Lantheus Holdings Inc.’s (LNTH) New Drug Application seeking approval for a new formulation of its F 18 PSMA (prostate-specific membrane antigen) imaging agent awaits the FDA decision on March 6, 2026.The company already markets FDA-approved Pylarify (piflufolastat F 18) injection, a PSMA-targeted PET imaging agent. It enables visualization of lymph nodes, bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer. The proposed new formulation optimizes the manufacturing process and is expected to increase batch size by roughly 50%, allowing Lantheus to treat substantially more patients while maintaining the same standards of Pylarify. The new formulation increases the radioactive concentration of the agent and has the potential to expand patient access in new geographic locations, according to the company.LNTH closed Tuesday’s (Feb.24, 2026) trading at $73.61, up 0.26%.