On Target · Issue 7Week Ending September 4, 2026

Three Publications Refine How Much Lutetium Is Enough

PSMA PET & Theranostics IntelligenceDosing Strategy16 primary sources

Diana’s opening noteThis week didn’t hand us a single blockbuster trial readout, and that’s fine by me. What it handed us instead was three recent publications all circling the same question I get asked constantly: how much lutetium is actually enough? Add a permanent Chair at Telix and fresh capital for two smaller players, and you have a sector that’s maturing on the business side as fast as the science.

Editor’s Spotlight

This week’s signal isn’t one trial readout, it’s the sector’s plumbing maturing on two fronts at once. Telix installs a permanent Chair, Ratio Therapeutics and Radiopharm Theranostics both land fresh capital, and Curium stakes its manufacturing scale on becoming a genuine Pluvicto rival. Meanwhile three new studies converge on the same practical question: how much lutetium is actually enough, and does the specific ligand matter?

Story of the Week

Curium is positioning itself as a real challenger to Pluvicto, arguing that its in-house lutetium manufacturing and distribution network can deliver the supply-chain resiliency the RLT field currently lacks. Lantheus had already shelved its own PSMA-directed filing before agreeing to merge with Curium in an up-to-$8 billion transaction, leaving Curium as the best-positioned company to launch a direct rival to Pluvicto. Curium says it will lean on decades of radiopharmaceutical manufacturing experience, in-house lutetium production lines, and established nuclear medicine relationships as it heads toward an FDA filing for its own 177Lu-PSMA-I&T therapy.

Clinical News

A newly published Phase 2 protocol will randomize 120 mCRPC patients 2:1 to a dose-intensified induction-then-maintenance regimen versus standard every-6-week dosing of 177Lu-PSMA-597, with a 90%-or-greater PSA decline as the primary endpoint (OPTIMAL-PSMA).

A RESIST-PC Phase 2 dosimetry substudy comparing 6.0 and 7.4 GBq cycles of 177Lu-PSMA-617 found no significant difference in kidney, salivary gland, or liver absorbed dose between arms, though tumor dose varied widely on an inter- and intrapatient level regardless of injected activity. Previously discussed in Issue 3; revisited here for the normal-organ dose finding.

A propensity-matched real-world analysis of 140 mCRPC patients found no statistically significant overall survival difference between 177Lu-PSMA-617 and 177Lu-PSMA-I&T, despite higher cumulative administered activity and better PSA response rates with 617 — a reminder that more activity doesn’t automatically translate to a better outcome. Published July 2; flagged here as slightly older than our usual window but not previously covered in this newsletter.

Business & Industry Intelligence

Ratio Therapeutics closed a $70 million Series C on July 31, with participation from Bristol Myers Squibb, Eli Lilly, and Catalio Capital Management, bringing total capital raised past $240 million. The funds advance Ratio’s Ac-225 ATLAS study and a next-generation radioligand candidate toward the clinic.

Radiopharm Theranostics will hold an extraordinary general meeting on or about September 11 seeking shareholder approval for a combined US$4.1 million registered direct offering and up to A$12.7 million in Australian placement and share purchase plan proceeds, earmarked chiefly for the company’s planned RAD101 registrational study.

Telix Pharmaceuticals named David Gill as Chair of the Board, effective September 1, succeeding Dr. Mark Nelson, who remains on the board as a Non-Executive Director. Gill joined Telix as a director in May as part of planned board succession and brings more than 35 years of biopharmaceutical and radiopharmaceutical leadership experience.

Practice insightDon’t assume higher activity or a specific ligand automatically means a better outcome.This week’s dosimetry and real-world data both point the same direction: organ doses stay in a tolerable range across activity levels, and survival doesn’t clearly favor one PSMA ligand over another. Programs comparing agents or evaluating dose-intensified protocols should consider ligand characteristics, treatment intensity, toxicity and logistics together rather than assuming that higher administered activity or a deeper biochemical response establishes superior ligand efficacy.

Clinical Trials to Watch

OPTIMAL-PSMA / Academic-sponsored — Phase 2, 120-patient, 2:1 randomized trial of dose-intensified vs. standard 177Lu-PSMA-597 dosing; protocol published July 30.

RAD101 / Radiopharm Theranostics — Phase 3 registrational trial targeted for Q4 2026, pending the September 11 shareholder vote and FDA alignment on trial design.

AcTFirst / Novartis — Phase 3 trial of 225Ac-PSMA-617 as frontline therapy in mCRPC, actively enrolling.

PSMAcTION / Novartis — Phase 2/3 trial of 225Ac-PSMA-617 in patients who progressed on prior PSMA-targeted therapy, actively enrolling.

Industry Movers & News in Brief

Novartis reported Pluvicto revenue of $1.3 billion for the first half of 2026, up more than 50% year-over-year.

Radiopharm’s RAD101 imaging agent hit 93% concordance with MRI in a Phase 2b brain metastases trial, clearing the way for the planned Phase 3 study.

The University of Missouri Research Reactor remains the only end-to-end U.S. producer of lutetium-177, a supply constraint shaping how Curium, Novartis, and every other RLT developer plans capacity.

Upcoming events: Radiopharm Theranostics EGM September 11, shareholder vote on combined financing package; ASTRO 2026 Annual Meeting September 26–30, Boston, MA; EANM’26 Annual Congress October 17–21, Vienna, Austria; and the SNMMI Theranostics Conference November 4–7, Bethesda, MD.

Diana’s takeThe leadership and financing moves matter more than any single trial this week — Telix formalizing its board, Ratio and Radiopharm both funded, Curium betting its manufacturing scale can win physician trust. But the real story is dosing: three recent publications this week say the field still doesn’t know the “right” amount of lutetium. Programs should treat activity level and ligand choice as open questions, not settled ones, until more data lands.

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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This newsletter is for informational and educational purposes only and does not constitute medical, legal, investment, or reimbursement advice. Readers should consult their own professional advisors for specific guidance.