On September 14, the FDA approved both Telix’s Pixclara, the first FET-PET agent for glioma imaging, and Curium’s Bexlutry, Curium’s first-ever approved radioligand therapy. Neither is a PSMA product, but both show the same pattern: companies built on one PSMA-targeted product are actively diversifying into adjacent diagnostic and therapeutic indications. That expansion landed the same week GE HealthCare moved toward a roughly $1 billion acquisition of PET radiopharmaceutical manufacturer Sofie Biosciences — a reminder that platform breadth means little without secured production and supply behind it.

GE HealthCare is in advanced talks to acquire Sofie Biosciences for about $1 billion, the Financial Times reported September 13 via Reuters, with an announcement possibly coming within days. Sofie makes the radioactive chemicals used in PET cancer scans, and the deal would be GE HealthCare’s second major acquisition since its 2024 split from General Electric. Neither company has confirmed terms, but the strategic logic is clear: owning radiopharmaceutical manufacturing turns single-scan sales into a recurring revenue stream, and it gives GE HealthCare more control over the supply chain feeding its imaging equipment business at a moment when several competitors are making similar bets.

A JNM study of 63 men with PI-RADS 2-3 mpMRI findings (the FUPERMAN study) found that PSMA PET/CT-targeted biopsy improved detection of clinically significant prostate cancer compared with systematic biopsy alone in men whose conventional MRI was negative or equivocal, and explored dynamic total-body PET parameters as additional predictors — useful evidence for programs deciding when PSMA PET adds value ahead of a first biopsy.

A separate JNM analysis documented real-world disparities in PSMA PET/CT and 177Lu-PSMA therapy access between centers in Brazil and Europe, a reminder that regulatory approvals and reimbursement wins in the U.S. and EU don’t automatically translate into equitable global access to the same technology.

A third JNM study found that adding 18F-FDG PET to 68Ga-PSMA-11 PET before 177Lu-PSMA-617 therapy improved prognostic accuracy in metastatic castration-resistant prostate cancer, helping identify which patients are most likely to benefit from radioligand therapy before treatment begins.

Curium announced FDA approval of Bexlutry (lutetium Lu 177 dotatate) for SSTR-positive gastroenteropancreatic neuroendocrine tumors on September 14 — its first FDA-approved radioligand therapy, arriving via the 505(b)(2) pathway using Lutathera as the reference product, and coming just weeks after Curium’s agreement to acquire Lantheus in a deal worth up to $8 billion.

The FDA also approved Telix’s Pixclara (18F-FET) on September 14, the first FET-PET imaging agent approved for glioma, giving physicians a new tool to differentiate recurrent or progressive brain cancer from treatment-related change — and giving Telix an approved product line outside its core PSMA-targeted prostate imaging business ahead of its September 22 R&D Day.