On Target Newsletter on PSMA & PET Theranostics Intelligence
Commercial Momentum and Diagnostic Evidence Move Together

On Target · Issue 15•Week Ending October 30, 2026

Commercial Momentum and Diagnostic Evidence Move Together

PSMA PET & Theranostics IntelligenceReal-World Evidence12 primary sources

Diana’s opening noteThis week gave us three threads worth following at once. Novartis posted another quarter of sharp Pluvicto growth alongside broader FDA and China approvals, a large German cohort handed PSMA PET staging the kind of real-world survival evidence that payer and referral conversations are built on, and ESMO 2026 in Madrid produced both durable alpha-emitter data and early resistance-biology findings worth planning around.

Editor’s Spotlight

Novartis reported Q3 2026 Pluvicto net sales of $674 million, up 20% (nine-month sales up 42% to $1.967 billion), with the FDA and China’s NMPA both clearing Pluvicto across all stages of PSMA-positive metastatic prostate cancer. The same week, a 6,999-patient German cohort found PSMA PET/CT staging associated with significantly longer overall survival (HR 0.54), cancer-specific survival (HR 0.37), and time to biochemical recurrence (HR 0.51; all P<0.001), with the clearest benefit in high-risk patients treated with radiotherapy. Commercial momentum and real-world diagnostic evidence are moving in the same direction.

Story of the Week

Novartis reported Q3 2026 Pluvicto net sales of $674 million, up 20% year over year, with nine-month sales up 42% to $1.967 billion. The quarter also brought FDA and China NMPA approvals of Pluvicto in combination with an androgen receptor pathway inhibitor, extending its label across all stages of PSMA-positive metastatic prostate cancer — from metastatic hormone-sensitive disease through castration-resistant disease. Novartis also signed an exclusive global licensing deal with BoomRay Pharmaceuticals for an undisclosed preclinical radioligand asset, and flagged radioligand therapy as one of three platforms it is prioritizing for new manufacturing capacity.

Clinical News

Precede Biosciences presented ESMO 2026 plasma epigenomic profiling data from 57 mCRPC patients treated with 177Lu-PSMA-617, including 17 with paired baseline-and-progression samples. Predicted PSMA expression declined in 11 of those 17 patients at progression, alongside declines in other therapeutic targets (TROP2, SEZ6, CEACAM5, DLL3) — early evidence that target-loss resistance is detectable noninvasively from a single 1 mL plasma draw, and a case for sequencing strategies that look beyond PSMA alone.

AdvanCell reported updated Phase I TheraPb data at ESMO 2026 showing 80% of patients had a PSA decline of at least 50% at the recommended doses of its lead-212 PSMA alpha therapy ADVC001, with median radiographic progression-free survival of 11.2 months and no new safety signals across 22 patients followed a median of 14.1 months.

Perspective Therapeutics presented updated interim data at ESMO 2026 for its lead-212 therapy VMT-alpha-NET in advanced SSTR2-expressing neuroendocrine tumors, reporting disease control rates of 89% and 95% across two dose cohorts, 72% progression-free survival at 18 months, and no dose-limiting toxicities.

Business & Industry Intelligence

Novartis’s Q3 2026 Pluvicto growth came alongside broader FDA and China NMPA approvals and a new radioligand-therapy licensing deal with BoomRay Pharmaceuticals — see Story of the Week for the full figures.

Telix shareholders will vote December 1, 2026 on its merger with Isotope Technologies Munich, which carries $1.65 billion in upfront consideration plus up to $700 million in contingent payments.

Telix’s isotope unit ARTMS now holds contracts for 50 QUANTM Irradiation Systems, expanding global capacity to produce the medical isotopes radiopharmaceutical programs depend on.

Practice insightResistance biology is catching up with PSMA-targeted therapy.Precede Biosciences’ finding that predicted PSMA expression declined in 11 of 17 paired 177Lu-PSMA-617 patients at progression is a reminder to plan for target-loss escalation pathways, not just initial PSMA PET eligibility, when counseling patients starting radioligand therapy — and to track the AdvanCell and Perspective alpha-emitter readouts, plus UCLA’s RE-LuPSMA retreatment data, as inputs to 2027 therapy-line planning.

Clinical Trials to Watch

TLX591-Tx / Telix, ProstACT Global Phase 3 — US Part 2 IND amendment being finalized; cleared to proceed in China and Japan.

TLX597-Tx / Telix, OPTIMAL-PSMA Phase 2 — enrollment complete at 120 patients; data readout expected 1H 2027.

TLX250-Tx / Telix, LUTEON pivotal trial — 177Lu girentuximab in clear cell renal cell carcinoma continues enrolling.

BiPASS / Telix, Phase 3 — 68Ga-PSMA-11 PET plus MRI for pre-biopsy detection; 350-patient enrollment complete, FDA Fast Track granted.

Industry Movers & News in Brief

United Theranostics named Amber Woodward-Smith Chief Financial Officer, tasking her with supporting the radiopharmaceutical network’s planned expansion into outpatient practices across all 50 states.

Telix completed Phase 3 enrollment for Illuccix in Japan, where a Conditional Approval is now under PMDA review.

UCLA’s RE-LuPSMA trial reported interim safety data at ESMO 2026: of 19 retreated patients, 2 serious treatment-related anemia events occurred and the predefined 5-event stopping threshold for serious treatment-related AEs was not met.

Upcoming events: the SNMMI Theranostics Conference Nov. 5–7, 2026, Bethesda, MD; RSNA 2026 Nov. 29–Dec. 3, 2026, Chicago, IL; SUO 2026 Annual Meeting Dec. 2–4, 2026, San Diego, CA; and ASCO GU 2027 Feb. 11–13, 2027, San Francisco, CA.

Diana’s takeThe most consequential thing this week isn’t a single trial readout — it’s that the diagnostic case for PSMA PET staging (the Dresden cohort), the commercial case for radioligand therapy (Novartis’s Pluvicto numbers), and the resistance-planning case (Precede’s target-loss data) all landed in the same week. Programs should be citing the staging data in payer and referral conversations now and should start building target-loss and retreatment pathways into their therapy-line planning rather than waiting for a prospective trial to catch up.

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.

If we missed your news or data requires correction, the author can be reached at info@mismedical.com.

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