FDA Approves Lantheus Holdings' Imaging Agent For Prostate Cancer

(RTTNews) - Lantheus Holdings Inc.'s (LNTH) PYLARIFY injection, a prostate specific membrane antigen-targeted positron emission tomography imaging agent, has been approved by the FDA.

PYLARIFY is indicated for identification of suspected metastasis or recurrence of prostate cancer.

The product will be immediately available in parts of the mid-Atlantic and southern regions and its availability is expected to rapidly expand over the next six months with broad availability across the U.S. anticipated by year end, the company noted.

Prostate cancer is the second most common cancer in American men and over 3.1 million people are living with it today.

PYLARIFY will have to compete with Bracco's Axumin (fluciclovine F 18), which is already on the market and Telix Pharmaceuticals Ltd's PSMA-targeted prostate cancer PET diagnostic imaging agent Illuccix, which is under FDA review, with a decision expected in September of this year.

LNTH has traded in a range of $10.52 to $24.26 in the last 1 year. The stock closed Wednesday's trading at $19.51, down 3.65%.