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BEDFORD, Mass. - Lantheus Holdings, Inc. (NASDAQ:LNTH), a $5 billion market cap healthcare company with strong financial metrics according to InvestingPro data, announced Wednesday that the U.S. Food and Drug Administration has accepted a New Drug Application for a new formulation of its F 18 PSMA imaging agent, with a PDUFA date set for March 6, 2026.
The application, filed by Lantheus affiliate Aphelion, aims to introduce a formulation that could increase batch production by approximately 50% compared to the company’s current PSMA PET imaging agent, PYLARIFY.
According to the company, the new formulation increases the radioactive concentration of the agent while maintaining the same diagnostic performance. If approved, Lantheus expects it will enhance supply resilience and potentially expand access to PSMA PET imaging for prostate cancer patients in new geographic locations.
"This formulation is a natural next step in our commitment to advancing PSMA imaging," said Brian Markison, CEO of Lantheus, in the press release statement.
PYLARIFY, Lantheus’ current market-leading PSMA PET imaging agent, has been used in over 500,000 scans across 48 states, Puerto Rico and Washington, D.C., according to company data. The diagnostic tool is indicated for PET imaging of PSMA-positive lesions in men with prostate cancer who have suspected metastasis or recurrence.
Prostate cancer remains the second most frequently diagnosed cancer among men in the U.S., with an estimated 315,000 new cases and more than 35,000 deaths projected for 2025, based on American Cancer Society data cited in the announcement.
The new formulation application comes as part of Lantheus’ strategy to address growing demand for prostate cancer diagnostics. The company stated that the optimized manufacturing process would allow it to serve more patients while maintaining existing quality standards.
In other recent news, Lantheus Holdings reported its first-quarter 2025 earnings, which fell short of analyst expectations. The company announced earnings per share of $1.53, missing the anticipated $1.64, and reported revenue of $372.8 million, below the forecasted $377.79 million. This underperformance led to a decline in the company’s stock in pre-market trading. Additionally, Truist Securities adjusted its outlook on Lantheus by lowering the price target to $117 from the previous $127, while maintaining a Buy recommendation. This revision was prompted by a slight miss in PyLuminate sales during the quarter. Truist analysts highlighted that similar past performances have often resulted in market overreactions, suggesting potential buying opportunities after the stock’s significant sell-off. They also noted that the current stock price might not accurately reflect Lantheus’ growth potential. These developments indicate a challenging quarter for Lantheus, with analysts still showing confidence in the company’s future prospects.
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