Theranostic Newsletter | 11.2025 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 📰

Radiopharm Theranostics Announces 50 Percent Enrollment in Phase 2b Trial of RAD101 Imaging in Brain Metastases

Radiopharm Theranostics has reached 50 percent enrollment in its Phase 2b trial evaluating RAD101, a FASN-targeted imaging agent designed to distinguish tumor recurrence from radiation necrosis in patients with brain metastases. Early patient data show strong, selective tumor uptake and clearer metabolic characterization than MRI, reinforcing RAD101’s promise in an area with a major unmet clinical need. If these results continue, the program is expected to advance toward a global Phase 3 registrational trial. This milestone highlights the expanding role of theranostic imaging in improving diagnostic confidence for complex intracranial disease.
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Facet Life Sciences and XCancer Announce Strategic Partnership to Advance Theranostic Clinical Trials

Facet Life Sciences and XCancer have formed a new partnership to accelerate the development and approval of cutting-edge radiopharmaceutical therapies. By combining Facet’s regulatory and drug development expertise with XCancer’s global theranostic clinical trial network, the collaboration will streamline how sponsors advance both diagnostic and therapeutic radiopharmaceuticals. The partnership strengthens the theranostic ecosystem by reducing barriers, speeding clinical trial activation, and expanding patient access to precision oncology.
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ITM Receives U.S. FDA Fast Track Designation for ITM-94 as a Diagnostic Agent for Clear Cell Renal Cell Carcinoma

ITM has received FDA Fast Track designation for ITM-94, a gallium-68 PET agent designed to improve the noninvasive detection of clear cell renal cell carcinoma. ITM-94 forms a theranostic pair with the therapeutic agent ITM-91, offering a coordinated diagnostic and therapeutic approach targeting CAIX, a key protein driving tumor growth and metastasis. Early clinical data suggest the tracer may outperform standard CT and MRI for classifying indeterminate renal masses, with strong imaging contrast and favorable tolerability. This milestone underscores growing momentum in theranostic development for kidney cancer.
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WSAUA 2025: Impact of PSA Doubling Time and Absolute PSA on PSMA PET Positivity in Post-Prostatectomy Biochemical Recurrence

A Mayo Clinic analysis of 405 patients shows that both absolute PSA levels and PSA doubling time significantly influence PSMA PET positivity in men with biochemical recurrence after prostatectomy. Detection rates increased sharply with higher PSA values, but the strongest predictor was a rapid PSA doubling time, which markedly boosted PSMA PET sensitivity even at low PSA levels. These findings reinforce PSA kinetics as a crucial tool for optimizing when to order PSMA PET and improving diagnostic yield in theranostic pathways for recurrent prostate cancer.
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Rapid Growth of Radiopharmaceutical Therapy Highlights Need for Expertise

SNMMI has released a new position paper calling for standardized education, training, and credentialing to support the safe expansion of radiopharmaceutical therapy. As investment in theranostic agents accelerates and global demand rises, the Society warns that proper expertise in dosimetry, radiation safety, and patient management is essential to maintain high-quality care. The paper also highlights SNMMI’s growing role in training, accreditation, and international collaboration to support the future of theranostics worldwide.
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Theranostics Market to Reach $12.5 Billion by 2034

A new market analysis projects that the global theranostics sector will more than double, from $5.3 billion in 2024 to $12.5 billion by 2034, driven by the rapid adoption of precision radiopharmaceuticals and companion diagnostics. Oncology continues to dominate the space, while emerging applications in neurology and cardiovascular disease signal broader clinical impact ahead. The report highlights strong growth in North America and accelerating investment across Asia-Pacific, fueled by advances in molecular imaging, radiolabeled drugs, and AI-enabled diagnostic tools. These trends underscore the expanding role of theranostic approaches in shaping the future of personalized medicine.
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OPALESCENCE Trial Published in EJNMMI: Confirms Theranostic Potential of TLX250-CDx in Breast Cancer

Final Phase 2 data from the OPALESCENCE trial show that TLX250-CDx, a CAIX-targeted immuno-PET agent, achieves high sensitivity and strong tumor targeting in women with metastatic triple-negative breast cancer. The tracer detected all brain metastases in the study, far outperforming FDG PET, and demonstrated excellent lesion recognition across breast, skin, adrenal, nodal, and bone sites. With no safety concerns reported, the findings reinforce TLX250-CDx as a promising theranostic tool that could enable CAIX-targeted therapies for patients with limited treatment options.
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FDA Greenlights Phase 1 Trial of Theranostic Radiopharmaceutical for mCRPC

The FDA has cleared the IND application for ART-101, a next-generation PSMA-targeting small molecule designed for both imaging and treatment of metastatic castration-resistant prostate cancer. Preclinical data show higher tumor uptake, longer retention, and reduced off-target activity compared with currently approved PSMA agents, strengthening its potential as a safer and more effective theranostic option. The phase 1 trial will evaluate ART-101’s compatibility with multiple therapeutic isotopes, including actinium-225 and lutetium-177, marking an important step for expanding radiopharmaceutical innovation in hard-to-treat cancers.
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