Lantheus Holdings, Inc. (LNTH), an established leader in the development, manufacture, and commercialization of diagnostic medical imaging agents and products that assist clinicians in the diagnosis and treatment of cardiovascular and other diseases., announced the U.S. Food and Drug Administration (FDA) approval for PYLARIFY, an F 18-labeled prostate-specific membrane antigen (PSMA) specified positron emission tomography (PET) imaging agent, used to find potential metastasis or recurrence of prostate cancer.
Lantheus Holdings Inc. (LNTH) shares were rising 13.79% to trade at $19.51 in premarket at last check. LNTH stock lost -3.65% to close at $19.51. Shares of the company fluctuated between $19.301 and $20.48 throughout the day. LNTH shares have risen by 41.27% over the last 12 months, and they have moved down by -6.29% in the past week.
PYLARIFY has pioneered and is the only commercially available approved PSMA PET imaging agent for prostate cancer. The product is anticipated to be rapidly available in areas inclusive of the mid-Atlantic and southern space and availability may expand over the next six months with an increase in availability through the U.S. expected by the end of the year.
Identification of potential metastatic disorder in men considering initial definitive therapy is significant to optimize treatment planning and to halt inefficacious interventions. Male patients with prostate cancer who go through initial curative management, a maximum of 50% can experience recurrence of their disease within the first decade of their treatment.
Recurrent disease is may be discovered by increase in serum prostate-specific antigen (PSA) levels; however conventional imaging, especially at reduced PSA levels, is not able to discover the location and extent of the illness in most of the cases.
PYLARIFY was manufactured to specifically target PSMA, a protein that is overexpressed on the surface exceeding 90% of primary and metastatic prostate cancer cells. PYLARIFY attaches itself to the target, allowing the reader of the PET scan to discover and find the disease. Cyclotron generation of F 18 offers high batch capacity and high image resolution, and F 18’s 110-minute half-life grants wide segment distribution.
Approval for PYLARIFY by the U.S. Food and Drug Administration (FDA) has surged shareholder interest for the company, with LNTH stock price rising immensely at last check.