Diana’s Opening Note
This week highlights two of the field’s largest radioligand franchises scaling into durable, multi-hundred-million-dollar quarterly businesses — Telix and Novartis’s Pluvicto — alongside capital continuing to flow into imaging capacity through GE HealthCare’s Care Alliance with Catholic Health. At the same time, peer-reviewed evidence is catching up on the operational side, sharpening how we select and monitor patients for Lu-PSMA therapy.
Editor’s Spotlight
The strongest signal is the convergence of commercial scale and clinical rigor. Telix posted $247 million in Q2 revenue, up 21% year-over-year, with the FDA confirming that Part 1 safety data for TLX591-Tx is sufficient to progress ProstACT Global Phase 3 into Part 2 in the U.S. Novartis’s Pluvicto grew 43% to $651 million in the same quarter. Meanwhile, a peer-reviewed ProstACT SELECT publication, a new PROFILE prognostic score, and new clonal hematopoiesis safety data all point to the same conclusion: as radioligand therapy volumes grow, formal patient-selection and safety-monitoring pathways matter as much as access to the therapy itself.
Story of the Week
Telix reported Q2 2026 group revenue of US$247 million, up 21% year-over-year, with Precision Medicine revenue up 30% year-over-year. During the quarter, the FDA confirmed that Part 1 safety data from the ProstACT Global Phase 3 study of TLX591-Tx is sufficient to enable progression of Part 2 in the U.S., and the FDA and Telix aligned on the Part 2 clinical trial protocol, statistical analysis plan, and ongoing safety monitoring plan. Telix also disclosed rapid enrollment of 338 patients in the BiPASS Phase 3 study evaluating pre-biopsy PSMA PET for initial prostate cancer diagnosis, and dosed the first patient in the Phase 3 LUTEON trial of TLX250-Tx for kidney cancer — broadening its theranostics platform beyond prostate.
Clinical News
A peer-reviewed ProstACT SELECT study published in Cancers confirmed that 68Ga-PSMA-PET imaging reliably identifies patients suited to TLX591-Tx radio-antibody-drug conjugate therapy, reporting a manageable and predictable safety profile and a median radiographic progression-free survival of 8.8 months in evaluable patients.
A new PROFILE prognostic score published in the Journal of Nuclear Medicine combines baseline FDG PET/CT and PSMA PET/CT findings with hemoglobin to help predict outcomes and screen eligibility for Lu-PSMA-617 therapy. The score was internally and externally validated.
A separate Journal of Nuclear Medicine study found clonal hematopoiesis to be highly prevalent and linked to greater hematologic toxicity in patients treated with 177Lu-PSMA-617, with expansion or emergence of DNA-damage-repair clones common during and after therapy.
Business & Industry Intelligence
GE HealthCare and Catholic Health announced a 10-year, approximately $500 million Care Alliance, bringing new MR, CT, and PET systems, expanded nuclear medicine capabilities, and cloud-based Imaging 360 radiology operations tools to more than 40 Catholic Health sites on Long Island.
Novartis reported Pluvicto sales grew 43% at constant currencies to $651 million in Q2 2026, with PSMAddition subgroup data presented at AUA showing a 58% reduction in the risk of PSA progression versus standard of care alone in PSMA-positive mHSPC.
Truist Financial raised its Lantheus price target to $125 from $115 ahead of the planned fourth-quarter 2026 commercial rollout of PYLARIFY TruVu.
Novartis confirmed it discontinued its mid-stage radioligand candidate 177Lu-NeoB for breast cancer and other solid tumors after early clinical data did not support advancement — a reminder that pipeline pruning continues even as Pluvicto scales.
Practice Insights
Build hematologic and prognostic screening into the Lu-PSMA pathway. Incorporate baseline hemoglobin and PSMA/FDG PET discordance into eligibility screening, and add structured blood-count monitoring for clonal hematopoiesis risk to routine follow-up for patients on Lu-PSMA therapy — not just imaging response. As referral volumes grow, formalizing this pathway now will keep monitoring rigorous rather than reactive.
Clinical Trials to Watch
ProstACT Global — the FDA confirmed Part 1 safety data for TLX591-Tx is sufficient to progress Phase 3 to Part 2 in the U.S., with the protocol and statistical plan aligned; the study continues enrolling in Australia, New Zealand, Canada, Turkiye, the U.K., Singapore, and South Korea, and has received approval to begin in China.
PSMAddition — subgroup data show Pluvicto plus standard of care achieved consistent radiographic progression-free survival benefit regardless of disease volume or presentation in PSMA-positive mHSPC.
BiPASS — Telix’s Phase 3 study achieved rapid enrollment of 338 patients evaluating pre-biopsy PSMA PET for initial prostate cancer diagnosis, intended to support U.S., European, and Australian regulatory submissions.
LUTEON — Telix dosed the first patient in this Phase 3 trial of TLX250-Tx, a CAIX-targeted radioligand, for relapsed or recurrent clear cell renal cell carcinoma.
Industry Movers / News in Brief
RadioMedix appointed former Lantheus CEO Brian A. Markison to its board of directors, adding four decades of oncology, diagnostics, and radiopharmaceutical leadership experience as the company executes its growth strategy.
ASTRO 2026 is scheduled for September 26-30 in Boston; EANM’26 for October 17-21 in Vienna; ESMO 2026 for October 23-27 in Madrid; and the SNMMI Theranostics Conference for November 4-8 in Bethesda.
Diana’s Take
This week shows the field’s two largest radioligand franchises scaling into durable, multi-hundred-million-dollar quarterly businesses, while peer-reviewed evidence is catching up on the operational side with better patient-selection tools and clearer hematologic safety signals. Programs that pair growth capital, like GE HealthCare’s Care Alliance, with disciplined patient selection and structured toxicity monitoring will be the ones that scale responsibly as volumes climb.
About the Author
Diana J. Errico is Director, Strategic Service Lines at Molecular Imaging Services. She focuses on helping healthcare organizations evaluate, implement, and grow advanced molecular imaging, PET/CT, PSMA PET, and theranostics programs through strategic planning, clinical workflow development, and operational support.
Outreach
If we missed your news or data requires correction, the author can be reached at info@mismedical.com.
#PSMAPET #Theranostics #MolecularImaging #ProstateCancer #NuclearMedicine #Radiopharmaceuticals #Urology #Oncology #HealthcareStrategy
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