FDA Accepts NDA for PET Imaging Agent for Tau Pathology in Alzheimer Disease

The Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for MK-6240 (Lantheus Holdings, Bedford, MA), an investigational F18-labeled PET imaging agent designed to detect tau neurofibrillary tangles (NFTs) in people who are being evaluated for Alzheimer disease (AD) and have cognitive impairment. The FDA granted MK-6240 Fast Track designation and set a target action date of August 13, 2026, under the Prescription Drug User Fee Act (PDUFA).

MK-6240 is designed to bind selectively to aggregated tau protein while minimizing off-target binding, potentially enabling clinicians to visualize and stage disease more precisely. In April 2025, the company announced that the coprimary end points of 2 pivotal studies which assessed the agent’s sensitivity and specificity of MK-6240 to detect tau pathology were met. According to a statement from Lantheus Holdings, the company submitted data from the 2 phase 3 studies to support the NDA submission.

Brian Markison, CEO of Lantheus Holdings, commented that “If approved, MK-6240 would complement beta-amyloid PET imaging and emerging blood-based diagnostics, helping guide treatment strategies for providers and patients.”

Sources: Lantheus Holdings, Inc. Lantheus announces Alzheimer’s disease radiodiagnostic MK-6240 meets co-primary endpoints in two pivotal studies. GlobeNewswire. Published April 30, 2025. Accessed October 30, 2025. https://www.globenewswire.com/news-release/2025/04/30/3071338/0/en/Lantheus-Announces-Alzheimer-s-Disease-Radiodiagnostic-MK-6240-Meets-Co-Primary-Endpoints-in-Two-Pivotal-Studies.html

Lantheus Holdings, Inc. Lantheus announces FDA acceptance of New Drug Application for MK-6240, a PET imaging agent targeting tau in Alzheimer’s disease. Lantheus. Published October 28, 2025. Accessed October 30, 2025. https://lantheusholdings.gcs-web.com/news-releases/news-release-details/lantheus-announces-fda-acceptance-new-drug-application-mk-6240