PSMA PET moved a step earlier in the diagnostic pathway this week, as Telix completed Phase 3 BiPASS enrollment and aligned with the FDA on a pre-biopsy NDA pathway, and previously published DEPROMP data, revisited in JNM this week, found PSMA PET changes management in 34% of biopsy-naive men. At the same time, the PSMA target itself is widening beyond radioligand therapy: China cleared InnoCare’s PSMA/STEAP1 bispecific antibody-drug conjugate for trials this week, while Lantheus set an October 14 vote on Curium’s $8 billion buyout.

Telix completed enrollment of 350 patients in its Phase 3 BiPASS trial on September 2 and has positively engaged the FDA on an NDA pathway that would bring reimbursed 68Ga-PSMA-PET into the pre-biopsy setting for the first time. If that pathway holds, PSMA PET moves from a staging and recurrence tool into a materially larger pre-biopsy screening population — a shift with direct implications for imaging capacity, referral pathways, and reimbursement modeling.

A four-institution JNM study matched 18F-DCFPyL PET parameters to histopathology, establishing SUV and lesion-uptake thresholds that separate malignant from benign prostate tissue — a step toward more objective, less reader-dependent interpretation, though the thresholds still need external validation before they change routine reporting.

The DEPROMP phase 2 trial, published in JNM in December 2025 and revisited in a letter to the editor this week, found PSMA PET/CT ahead of multiparametric MRI altered planned management in 34% of the 137 men with confirmed prostate cancer. The cohort was recruited between 2021 and 2023 from a single referral population, so it supports the BiPASS direction rather than independently confirming it.

InnoCare’s ICP-B381, a bispecific antibody-drug conjugate targeting both PSMA and STEAP1, received NMPA clearance to begin trials — an early-stage signal, not a validated therapy, but a sign the PSMA target is attracting approaches well beyond radioligand therapy.

Lantheus set an October 14 special meeting for shareholders to vote on Curium’s up to $8 billion acquisition, $102.50 per share plus up to $12.00 in contingent value rights, combining two of the sector’s largest manufacturing and distribution networks.

Norroy Bioscience received NMPA clearance on September 2 to begin a randomized Phase 3 study of 177Lu-NYM032 in PSMA-positive mCRPC patients — a new entrant into the crowded lutetium field.