March 17 (Reuters) – Lantheus Holdings said on Tuesday that the U.S. health regulator has extended its review of the company’s diagnostic imaging kit by three months as it needs more time to review manufacturing-related information.
Shares of the Bedford-based company were down over 2% in extended trading.
Lantheus said the review extension is not related to efficacy or safety data, and the Food and Drug Administration will decide on approval for the diagnostic kit, LNTH-2501, by June 29.
LNTH-2501 is designed to help doctors find a type of cancer called neuroendocrine tumors, or NETs, using a PET scan — a type of medical imaging.
While the delay is a slight disappointment, “we are nevertheless relieved that the extension is not related to the clinical profile,” William Blair analyst Andy Hsieh said in a research note.
NETs are cancers that begin in hormone-producing cells found throughout the body, most often in the lungs, pancreas and digestive tract.
The condition is more common in adults than children, and the slow-growing subtype once known as carcinoid tumor affects about 4 in every 100,000 adults, while cases in young people remain so rare that reliable data are lacking, according to National Institutes of Health.
LNTH-2501 is a two-vial kit that lets radiopharmacies quickly mix the drug with gallium from their own generator to make the final injection.
Hsieh expects the kit to launch in the third quarter, noting that earlier forecasts already included a one-quarter buffer and estimates about $2 million in sales for the third quarter and $5 million for the fourth.
(Reporting by Kamal Choudhury in Bengaluru; Editing by Shailesh Kuber)
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