Lantheus won final FDA approval for BRAVNETSA (lutetium Lu 177 dotatate) on September 22, the first radioligand therapy cleared through FDA’s abbreviated new drug application pathway and determined bioequivalent to LUTATHERA for GEP-NETs. The approval lands as Curium works to close its acquisition of Lantheus, meaning the two merging companies now each hold an approved Lu-177 dotatate product for the same tumor type. It’s a preview of how fast this therapeutic class is consolidating, and a reminder that approval status can shift mid-deal.

Telix agreed to acquire Germany’s ITM Isotope Technologies Munich for $1.65 billion upfront in stock and assumed debt, plus up to $700 million in milestones tied to ITM’s lead radioligand, ITM-11. Telix’s board and holders of more than 90% of ITM shares have already approved the deal. It still requires a Telix shareholder vote in November and is expected to close by year-end. The acquisition adds ITM’s isotope manufacturing and distribution network to Telix’s pipeline and follows an August FDA Complete Response Letter on ITM-11 over manufacturing and third-party facility issues — clinical data was not in question.

A Mayo Clinic propensity-score analysis in JNM found no difference in early renal function decline between 177Lu-PSMA-617 and taxane-based chemotherapy in mCRPC. Over longer follow-up renal function declined in both groups, and patients with pre-existing chronic kidney disease fared worse after 177Lu-PSMA-617. The authors conclude renal concerns alone should not exclude otherwise eligible patients.

A JNM study linked ATM gene alterations to differential outcomes after 177Lu-PSMA-617 treatment in mCRPC, adding to the case for molecular profiling alongside PSMA PET when selecting and sequencing radioligand therapy candidates.

A Phase 1 dose-escalation study of the rapid-clearance radioligand 177Lu-P17-087 in five mCRPC patients tolerated activities up to 7.4 GBq per cycle with lower effective organ doses than its albumin-binding derivative, including one complete response.

Telix’s acquisition of ITM Isotope Technologies Munich creates a vertically integrated radiopharmaceutical manufacturer and is expected to close by year-end 2026.

Curium withdrew and refiled its antitrust notification for the Lantheus acquisition on September 17 and 21, restarting a 30-day HSR review that now expires October 21. Lantheus shareholders vote on the $102.50-per-share deal, plus a contingent value right worth up to $12.00 per share, on October 14.

Perspective Therapeutics signed a clinical collaboration and supply agreement with Merck to evaluate its alpha-emitting 212Pb-PSV359 alongside Keytruda in FAP-alpha-positive solid tumors, adding a checkpoint-inhibitor combination arm to its lead-212 platform.