The U.S. Food and Drug Administration (FDA) has denied Lantheus' application for a new PET imaging agent, LNTH-2501, due to concerns about issues at a third-party manufacturing site. The company, based in Bedford, Massachusetts, originally aimed to launch the radioactive diagnostic kit for localizing neuroendocrine tumors by June 29, but now finds this timeline unfeasible following the FDA's feedback. Despite this setback, Lantheus remains confident in the product's potential and is working with the agency and their manufacturer to resolve the issues. Neuroendocrine tumors, which are rare, are characterized by both nerve and hormone-producing properties and are mostly found in the digestive tract or lungs. Following the FDA's decision, Lantheus' stock experienced a slight decline, though some analysts believe the setback is manageable and suggest buying the stock during dips.
Mon, 29 Jun 2026 05:56:56 GMT | Radiology Business