Lantheus Holdings, Inc. (NASDAQ: LNTH) announced today that its clinical-stage F18-labeled tau Positron Emission Tomography (PET) radiodiagnostic, MK-6240 (F18-florquinitau), has successfully met its co-primary endpoints in two pivotal studies assessing its sensitivity and specificity. This achievement marks a significant step forward in Alzheimer's disease diagnostics, with the company planning to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in the third quarter of 2025.
MK-6240 is specifically designed to target aggregated tau protein in the form of neurofibrillary tangles (NFTs), which are considered a key hallmark of Alzheimer's disease and several other neurodegenerative conditions. The radiodiagnostic has demonstrated high affinity for tau with limited off-target binding in both preclinical and clinical studies.
"As a clinician, the ability to visualize tau pathology represents the opportunity for a seismic shift in how we diagnose and manage Alzheimer's disease," said Luca Passamonti, MD, PhD, Neuroscience Medical Director at Lantheus. "Tools like MK-6240 offer more than just clarity - they provide precision. By identifying tau accumulation early and accurately, we have the potential to improve diagnostic confidence, tailor patient care, and, through monitoring, ultimately change what we know about the trajectory of disease progression."
Advancing Alzheimer's Diagnostic Capabilities
The successful completion of these pivotal studies positions MK-6240 as a potentially valuable tool in the evolving landscape of Alzheimer's disease management. The radiodiagnostic, which received Fast Track designation from the FDA, is currently being used in over 100 active clinical trials.
Brian Markison, CEO of Lantheus, emphasized the significance of these results: "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. 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."
The development of MK-6240 complements Lantheus' existing portfolio, which includes NAV-4694 (F18-flutafuranol), a β amyloid PET imaging agent currently in Phase 3 development. Together, these imaging agents could position Lantheus as a leader in radiopharmaceutical innovation for neurodegenerative conditions.
Market Potential and Disease Burden
The U.S. Alzheimer's Disease radiodiagnostic market shows significant growth potential, driven by rising disease prevalence, expanding treatment options, and updated PET imaging guidelines. Industry projections suggest the market could reach over 400,000 scans and $1.5 billion by 2030.
Alzheimer's disease represents a substantial and growing healthcare challenge. In the United States alone, nearly 12 million people are living with mild cognitive impairment or Alzheimer's disease. As the population ages, this number is expected to increase dramatically, potentially exceeding 20 million by 2050 among those aged 65 and older.
Clinical Applications and Future Impact
If approved, MK-6240 could transform several aspects of Alzheimer's disease management:
- Earlier Disease Detection: Identifying tau pathology before significant symptom onset
- Patient Staging: More accurately determining disease progression
- Therapy Selection: Guiding treatment decisions based on tau pathology presence and extent
- Disease Monitoring: Tracking changes in tau burden over time or in response to treatment
- Clinical Trials: Potentially serving as a surrogate endpoint for treatment efficacy
The radiodiagnostic was acquired by Lantheus in 2023 and has since been integrated into the company's neuroscience portfolio. With approximately 100 therapies currently in clinical development targeting either beta amyloid or tau, tools like MK-6240 could play a crucial role in both clinical practice and drug development.
About Lantheus
Lantheus is a leading radiopharmaceutical-focused company with nearly 70 years of experience providing diagnostic solutions. Headquartered in Massachusetts with additional offices in New Jersey, Canada, and Sweden, the company focuses on enabling clinicians to Find, Fight, and Follow disease to deliver improved patient outcomes.
