Lantheus to seek approval for new Alzheimer’s PET imaging agent in Q3
Radiopharmaceutical firm Lantheus said Wednesday it plans to seek approval for its new Alzheimer’s PET imaging agent in the third quarter of 2025.
The declaration comes with the North Billerica, Massachusetts-based drugmaker announcing positive results from two “pivotal” studies. Lantheus is currently testing MK-6240, a radiodiagnostic that targets tau protein tangles—a “key hallmark of several neurodegenerative diseases.”
The product has successfully met primary endpoints in two trials assessing sensitivity and specificity. Data from the experiments will support an upcoming New Drug Application with the FDA, expected by September.
“The clinical results of MK-6240 underscore our commitment to providing cutting-edge imaging solutions for Alzheimer’s disease that align with the latest scientific advancements,” CEO Brian Markison said in a statement April 30. “With MK-6240 successfully meeting its primary endpoints in both pivotal studies, we are moving closer to delivering this innovative radiodiagnostic to potentially support precise diagnoses and improve disease management.”
Lantheus acquired the imaging agent as part of its purchase of Cerveau Technologies Inc. in 2023. It sees MK-6240 as a potential tool to aid radiologists and other clinicians in the diagnosis, staging and monitoring of Alzheimer’s. Lantheus also believes the product complements its ß amyloid PET imaging agent, NAV-4694. The drug is currently in Phase 3 development and actively used in both academic- and industry-led therapeutic trials for Alzheimer’s.
“Together, these imaging agents, if approved, will further position Lantheus as the leader in radiopharmaceutical innovation, supporting the evolving diagnostic landscape for neurodegenerative conditions,” the company said Wednesday.
Lantheus cited recent research, which estimated that the U.S. Alzheimer’s disease radiodiagnostic market has the potential to reach over 400,000 scans and $1.5 billion in annual value by 2030. Currently, there are over 100 therapies in clinical development targeting either beta amyloid or tau, the company noted.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.