On June 26, Lantheus disclosed a complete response letter for LNTH-2501, its gallium-68 edotreotide PET diagnostic kit for locating somatostatin-receptor-positive neuroendocrine tumors in adults and children. The FDA cited unresolved inspection conditions at the third-party facility that manufactures the drug product and could not approve by the June 29 PDUFA date. The agency raised no concerns about the clinical data, safety, or efficacy. CEO Mary Anne Heino said the feedback 'relates solely to our third-party manufacturer, and not to the clinical performance of the product.'
Aktis Oncology released first-in-human clinical imaging and dosimetry data on AKY-2519 ahead of ASCO 2026. AKY-2519 is a miniprotein radioconjugate — a small synthetic protein scaffold (akin to engineered peptide architecture) linked to a therapeutic radionuclide — targeting B7-H3, an antigen overexpressed in multiple solid tumors including metastatic castration-resistant prostate cancer (mCRPC) and non-small cell lung cancer. The Phase 1 data demonstrated robust tumor uptake and limited normal-tissue exposure across multiple B7-H3-expressing tumor types. Two ASCO 2026 poster presentations cover the imaging and dosimetry results. The FDA cleared the IND for AKY-2519 in March 2026; a Phase 1b clinical trial in mCRPC patients is ongoing, with a second Phase 1b in various B7-H3-expressing tumor types expected to initiate in H2 2026. AKY-2519 joins Novartis's Pluvicto (PSMA-617) and Lutathera (DOTATATE) in the small but growing class of peptide-related radioconjugates with first-in-human or commercial validation.