Enigma Biomedical USA Announces FDA Acceptance of New Drug Application for Tau PET Radiodiagnostic MK-6240 in Alzheimer’s Diseas
Biomedical USA (EB USA) today announced that the U.S. Food and Drug Administration (FDA) has formally accepted the New Drug Application (NDA) for MK-6240 (florquinitau F-18), the company’s novel Tau Positron Emission Tomography (PET) imaging radiodiagnostic designed to detect tau pathology in patients with Alzheimer’s disease (AD). This significant milestone marks a critical advancement in the field of neurodegenerative disease imaging and underscores the collaborative efforts between EB USA and Lantheus Holdings, Inc., which holds the global rights to MK-6240.
The FDA’s acceptance of the NDA validates the extensive research and clinical data supporting MK-6240’s potential to aid in the early and accurate diagnosis of Alzheimer’s disease, a condition affecting millions of individuals worldwide. Importantly, the FDA has already granted Fast Track designation to MK-6240, reflecting its potential to address an urgent unmet medical need and accelerate the availability of innovative diagnostic tools for patients and clinicians.
A Next-Generation Tau PET Tracer Targeting Alzheimer’s Disease Pathology
MK-6240, also known as florquinitau F-18, is a highly selective Tau PET imaging agent that binds specifically to tau neurofibrillary tangles (NFTs)—a key pathological hallmark of Alzheimer’s disease. NFTs, composed of abnormally aggregated tau protein, are one of the two defining features of AD, alongside amyloid-beta plaques. Accumulation of tau in specific brain regions has been strongly correlated with neuronal loss, cognitive decline, and disease progression, making tau imaging an essential component in both diagnosis and therapeutic development.
By visualizing and quantifying the presence of tau tangles in the living brain, MK-6240 offers researchers and clinicians a crucial tool for understanding disease mechanisms, stratifying patients, and monitoring response to emerging disease-modifying therapies. The radiotracer’s high binding affinity and low nonspecific uptake enable clear imaging contrast, facilitating accurate and reproducible measurements of tau pathology.
Clinical Progress and Regulatory Milestone
The NDA submission for MK-6240 was based on results from two pivotal Phase III studies, which demonstrated that the radiodiagnostic met its co-primary endpoints. In April 2025, Lantheus announced these positive results, confirming MK-6240’s diagnostic accuracy, safety, and clinical utility in identifying tau pathology associated with Alzheimer’s disease. The data supported the radiotracer’s role as a reliable biomarker for the presence and distribution of tau in the brain, correlating strongly with clinical severity and cognitive impairment.
With the NDA now accepted, the FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of August 13, 2026. This provides a clear regulatory timeline for potential approval, bringing MK-6240 one step closer to clinical use as a diagnostic tool to aid physicians in the assessment of Alzheimer’s disease progression.
Strategic Collaboration Driving Innovation
The development of MK-6240 represents a successful partnership between Enigma Biomedical USA and Lantheus, uniting deep expertise in radiopharmaceutical development and molecular imaging. Lantheus, a leader in precision diagnostics and targeted radiopharmaceuticals, acquired the global rights to MK-6240 in 2023. Since then, Lantheus has worked closely with the Enigma team to advance clinical development, validate the tracer’s clinical utility, and prepare for regulatory submission.
“EB USA is extremely excited about the FDA’s acceptance of the MK-6240 NDA and we extend our congratulations to our partners at Lantheus for achieving this important regulatory milestone,” said Rick Hiatt, President and CEO of Enigma Biomedical USA. “This accomplishment represents not only a major step forward in our shared mission to address critical unmet needs in neurodegenerative diseases, but also highlights our ongoing commitment to developing tools and technologies that can accelerate the discovery of disease-modifying therapies.”
Hiatt emphasized that MK-6240 embodies Enigma’s mission to enable precision diagnostics that support both clinical care and therapeutic innovation. “As we continue to learn more about the biology of Alzheimer’s disease, tools like MK-6240 are essential for identifying patients who may benefit most from emerging treatments, as well as for monitoring disease progression in real time,” he added.
Advancing Precision Medicine in Alzheimer’s Disease
Alzheimer’s disease remains one of the most challenging and devastating neurodegenerative disorders, with more than 55 million people worldwide living with dementia. While several amyloid-targeting therapies have recently been approved, tau pathology continues to represent a critical target for both diagnosis and treatment. Studies have shown that the extent and distribution of tau tangles correlate more closely with cognitive decline than amyloid burden, underscoring the importance of reliable tau imaging agents like MK-6240.
“By enabling early and accurate identification of tau accumulation, MK-6240 has the potential to enhance diagnostic confidence, personalize patient care, and, through ongoing monitoring, transform our understanding of disease progression,” said Brian Markison, CEO of Lantheus. “We are pleased that the FDA has accepted our NDA for MK-6240 and are deeply grateful for the continued support and expertise of the Enigma team, whose contributions have been instrumental to this achievement.”
Markison also noted that MK-6240 aligns with Lantheus’ broader mission to improve patient outcomes through precision diagnostics. “We believe MK-6240 will play an essential role in the evolving Alzheimer’s disease treatment landscape by enabling better-informed clinical decisions, supporting therapeutic trials, and ultimately helping to bring new hope to patients and their families,” he said.
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