- The injection is indicated for imaging certain lesions in men with prostate cancer, the second most common form of cancer affecting men in the U.S.
- The new formulation has the same diagnostic properties and is expected to offer similar safety and effectiveness as formerly approved Pylarify.
- The company noted that the new formulation supports more efficient manufacturing and distribution which are expected to increase batch sizes, improving supply flexibility.
Shares of Lantheus Holdings, Inc. (LNTH) rose as much as 5% after hours on Friday after the company announced that the U.S. Food and Drug Administration has approved its PYLARIFY TruVu injection.
The injection is indicated for imaging certain lesions in men with prostate cancer, the second most common form of cancer affecting men in the U.S. It is now expected to be commercially available in the fourth quarter of 2026.
About The Newly Approved Injection
PYLARIFY TruVu is a new formulation of the company’s F 18 prostate-specific membrane antigen-targeted PET imaging agent. The new formulation has the same diagnostic properties and is expected to offer similar safety and effectiveness as formerly approved Pylarify.
“The availability of PYLARIFY TruVu addresses a key need identified by clinicians – greater access to our market-leading formulation,” CEO Mary Anne Heino said. The company also noted that the new formulation supports more efficient manufacturing and distribution which are expected to increase batch sizes, improving supply flexibility.
Lantheus said that the new injection would be rolled out in a way that it allows customers to transition from Pylarify to the new formulation with minimal disruption.
Pylarify was approved in May 2021 and more than 760,000 people with prostate cancer have received scans with it since, the company noted.
How Did Stocktwits Users React?
On Stocktwits, retail sentiment around LNTH rose from ‘bearish’ to ‘neutral’ territory over the past 24 hours, while message volume increased from ‘low’ to ‘normal’ levels.
LNTH stock has declined 28% over the past 12 months.
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