Lantheus Says FDA Accepted NDA For A New Formulation Of PSMA PET Imaging Agent

(RTTNews) - Lantheus Holdings, Inc. (LNTH) Wednesday said the Food and Drug Administration (FDA) has accepted New Drug Application (NDA) for a new formulation of its prostrate cancer diagnostic imaging agent, Pylarify, filed by the company's affiliate, Aphelion.

The Prescription Drug User Fee Act (PDUFA) date, or the date on which a decision from the regulator is expected, is March 6, 2026.

This NDA acceptance builds on the success of Pylarify which has demonstrated superior diagnostic performance and considerable influence on clinical decision making.

"This new formulation optimizes the manufacturing process and is expected to increase batch size by nearly 50%, allowing Lantheus to serve significantly more patients while maintaining the same high standards that has made Pylarify the trusted choice for providers," the company said in a statement.