Lantheus: Alzheimer's Radiodiagnostic MK-6240 Achieves Co-Primary Endpoints in Key Studies

BEDFORD, Mass., April 30, 2025 – Lantheus Holdings, Inc., a leader in radiopharmaceuticals, has announced a significant achievement with its experimental radiodiagnostic tool, MK-6240. This F18-labeled tau Positron Emission Tomography (PET) radiodiagnostic has successfully met its co-primary endpoints in two critical studies, showcasing its sensitivity and specificity. These promising results suggest that MK-6240 could become an essential diagnostic tool. The company plans to use the study data to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), aiming for submission in the third quarter of 2025.

Luca Passamonti, MD, PhD, and Neuroscience Medical Director at Lantheus, emphasized the transformative potential of visualizing tau pathology in diagnosing and managing Alzheimer’s disease. He noted that tools like MK-6240 not only enhance clarity but also improve precision by accurately identifying tau accumulation early. This advancement could boost diagnostic confidence, personalize patient care, and provide new insights into the disease's progression, which has been lacking in the field. MK-6240, as a next-generation imaging agent, is poised to address this critical gap.

Lantheus CEO, Brian Markison, highlighted the significance of MK-6240's clinical results in the company's pursuit of cutting-edge imaging solutions tailored for Alzheimer’s disease. With MK-6240 achieving its primary endpoints in pivotal studies, Lantheus is approaching the delivery of this innovative radiodiagnostic, which could support accurate diagnoses and enhance disease management.

MK-6240 is specifically developed to target aggregated tau protein in neurofibrillary tangles (NFTs), a hallmark of neurodegenerative diseases like Alzheimer’s. The successful study completion advances MK-6240 as a potential tool for Alzheimer’s diagnosis, staging, and monitoring. This complements Lantheus’ other imaging agent, NAV-4694, which targets ß amyloid and is in Phase 3 development. Together, these imaging agents, if approved, could solidify Lantheus as a leader in radiopharmaceutical innovation and support the evolving diagnostic needs for neurodegenerative conditions.

The U.S. market for Alzheimer’s Disease radiodiagnostics is poised for growth due to rising prevalence, more treatment options, and expanded PET imaging guidelines. It could potentially reach over 400,000 scans, yielding a market value of $1.5 billion by 2030. Over 100 therapies are in various stages of development, aiming at either beta amyloid or tau.

Alzheimer’s disease is a degenerative neurological disorder leading to cognitive and functional decline. In the U.S., nearly 12 million individuals experience mild cognitive impairment or Alzheimer’s. As the population ages, this number is expected to increase, with projections indicating over 20 million affected individuals aged 65 and older by 2050.

MK-6240, acquired by Lantheus in 2023, is crafted to target tau proteins in NFTs, a characteristic of several neurodegenerative diseases. The compound has shown a strong affinity for tau with minimal off-target effects in both preclinical and clinical studies. Currently used in more than 100 active clinical trials, MK-6240 received Fast Track designation. It is anticipated to aid in early disease detection, patient staging, therapy selection, and monitoring. Additionally, it may facilitate tau serving as a surrogate endpoint for treatment efficacy. Lantheus plans to submit an NDA to the FDA in the third quarter of 2025.

Lantheus, a Massachusetts-based company with offices in New Jersey, Canada, and Sweden, has been at the forefront of radiopharmaceuticals for nearly 70 years, providing solutions to help clinicians find, fight, and follow diseases for better patient outcomes.