Shares of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions firm Lantheus Holdings (NASDAQ: LNTH) are surging premarket after the US Food and Drug Administration (FDA) approved PYLARIFY.
PYLARIFY is an imaging agent used to identify suspected metastasis or recurrence of prostate cancer.
According to Lantheus, PYLARIFY is the first and only commercially available approved PSMA PET imaging agent for prostate cancer.
Mary Anne Heino, President and CEO of Lantheus, described the FDA approval as a “significant milestone,” stating that PYLARIFY “represents a paradigm shift in the identification and management of patients with suspected metastasis or recurrent prostate cancer, providing more accurate and earlier detection of disease than conventional imaging.”
PYLARIFY was developed to target PSMA, a protein overexpressed on the surface of more than 90% of primary and metastatic prostate cancer cells. PYLARIFY binds to the target, enabling the reader of the PET scan to detect and locate the disease.
The approval of PYLARIFY is based on data from two studies (OSPREY and CONDOR) designed to establish the safety and diagnostic performance across prostate cancer disease.
Lantheus Holdings share price has rallied premarket, up 23.27% at $24.05.
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