including high-risk primary, recurrent, and metastatic castration-resistant prostate cancer. This approval addresses longstanding access issues by enabling on-site preparation and reducing reliance on fluorine-18 tracers. Telix will distribute Illuccix in partnership with Eckert & Ziegler SE. Continue reading here.

Clarity Pharmaceuticals Partners with SpectronRx to Scale Cu-SAR-bisPSMA Production for Prostate Cancer Theranostics
Clarity Pharmaceuticals has signed a major commercial manufacturing agreement with SpectronRx, enabling large-scale production of Cu-SAR-bisPSMA—a radiopharmaceutical targeting PSMA-expressing prostate cancer. With up to 400,000 units per year projected, this 5-year deal positions Clarity to meet growing demand as it prepares for FDA submission and commercialization. SpectronRx will also supply copper-64, a core component of Clarity’s Targeted Copper Theranostics (TCT) platform, reinforcing readiness for both clinical and commercial rollouts.
Continue reading here.

PSMA PET/CT Outperforms mpMRI and GRPR in Theranostic Imaging for Prostate Cancer
At SNMMI 2025, Dr. Yujia Li presented a prospective study comparing mpMRI, PSMA, and GRPR PET/CT for local staging in primary prostate cancer. PSMA PET/CT demonstrated the highest accuracy—particularly in pure adenocarcinoma cases—outperforming both GRPR and mpMRI in detecting bilateral intraprostatic disease and seminal vesicle invasion. Combining PET/CT with mpMRI significantly improved lesion detection and staging accuracy, supporting its growing role in theranostic imaging for precise diagnosis and treatment planning. Continue reading here.

SNMMI President Highlights Urgent Need to Expand Nuclear Medicine Access
In a recent interview, SNMMI President Dr. Jean-Luc C. Urbain emphasized the need to strengthen radiopharmaceutical supply chains and expand nuclear medicine access, particularly for underserved U.S. communities. With new FDA approvals driving a surge in demand—potentially up to sixfold—Dr. Urbain called for mobile imaging solutions and autonomous isotope production to bridge the care gap. He also noted the role of AI in optimizing delivery and access to theranostic technologies. Continue reading here.

First Clinical Trial Using DOE’s Accelerator-Produced Actinium-225 Set to Launch
This summer, the first FDA-approved clinical trial using accelerator-produced actinium-225 (Ac-225) from the U.S. Department of Energy will begin, marking a major advancement in targeted radiopharmaceutical cancer therapy. Produced at Brookhaven and Los Alamos National Laboratories, Ac-225 has long shown promise in preclinical studies but was limited by supply. Now, with a scalable domestic production method in place, this trial could open a new chapter in theranostics and expand access to life-saving isotopes. Continue reading here.

Alpha Fusion and Curadh Join Forces to Advance Astatine-211 Radiopharmaceuticals Globally
Alpha Fusion and Curadh MTR have announced a strategic partnership and joint venture aimed at accelerating the global development of Astatine-211 (At-211)-based radiopharmaceuticals. The collaboration will combine Alpha Fusion’s pioneering At-211 drug discovery and clinical work in Japan with Curadh’s development expertise to advance lead candidates in the U.S. and expand the pipeline. With At-211’s unique alpha-emitting properties and short half-life, this partnership marks a key step forward in next-generation theranostics. Continue reading here.

SNMMI: Botox Combo Shows Promise in Reducing Dry Mouth from PSMA Theranostics
Preliminary research presented at SNMMI 2025 suggests that botulinum toxin (IncoA) combined with transdermal scopolamine patches may significantly reduce salivary gland uptake of PSMA-targeted radiopharmaceuticals in prostate cancer patients. In a small study of men with mCRPC receiving 225Ac and 177Lu-PSMA therapy, Botox-treated glands showed up to 30% reduced PSMA uptake—potentially easing radiation-induced dry mouth without affecting tumor targeting. This approach could improve patient comfort and support broader access to PSMA theranostic therapies.
Continue reading here.

PharmaLogic Expands Global Theranostics Platform with Agilera Acquisition
PharmaLogic has acquired a majority stake in Norway-based Agilera Pharma AS, advancing its vision to build the first fully-integrated global CDMO platform for radiopharmaceutical therapeutics. The deal boosts PharmaLogic’s manufacturing, development, and international distribution capabilities, reinforcing its presence in over 30 countries. This strategic move strengthens PharmaLogic’s role in the growing theranostics space by expanding access to radiopharmaceutical therapies worldwide.
Continue reading here.

ITM and Debiopharm Launch New Theranostics Study Arm for Kidney Cancer Diagnosis
ITM and Debiopharm have imaged the first patient in a new arm of their Phase 1/2 trial evaluating ITM-94, a Gallium-68-labeled PET agent, for diagnosing clear cell renal cell carcinoma (ccRCC). Part of the broader ITM-91/ITM-94 theranostic program, this arm focuses on non-invasively distinguishing cancerous from non-cancerous renal masses, potentially reducing the need for biopsies. With promising early imaging results, this CAIX-targeted theranostic pair could significantly advance precision diagnosis and treatment of ccRCC and other CAIX-expressing tumors.
Continue reading here.

SNMMI: PET Imaging Detects Oligometastatic Breast Cancer 2.5x More Often Than Standard Imaging
At SNMMI 2025, a University of Toronto-led study revealed that PET imaging detects oligometastatic breast cancer (OMD) 2.5 times more frequently than conventional imaging methods. In a trial of 369 women with stage IIb or III breast cancer, F-18 FDG PET/CT uncovered both OMD and more extensive metastases more accurately—potentially improving selection for metastasis-directed therapy. These findings support expanding PET’s role in staging and treatment planning for breast cancer patients with limited metastases.
Continue reading here.

PanTera Delivers First Belgium-Made Actinium-225 for Theranostics from Thorium-229
PanTera has successfully produced and supplied its first batch of Actinium-225 (Ac-225) from Thorium-229 at its facility in Belgium, marking a major milestone for the global theranostics supply chain. Enabled by a partnership with TerraPower Isotopes, this initial delivery under PanTera’s “Early Supply” program will support over 1.5 curies of Ac-225 annually—benefiting thousands of cancer patients. The breakthrough underscores PanTera’s leadership in scaling targeted alpha therapy (TAT) radioisotope production, with plans to ramp up to over 100 curies per year through its upcoming Actinium Production Centre.
Continue reading here.