On Target · Issue 5•Week Ending August 21, 2026
PSMA PET Beats MRI for Post-Focal-Therapy Surveillance
PSMA PET & Theranostics IntelligenceFocal Therapy13 primary sources
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.
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.
Upcoming events: ASTRO 2026 September 26–30 in Boston; EANM’26 October 17–21 in Vienna; ESMO Congress 2026 October 23–27 in Madrid; and the SNMMI Theranostics Conference November 4–7 in Bethesda, Maryland.
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.

