Diana’s Opening Note

This week gave us a nice pairing: Telix’s numbers showed the radiopharma business model working end to end, and a UCLA study gave us fresh evidence for a question I get asked constantly – what do you do about surveillance after focal therapy? I’ve included both, plus the full PSMAddition dataset now published in The Lancet, which is worth reading even though the approval it supports is a few weeks old. As always, if I missed something or got a detail wrong, tell me.

Editor’s Spotlight

Telix’s half-year report and a new UCLA study landed the same week and pointed the same direction. Telix posted 22% revenue growth and a 146% jump in adjusted EBITDA on a $40 million Regeneron payment, while its lead prostate therapy, TLX591-Tx, cleared an FDA gate to Part 2 of a pivotal U.S. trial. Days earlier, a 112-patient UCLA study found PSMA PET/CT detects recurrence after focal therapy with 85% sensitivity versus 82% for MRI. Commercial strength and imaging evidence are reinforcing each other this quarter.

Story of the Week

Telix’s H1 2026 results showed group revenue of $477 million, up 22% year over year, and adjusted EBITDA of $52 million, up 146%, aided by a $40 million payment from its Regeneron radiopharmaceutical collaboration. The company also disclosed that ProstACT Global’s Part 1 lead-in for TLX591-Tx, its lutetium-177 prostate cancer therapy, met safety and dosimetry objectives, and that the FDA confirmed the data are sufficient to advance to Part 2 in the U.S. Telix completed a $600 million convertible bond refinancing and opened a new at-the-market equity facility with Morgan Stanley and William Blair the same day.

Clinical News

A 112-patient UCLA study published August 20 in JNM found gallium-68 PSMA-11 PET/CT detected recurrence after focal therapy with 85% per-patient sensitivity versus 82% for multiparametric MRI, identifying intraprostatic recurrence in 82% of patients, pelvic nodal disease in 15%, and distant metastases in 9%. No standardized criteria for biochemical recurrence after focal therapy exist yet, the authors noted, but the study argues PSMA PET/CT should become the default surveillance tool.

The Phase 3 PSMAddition trial’s full results published August 6 in The Lancet, confirming that adding 177Lu-PSMA-617 to standard hormone therapy cut the risk of progression or death by 28% in more than 1,100 men with PSMA-positive metastatic hormone-sensitive prostate cancer. The data underlie the FDA’s late-July approval of Pluvicto in this earlier setting.

Radiopharm Theranostics said its safety monitoring committee recommended advancing 177Lu-RAD202 to the 180mCi dose level in the Phase 1 HEAT trial, a HER2-targeted radioligand therapy for advanced solid tumors, citing a favorable safety profile through the prior 130mCi cohort.

Business & Industry Intelligence

Defence Therapeutics named Dr. Ryan Simms, a former Fusion Pharmaceuticals R&D leader, Chief Operating Officer and Head of Radiopharmaceutical Programs, adding radioligand-conjugate manufacturing and clinical development expertise as the company builds out its RDC pipeline.

Curium’s acquisition of Lantheus remains subject to shareholder and regulatory approval, with both companies still targeting a first-half-2027 close of the up-to-$8 billion deal.

Radiopharm Theranostics scheduled an FDA End-of-Phase-2 meeting for October 1 to align on a pivotal Phase 3 trial design for RAD101, its brain metastasis imaging agent.

Practice Insights

Update post-focal-therapy surveillance to PSMA PET/CT. With PSMA PET/CT now shown to outperform MRI for detecting recurrence after focal therapy, programs offering HIFU, cryoablation, or laser ablation should update surveillance protocols and payer conversations accordingly and confirm PET capacity can absorb the added scan volume.

Clinical Trials to Watch

ProstACT Global / Telix — TLX591-Tx Part 1 lead-in met safety and dosimetry goals; FDA cleared advance to Part 2 in the U.S.

HEAT / Radiopharm Theranostics — 177Lu-RAD202 dose-escalates to 180mCi Cohort 4 in HER2-positive solid tumors after DSMC clearance.

PSMAcTION / Novartis — Phase 2/3 trial of 225Ac-PSMA-617 vs. standard of care enrolling in mCRPC patients who progressed on Lu-PSMA therapy.

AcTFirst / Novartis — Phase 3 trial of 225Ac-PSMA-617 enrolling in frontline mCRPC, post-ARPI but pre-Pluvicto and chemotherapy.

Industry Movers / News in Brief

Defence Therapeutics named Dr. Ryan Simms Chief Operating Officer and Head of Radiopharmaceutical Programs, adding radioligand-conjugate manufacturing expertise as it builds out its RDC pipeline.

ASTRO 2026 is scheduled for Sept. 26-30 in Boston; EANM’26 for Oct. 17-21 in Vienna; ESMO Congress 2026 for Oct. 23-27 in Madrid; and the SNMMI Theranostics Conference for Nov. 4-7 in Bethesda, Maryland.

Diana’s Take

Telix’s quarter previews where the sector is heading: diversified revenue, a big-pharma partner paying for platform access, and a therapeutics pipeline advancing on the FDA’s own timeline. Pair that with the UCLA data on PSMA PET/CT after focal therapy, and the message for programs is the same as it’s been all year: imaging and therapy volumes are both about to grow. Make sure your PET capacity and surveillance protocols are ready for both.

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.

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