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BEDFORD, Mass. - The U.S. Food and Drug Administration has established a Prescription Drug User Fee Act (PDUFA) target action date of March 29, 2026, for Lantheus Holdings, Inc.'s (NASDAQ:LNTH) LNTH-2501, according to a company press release issued Thursday. Lantheus, with a market capitalization of $3.8 billion and a P/E ratio of 14.88, has been profitable over the last twelve months with revenue of $1.52 billion.
LNTH-2501 (Gallium-68 edotreotide) is a diagnostic kit for preparing injections used with positron emission tomography (PET) imaging to locate somatostatin receptor-positive neuroendocrine tumors (NETs) in both adult and pediatric patients.
The product was submitted under the FDA's 505(b)(2) pathway, building on existing evidence for Ga-68 edotreotide from multiple published studies.
"LNTH-2501 has the potential to provide clinicians a reliable and accessible option for identifying and managing somatostatin receptor-positive neuroendocrine tumors," said Brian Markison, CEO of Lantheus, in the statement.
Neuroendocrine tumors are rare cancers that can develop throughout the body, with an estimated 170,000 people living with NETs in the United States. According to the release, up to 50% of NETs are initially misdiagnosed due to slow growth and non-specific symptoms, leading to delayed detection and treatment.
If approved, LNTH-2501 would expand Lantheus' oncology diagnostic portfolio and potentially complement the company's therapeutic candidate PNT2003 as part of a theranostic approach for NET patients.
The product is not currently approved by the FDA and is not yet available for sale in the United States.
In other recent news, Lantheus Holdings has announced that the U.S. Food and Drug Administration accepted its New Drug Application for MK-6240, a PET imaging agent intended for Alzheimer's diagnostics. This application has a target action date set for August 13, 2026. Meanwhile, Lantheus has entered into an exclusive licensing agreement with GE HealthCare for its prostate cancer diagnostic imaging agent, PYLARIFY, in Japan. GE HealthCare will take on the development, manufacturing, and commercialization of the agent in Japan.
However, Lantheus has faced some challenges as well. Goldman Sachs downgraded the company from Buy to Neutral, citing concerns about growth visibility and lowering its price target to $77.00. Similarly, Truist Securities downgraded the stock to Hold, reducing its price target to $63.00 due to concerns about PYLARIFY's performance. Leerink Partners also lowered its price target for Lantheus to $99.00, citing competitive headwinds affecting the Pylarify franchise. These developments highlight a mix of strategic moves and challenges for Lantheus in the current market landscape.
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