By Puyaan Singh and Sahil Pandey
March 6 (Reuters) – The U.S. Food and Drug Administration on Friday approved a new formulation of Lantheus Holdings’ prostate cancer imaging agent, aimed at improving scanning access through increased production capacity.
Shares of the company were up about 4% in extended trading.
The imaging agent, Pylarify, targets prostate-specific membrane antigen (PSMA), a protein that is commonly elevated in prostate cancer cells and used to detect metastatic or recurrent disease in patients.
The new version, called Pylarify TruVu, keeps the same diagnostic performance but is built to handle higher radioactive concentrations, which allows larger batches and more efficient distribution, the company said.
Lantheus said the new formulation is expected to increase batch size by about 50%, improve margins and help suppliers reach geographic areas where clinics do not yet have access to PSMA PET scans.
Truist analyst Richard Newitter said the approval is an “important catalyst” that raises the analysts’ confidence in a revenue and profit re-acceleration beginning in the second half of 2026.
A PSMA PET scan uses a small dose of radioactive material that binds to prostate cancer cells, helping doctors detect even tiny signs that the cancer has returned or spread.
The company expects to launch Pylarify TruVu in the fourth quarter of 2026 with a phased rollout.
Lantheus told Reuters that it timed the launch to coincide with new reimbursement codes taking effect on October 1, which it said would provide clarity for providers.
Pylarify has been shown to achieve an 86% median true-positive rate in identifying recurrent prostate cancer, according to studies evaluated by independent readers.
Prostate cancer is among the most frequently diagnosed cancers in the U.S. male population and a leading cause of cancer-related deaths worldwide.
In 2025, about 313,780 men were diagnosed with prostate cancer in the United States, and 35,770 died from the disease last year, according to the National Institutes of Health.
(Reporting by Sahil Pandey, Puyaan Singh and Kamal Choudhury in Bengaluru; Editing by Sahal Muhammed and Alan Barona)
